Valeda™ PBM Photobiomodulation
For Dry AMD
Valeda™ PBM photobiomodulation is now offered at New England Retina Associates.
Photobiomodulation is a light-based therapy. A benchtop device delivers three specific wavelengths of low-level LED light to the retina, with nothing touching the eye, no dilation, no anesthesia, and no injection.
On November 4, 2024, the U.S. Food and Drug Administration granted De Novo marketing authorization to the Valeda Light Delivery System. That made it the first FDA-authorized treatment intended to improve vision in early and intermediate dry age-related macular degeneration.
De Novo authorization is not full FDA approval, and results vary by individual. This page lays out plainly what the treatment offers, what it asks of you, and what it does not do.
3
wavelengths of LED light: 590, 660, and 850 nm
Under 5
minutes of light per eye in a treatment session
Device specification from the FDA De Novo device record for the Valeda Light Delivery System, 2024, and from the published LIGHTSITE III trial reports in Retina, 2024 and 2026.
The criteria are specific: four findings have to be true at the same time, and only a dilated exam with retinal imaging can confirm them.
Four findings have to be true at once. An exam with imaging confirms them.
Treatment Overview
A Light-Based Option Inside Dry AMD Care
New England Retina Associates (NERA) is a retina-only specialty practice caring for patients across Connecticut since 1995. Three fellowship-trained vitreoretinal surgeons read the imaging, stage the disease, and decide together what belongs in a treatment plan. This page covers one therapy, photobiomodulation, which means treating tissue with low-level light rather than with drugs, surgery, or a cutting laser.
NERA physicians are actively involved in clinical research, studying new treatments for conditions including macular degeneration, diabetic eye disease, and retinal vein occlusions. Ask your NERA physician whether a clinical trial may be appropriate for your condition.
For the disease itself, start with the overview of dry macular degeneration and the separate page on wet macular degeneration. This page does not repeat that material. It stays on the therapy: what the light does, who the authorization covers, what a course of treatment asks of you, and what the trials did and did not find.
One piece of context belongs here rather than in the headline. Two drug therapies for geographic atrophy, the advanced form of dry AMD in which patches of retinal tissue wear away, were approved earlier, in February 2023 and August 2023. They are intended to slow lesion growth rather than improve vision. That is why the Valeda™ PBM claim is stated narrowly: first FDA-authorized treatment intended to improve vision in early and intermediate dry AMD.
All three NERA physicians manage age-related macular degeneration across its full course, from early dry AMD through advanced geographic atrophy. Dr. John Siano brings additional depth through his focus on geographic atrophy and emerging therapeutics, and Dr. Gregory Haffner is an active investigator in clinical trials for macular degeneration. Photobiomodulation is one option among several, and your doctor will recommend the best approach for your specific condition.
About This Page
What Photobiomodulation Is
Three wavelengths of low-level light, delivered from LEDs in a fixed sequence, aimed at the energy machinery inside retinal cells.
The device is a benchtop instrument, roughly the size of the equipment you already rest your chin on during an eye exam. It emits non-coherent light from light-emitting diodes at three wavelengths: 590 nanometers, which reads as yellow or amber, 660 nanometers, which is red, and 850 nanometers, which is near-infrared and invisible. It is not a laser and it is not the thermal laser used to seal retinal tissue. Nothing is cut, burned, or injected.
How the light is delivered, and the device names
The wavelengths are not delivered all at once. The 590 nm and 850 nm light is pulsed while the eye is open, and the 660 nm red light is continuous and delivered through the closed eyelid, so a technician tells you when to open and when to close. The whole exposure runs under five minutes per eye.
Valeda™ PBM is the promotional product name. The regulatory labeling calls the same device the Valeda Light Delivery System, and the safety block further down this page quotes that labeling word for word.
The three wavelengths, and what each one is for
590 nm, Yellow
Chosen on a different rationale from the other two. In laboratory retinal cell cultures it reduced production of vascular endothelial growth factor, a protein involved in abnormal blood-vessel growth. That is a cell-culture finding, and it does not mean the therapy treats wet AMD.
660 nm, Red
Absorbed by copper sites inside cytochrome c oxidase, an enzyme in the mitochondria, which are the structures that generate a cell's energy. Laboratory work shows it enhancing oxygen binding at the enzyme's active site.
850 nm, Near-Infrared
Absorbed at a second copper site in the same enzyme, where it supports electron flow through the mitochondrial respiratory chain. You cannot see it, so the light looks dimmer than it is.
LED, Non-Laser, Non-Coherent
The light comes from diodes and is non-coherent, meaning the waves are not aligned the way laser light is. That is the technical difference between photobiomodulation and any retinal laser procedure.
The Proposed Mechanism
Retinal cells are among the most energy-hungry in the body, and mitochondria are their power plants. In dry AMD those power plants become less efficient, waste products accumulate, and cells come under stress. The working theory is that red and near-infrared light absorbed by cytochrome c oxidase supports production of adenosine triphosphate, the cell's energy currency, while reducing reactive oxygen species, a damaging form of cellular waste, and increasing antioxidant protection.
How firm the mechanism evidence is
That chain is a plausible, laboratory-supported rationale rather than a proven in-human causal explanation, and the peer-reviewed literature describes it as how the treatment theoretically works. The American Academy of Ophthalmology draws the regulatory distinction just as plainly, noting that the FDA has authorized rather than fully approved (opens in a new tab) the treatment (American Academy of Ophthalmology, 2024).
The honest framing: the light is real, the wavelengths are specified, the trials measured what they measured, and the biology connecting the two is still a hypothesis. Results vary by individual, and no one should read the mechanism as a promise about their own eye.
Am I A Candidate
Valeda™ PBM is authorized for a specific window of dry AMD. A dilated exam with retinal imaging tells us quickly whether your eye sits inside it.
Four findings from the labeling have to be true together. They are not alternatives, and someone who meets three of the four does not qualify. This is the most commonly misunderstood point about the therapy.
All four must be true at the same time, in the eye being treated
Also assessed at the visit
These two are not part of the four-part labeling test. They are separate considerations that come up at the same appointment.
Who This Is Not For
What Screening Involves
Candidacy is a measurement, not an opinion. Acuity is measured with best correction in place. The size and count of drusen, the yellow deposits under the retina that mark dry AMD, and the presence and location of atrophy, come from retinal imaging, usually optical coherence tomography, a cross-sectional scan of the retinal layers.
Expect the evaluation visit to include dilation, so arrange a driver for that appointment even though treatment sessions themselves do not require one. The evaluation can be scheduled at any NERA office; bring your insurance card and a current medication list, since screening includes a check for photosensitizing agents.
Two boundaries matter for cost as well as care. Treating an eye that has both wet and dry disease is off-label, and so is treating an eye with intermediate dry AMD plus center-involving atrophy. Off-label use is typically not paid by insurers, and the patient carries the cost.
Wet AMD in one eye does not by itself disqualify the other eye; the pivotal trial enrolled patients in exactly that situation. It does warrant a candid conversation, because a wet eye is a recognized risk factor for the fellow eye.
One last point, about who benefits rather than who qualifies: in the manufacturer's own reporting, patients with early-stage disease did only about 0.29 letters better than untreated eyes at Month 24, even though early disease sits inside the indication (Alcon labeling summary, 2026). Results vary by individual, and your retina specialist will recommend the best approach for your specific condition.
Ask About A Dry AMD Evaluation
What A Treatment Session Is Like
Short, needle-free, and no dilating drops. Here is the sequence from walking in to walking out.
In The Chair
Before, During, And After
Nothing has to change beforehand: no dietary restrictions, no medications to stop, no drops ahead of time. Glasses or contact lenses come off, and you sit at the device much the way you would sit at a standard eye-exam instrument. Nothing touches the eye.
Valeda™ PBM delivers three wavelengths from LEDs rather than lasers: 590 nm yellow, 660 nm red, and 850 nm near-infrared. Two of the three are delivered while the eye is open and one through the closed eyelid, so a technician tells you when to open and when to close. It is not one long stare into a light.
Most people feel nothing at all. Some describe a mild sense of warmth. You will see the light. Tell the technician right away if anything feels uncomfortable.
Under 5 Minutes Per Eye
Light delivery runs less than five minutes per eye. Alcon's patient materials describe treating both eyes in about 10 minutes or less; check-in and vision checks add to the total time in the office.
No Dilation For Treatment
Treatment sessions use no dilating drops, so most people drive themselves home. Evaluation and the check-up exams between series usually do involve dilation, so plan for a driver on those visits.
No Needles, No Anesthesia
Nothing is injected and nothing numbs the eye. Only light is used.
No Downtime
A brief afterimage, like the spot left by a camera flash, can linger for a couple of minutes. Normal activities resume the same day.
A Session, Step By Step
Check In
Standard check-in, sometimes with a brief vision check. Plan on roughly 30 to 45 minutes of total office time; the light itself is a small part of that.
Get Positioned
Glasses or contacts come off. You rest against the device and a technician guides each step.
The Light Sequence
Yellow, red, and near-infrared light are delivered in a set order, under five minutes per eye.
Head Home
No patch, no drops, no recovery period. Normal activities resume the same day.
The Treatment Schedule
Photobiomodulation is given as a series, not as a single procedure. The schedule below is the one studied in the pivotal trial and described in the labeling. What patients received in return for that commitment is covered in the evidence section that follows.
9
Sessions Per Series
3
Sessions Per Week
3-5
Weeks Per Series
4
Months Between Series
Protocol as delivered in the LIGHTSITE III trial, reported in Retina, 2026: nine treatments delivered three times a week over three to five weeks, every four months.
How A Year Of Treatment Fits Together
Evaluation First
A dilated exam and retinal imaging establish whether an eye qualifies; self-assessment cannot.
One Series
Nine sessions, three a week, spread across three to five weeks. Sessions are not given twice in one day.
Repeat Every 4 Months
A follow-up exam, then the next series. Three series a year is the cadence the trial used, which comes to 27 sessions per eye per year.
Year Two And Beyond
The pivotal trial ran six series over 24 months, 54 treatments per eye. Labeling notes there is no data supporting more than 54 total treatments per eye.
That is a real, ongoing commitment: nine visits inside a five-week window, three times a year, continued rather than completed. Evaluations can be scheduled at any of NERA's four Connecticut offices; ask which office will host your treatment sessions when you book. Weigh the commitment against travel, work, and caregiver schedules before starting rather than after. Continuation past two years has no published fixed protocol, so your doctor will recommend the best approach for your specific condition.
What The Evidence Shows
Three randomized, sham-controlled trials support the therapy. For transparency, every treated figure below is shown alongside its sham comparison, because in these trials the sham group improved too.
The FDA-authorized labeling states that the treatment provides approximately one line of visual acuity improvement on the ETDRS chart, the standardized eye chart used in vision research, at about two years compared with untreated eyes. That is the labeled effect size, and it is the most conservative way to describe what the trials found. Results vary by individual.
What LIGHTSITE III actually measured
LIGHTSITE III
LIGHTSITE III was a double-masked, randomized, sham-controlled, multicenter study of 100 patients and 148 eyes at 10 United States centers, randomized 2 to 1 in favor of treatment.
At 13 months, treated eyes gained an average of 5.4 letters on the eye chart and sham eyes gained 3.0 letters (P = 0.02). The sham group's improvement was itself statistically significant, which is why both numbers belong in the same sentence.
Also at 13 months, 55.0% of treated eyes gained five letters or more against 40.8% of sham eyes, and 26.4% gained ten or more against 14.9%. New geographic atrophy appeared in 1.1% of treated eyes, 1 of 87, against 10.0% of sham eyes, 5 of 50 (P = 0.024). Those event counts are very small.
The trial met its prespecified primary vision endpoint at Month 21, not Month 24, with a 6.2-letter gain in treated eyes (P = 0.0036). At Month 21, 61.5% of treated eyes gained five letters or more, 23.1% gained ten or more, and 4.4% gained fifteen or more.
The published abstract gives the between-group p-value but no sham value for the Month 21 gain or those responder rates. The 6.2 figure is therefore a within-arm change, not the sham-adjusted effect. The FDA's De Novo decision summary does report the sham-adjusted figure: at Month 21 the treated group's gain was 3.8 letters larger than the sham group's (95% CI 1.2 to 6.3).
The peer-reviewed 24-month analysis (Retina, 2026) reports the paired figure at Month 24: treated eyes improved by 5.6 letters against 1.3 letters in the sham group (P = 0.0024), and 63.7% of treated eyes gained five letters or more against 22.2% of sham eyes.
The company's earlier conference announcement of the same timepoint had reported 5.9 letters against 1.0 (P = 0.0015); the peer-reviewed values are the ones this page quotes.
At Month 24, progression to geographic atrophy occurred in 6.8% of treated eyes against 24.0% of sham eyes (P = 0.007). That is a 71.7% relative reduction in new geographic atrophy, and it is the strongest single result in the program.
What LIGHTSITE I and II found
LIGHTSITE I And II
LIGHTSITE I was a single-center, double-masked, randomized, sham-controlled study of 30 subjects and 46 eyes, published in Retina in 2020. Treated subjects gained about 4 letters after each treatment series, and about 50% gained five letters or more against 13.6% of sham subjects. It is a pilot, and no number from it should carry a headline.
LIGHTSITE II enrolled 44 patients and 53 eyes across Europe. Among patients who completed all 27 treatments, a subgroup of 29 eyes, treated eyes gained 4 letters at 9 months against 0.5 letters in the sham group. The treated eyes' improvement from baseline was statistically significant (P = 0.02); the 0.5-letter sham change was not, and no between-group p-value was published for that pairing. 35.3% of treated eyes gained five letters or more.
LIGHTSITE II also reported 20% less geographic atrophy lesion growth in the treated group over 10 months. No p-value was published for that comparison, so it is a trend rather than a significant finding.
All three LIGHTSITE trials were sponsored by the device manufacturer, and company employees appear as co-authors on all three papers. That is disclosed in the publications and is one of the criticisms discussed below.
What It Does, And What It Does Not Do
The benefits above come with boundaries, and we would rather you hear them from us than find them later. Here is what the trials did not show and what is still uncertain.
Photobiomodulation is an addition to dry AMD care with a measurable, modest benefit. It is not a cure, and it does not restore vision that has already been lost.
It also does not replace anti-VEGF injections for wet AMD: it has no indication, no trial data, and no mechanism claim for that disease. And the evidence base is still developing: three modest randomized trials, all industry-sponsored, with the longest follow-up coming from an uncontrolled open-label extension.
Where the evidence has limits
What The Trials Did Not Show
Drusen Volume Did Not Change Significantly
In LIGHTSITE III, the change in macular drusen volume at 13 months was not statistically different between the treated and sham groups (P = 0.36). Marketing language about reducing drusen is not supported by that result.
Existing Atrophy Did Not Grow More Slowly
Growth of existing geographic atrophy lesions was not significantly different at 13 months, +1.16 mm² treated against +1.48 mm² sham (P = 0.75). The atrophy benefit reported in the trial is about new atrophy appearing, not about existing atrophy growing more slowly. Those are different claims and must not be blended.
Contrast And Reading Stayed Flat; Quality Of Life Improved Later
Low-luminance acuity, contrast sensitivity, reading charts, and the vision quality-of-life questionnaire showed no between-group benefit at 13 months, which the authors attributed to a ceiling effect. Claims about better contrast, low-light vision, or easier reading go beyond the trial's secondary endpoints. One later bright spot: the 24-month analysis (Retina, 2026) reported a significant improvement over sham on the VFQ-25 vision quality-of-life score at Month 21 (P = 0.02), maintained in treated eyes at Month 24 while the sham group declined.
Early-Stage Patients Saw Minimal Benefit
According to the FDA decision summary and Alcon labeling material, patients with early-stage AMD did only about 0.29 letters better than sham at Month 24. That is a between-group difference on the primary endpoint, not a within-arm gain. Early AMD sits inside the authorized indication, which makes that a material qualifier rather than a footnote.
Benefit May Not Persist After Treatment Stops
The labeling states it plainly: "It is possible that treatment benefit may not persist significantly after treatment is stopped." In the roughly 20-month gap between LIGHTSITE III and its extension study, previously treated eyes lost about 2 letters and former sham eyes lost about 6. When treatment resumed, the previously treated eyes regained vision, while former sham eyes stabilized but recovered little. This is a maintenance therapy, not a one-time fix.
Safety signals, bias, and outside commentary
How Strong The Evidence Is
Ocular Adverse Events In 22.3% Of Study Eyes
In LIGHTSITE III, ocular adverse events occurred in 22.3% of study eyes, with no single ocular event above 5%. Four were treatment-related, all mild to moderate, and none led to discontinuation. The three device-related events were all dry eye.
Wet AMD Conversion Was Higher In Treated Eyes
Conversion to wet AMD occurred in 5.4% of treated eyes against 1.8% of sham eyes at 13 months. No p-value was reported and no source claims the treatment caused it, but the difference is real and it belongs on this page. Patients stay under retinal surveillance either way.
A 2024 Meta-Analysis Found A Small Pooled Effect
A 2024 systematic review pooling all three randomized trials, 247 eyes, found a gain of 1.76 ETDRS letters (95% CI 0.04 to 3.48, P = 0.04), below the 6.8-letter threshold those authors used for a minimal clinically important difference. The same review rated all three trials at high risk of bias. It does not include the 24-month results.
The Sham Arm Was Not A True Placebo
The sham used reduced-fluence light rather than no light, and the trial authors acknowledge it "could be considered an active control arm, which also showed moderate improvements in BCVA." BCVA is best-corrected visual acuity, the standard eye-chart measure. That leaves the true placebo-adjusted effect size uncertain in either direction.
Independent Commentary Urges Caution
Reviewing the trial for the American Academy of Ophthalmology in 2024, Ajay Kuriyan, M.D., noted that the study was relatively small, that both groups improved in a way that would not have been anticipated, and that more real-world, long-term studies will be needed to fully assess the potential benefits.
The Trial Population Was Not Racially Diverse
Per the FDA decision summary, no non-white subjects received the treatment in the pivotal study, and the FDA states the device's performance in non-white patients is unknown, with limited data in patients of Hispanic or Latino origin. That gap is part of any honest candidacy conversation.
Off-Label Use Is Outside The Evidence
Treating an eye that has wet AMD, or center-involving geographic atrophy, falls outside the authorized indication. It is off-label, and health plans typically do not pay for it.
The labeling quote on stopping treatment
From the FDA-authorized labeling: "It is possible that treatment benefit may not persist significantly after treatment is stopped. The clinical study provided no significant data concerning the safety and effectiveness of the device should treatments be applied more frequently than described in this manual, or if more than 54 total treatments are delivered per eye."
None of this makes photobiomodulation a poor option. It makes it an option with a measurable but modest effect, a genuine time commitment, and an evidence base that is still maturing. Results vary by individual, and your doctor will recommend the best approach for your specific condition after an examination and imaging.
Talk It Through With A Retina Specialist
Safety And The Important Safety Information
The therapy was well tolerated in the trial that supported its authorization, and the labeling still sets firm limits on who should receive it. Both halves belong on the same page.
What the trial safety data showed
In LIGHTSITE III, the pivotal trial behind the authorization, ocular adverse events were reported in 22.3% of study eyes, and no single ocular adverse event was reported at a frequency above 5% (Retina, 2024). Four ocular adverse events were judged treatment-related. All four were mild to moderate, and none caused a patient to stop treatment.
Three adverse events were classified as device-related, and all three were dry eye. Follow-up through 24 months reported a favorable safety profile with no signs of phototoxicity, within the studied dose and schedule (LIGHTSITE III 24-month data, 2026). Any new symptom during a series should be reported the same day.
22.3%
Ocular adverse events, all study eyes
3
Device-related events, all dry eye
0
Signs of phototoxicity through 24 months
LIGHTSITE III safety analysis, Retina, 2024, and the LIGHTSITE III 24-month report, 2026.
Full Indications for Use and Contraindications
The text in this block is reproduced word for word from the Valeda labeling. It uses the device's regulatory name, the Valeda Light Delivery System, which is the name the FDA authorization applies to. Elsewhere on this page the same system is called Valeda™ PBM, the manufacturer's promotional name.
Indications For Use
The Valeda Light Delivery System is intended to provide improved visual acuity in patients with best-corrected visual acuity of 20/32 through 20/70 and who have dry age-related macular degeneration (AMD) characterized by:
- The presence of at least 3 medium drusen (> 63 µm and ≤ 125 µm in diameter), or large drusen (> 125 µm in diameter), or non-central geographic atrophy, AND
- The absence of neovascular maculopathy or center-involving geographic atrophy.
After about two years, the Valeda Light Delivery System treatment provides improved mean visual acuity of approximately one line of visual acuity (ETDRS) compared to those not receiving the treatment.
Contraindications For Use
As a precaution, patients have not been tested and should not be treated with Valeda if they have any known photosensitivity to yellow light, red light, or near-infrared radiation (NIR), or if they have a history of light-activated central nervous system disorders (e.g., epilepsy, migraine). In addition, patients should not receive treatment within 30 days of using photosensitizing agents (e.g., topicals, injectables) that are affected by 590, 660, and/or 850 nm light before consulting with their physician.
Precautions
It is possible that treatment benefit may not persist significantly after treatment is stopped. The clinical study provided no significant data concerning the safety and effectiveness of the device should treatments be applied more frequently than described in this manual, or if more than 54 total treatments are delivered per eye.
Transcription note: the printed brochure renders the first bullet as "> 63 µm and = 125 µm". The equals sign is a font-substitution artifact for the less-than-or-equal-to sign, so the bound is shown above as ≤ 125 µm. No other wording in these three blocks has been altered.
Two points that are often misreported
Pregnancy is not a stated contraindication. It appears instead under precautions, among the situations in which safety has not been established, which is a statement about missing evidence rather than a prohibition.
According to Alcon's professional labeling summary, safety has also not been established in patients under age 50, in patients who are nursing, or in patients with cataract or other media opacity, posterior capsule opacification, pupil obstruction, or significant eye disease other than AMD (2026). Screening for all of it happens at the examination.
Cost And Coverage
Billing for photobiomodulation is real, active, and still unsettled. Here is exactly where it stands.
Photobiomodulation of the retina is billed under CPT Category III code 0936T, which took effect on January 1, 2025. Category III codes are temporary codes used for emerging technology. That status, more than anything else, is what keeps coverage decisions unsettled rather than routine.
How billing and coverage currently work
The Centers for Medicare and Medicaid Services did not assign a payment amount to 0936T in the 2025 Medicare Physician Fee Schedule. Medicare Administrative Contractors, the regional companies that process Medicare claims, therefore decide these claims case by case rather than against a published national rate (Retinal Physician, 2025).
Because payment is not guaranteed, an Advance Beneficiary Notice is advised for Medicare patients before treatment begins. It is a plain-language form stating that Medicare may not pay and that the patient may be financially responsible, signed before the first session rather than discovered after it (Retinal Physician, 2025).
Commercial payers had not published formal coverage policies for photobiomodulation as of late 2025, and some carriers may still classify it as investigational (Retinal Physician, 2025). The American Academy of Ophthalmology (opens in a new tab) noted at the time of authorization that the out-of-pocket cost to patients is not yet known (AAO, 2024).
One point is settled, and it corrects a common misunderstanding: photobiomodulation is not exclusively a cash-pay procedure. A reimbursement consultancy that advises retina practices has answered that exact question: no, claims are sometimes paid by health plans (2025). The opposite caution also applies. Treating an eye that has wet AMD, or an eye with center-involving geographic atrophy, falls outside the authorization, and those claims are typically not paid (2025).
Plan participation is a separate question
Two Separate Questions
Keep these apart. The first is which plans this retina-only specialty practice participates in. The second is whether a given plan will pay for photobiomodulation, which is not yet established for any carrier. An answer to the first is not an answer to the second.
NERA accepts most major insurance plans including Medicare, Medicaid, Aetna, Anthem, Cigna, Connecticare, United Healthcare, and more. Coverage and benefits vary by plan. Please contact your nearest NERA location to confirm your specific coverage before your appointment.
That paragraph describes plan participation. It is not a statement that photobiomodulation is a paid benefit under any of those plans.
Ask For A Benefits Check Before The First Series
Coverage is decided claim by claim, so the useful step is a written benefits check and a cost estimate before any series begins. Ask what an Advance Beneficiary Notice would mean for you, and what happens if a claim comes back denied. Nobody should start a nine-visit series without those answers in hand.
How It Fits With The Rest Of Dry AMD Care
Photobiomodulation is added to a dry AMD plan. It is not swapped in for one.
Valeda™ PBM sits inside a larger plan alongside supplements, diet, not smoking, home monitoring, and regular imaging with a retina specialist. It is not a cure for dry macular degeneration, and it does not replace anti-VEGF therapy for the wet form. The pivotal trial tested light therapy added to that kind of care, not in place of it.
| Part of a dry AMD plan | What it is for | How Valeda™ PBM relates to it |
|---|---|---|
| AREDS2 supplementation | An antioxidant and zinc formula an eye doctor may recommend for intermediate disease or significant drusen (American Academy of Ophthalmology, 2026). | Taken alongside, never instead. In LIGHTSITE III, 86.0% of participants were already taking AREDS supplementation while they received light therapy, and supplement use was built into the statistical model (2024). |
| Complement inhibitor injections | In-office injections the FDA approved in 2023 to slow the growth of existing geographic atrophy, the advanced form of dry AMD. | A different approach with a different target. Photobiomodulation is authorized for early and intermediate disease and for non-central geographic atrophy. Center-involving geographic atrophy sits outside its indication. |
| Anti-VEGF injections | The treatment for wet macular degeneration, given when abnormal vessels leak under the retina. Detail lives on the retina treatment pages. | Not interchangeable. Photobiomodulation has no indication, no trial data, and no mechanism claim for wet AMD. If an eye converts, the plan for that eye moves to anti-VEGF injections. |
| Home monitoring | A daily Amsler grid check held at 12 to 15 inches, with wavy, blurry, or distorted lines reported right away (AAO, 2026). Download and print out the Amsler grid | More important during a treatment series, not less. Home monitoring is how a conversion to wet AMD gets caught between scheduled visits. |
| Low vision services | Vision rehabilitation, magnifiers, and electronic aids that help a person make the most of the vision they have (AAO, 2026). | Complementary, and still needed. Photobiomodulation does not restore vision already lost. The labeled effect is roughly one line of ETDRS acuity at about two years compared with no treatment. |
Care-plan components summarized from the American Academy of Ophthalmology (opens in a new tab) (2026). Trial figures from LIGHTSITE III (2024).
The trial authors framed the gap plainly: existing antioxidant supplementation delays progression in only about 20% to 25% of eyes (2024). That is the space photobiomodulation is positioned to occupy, which is a reason to consider adding something, not a reason to stop anything already working.
Results vary by individual, and your doctor will recommend the best approach for your specific condition after an examination and imaging. A sudden change in central vision, new distortion, or a new dark spot is not something to watch and wait on. Call the nearest NERA office the same day.
Patient Resources
Materials to read before your evaluation, share with family, or keep handy during a treatment series.
Information For Referring Optometrists And Ophthalmologists
How the authorization defines the indication
Photobiomodulation of the retina was authorized by the FDA through the De Novo pathway in November 2024, as a Class II device with special controls under request DEN230083. The indication is narrow, and its four conditions travel together: best-corrected acuity of 20/32 to 20/70, at least 3 medium drusen or large drusen or non-central geographic atrophy, no wet AMD, and no center-involving geographic atrophy in the eye under consideration. The full Indications for Use and Contraindications are quoted earlier on this page, and the screening lists below are a decision aid, not a substitute for them. The lists combine the authorized indication with the LIGHTSITE III trial's own eligibility criteria. The trial criteria are not part of the labeling; several trace to the FDA De Novo decision summary (DEN230083). Treat them as clinical context rather than as authorization requirements.
Referral criteria, and what to flag
Refer If
- Age 50 or older
- Non-neovascular (dry) AMD at the intermediate stage, or late dry AMD with non-central geographic atrophy
- Best-corrected acuity of 20/32 to 20/70 in the eye under consideration
- At least 3 medium drusen (greater than 63 and up to 125 micrometers), or any large drusen (greater than 125 micrometers), or non-central geographic atrophy
- Drusen and atrophy attributable to AMD
- Media clear enough to refract and image, with no lens surgery or capsulotomy anticipated in roughly the next two years
- No photosensitivity to yellow, red, or near-infrared light
- Intraocular surgery in that eye more than 3 months ago
- Able and willing to attend 9 visits per series, roughly 3 series a year
- Counseled in advance that coverage is not established
Do Not Refer If
- Under age 50
- Any current or prior neovascular maculopathy in that eye, including choroidal neovascularization, serous or hemorrhagic detachment, hard exudate, fibrovascular proliferation, or disciform scar
- Best-corrected acuity better than 20/32 or worse than 20/70
- Center-involving geographic atrophy
- Drusen or atrophy from a non-AMD cause, such as Stargardt disease, autosomal dominant drusen, North Carolina macular dystrophy, or mitochondrial disease
- Visually significant cataract, posterior capsule opacification, or pupil-obstructing disease
- Other visually significant ocular disease, including diabetic macular edema, advanced or uncontrolled glaucoma, active uveitis, intraocular tumor, or retinal vascular disease
- Known photosensitivity to 590, 660, or 850 nm light, a light-activated central nervous system disorder, or a photosensitizing agent within the last 30 days
- Intraocular surgery in that eye within the last 3 months
- Pregnant or nursing, where safety has not been established
- Unable to commit to the visit burden
Refer, But Flag It
- Early-stage AMD. The patient may still meet the written indication, but according to Alcon labeling, patients with early-stage AMD showed minimal benefit at Month 24, a between-group difference versus sham of about +0.29 letters. Weigh that before referring on drusen alone.
- Fellow eye with wet AMD. Still referable, and worth flagging. Conversion to wet AMD occurred in 5.4% of treated eyes versus 1.8% of sham eyes at 13 months, with no causal claim made by any source.
- Progressive cataract. Safety has not been established in eyes with media opacity, and a lens change moves acuity independently. Treat the cataract first, then re-measure against the 20/32 to 20/70 band.
The Numbers A Referring Doctor Will Ask For
Sham-paired effect sizes and the safety record
Labeled Effect
The authorized labeling states the treatment provides approximately one line of ETDRS acuity improvement at about two years compared with untreated eyes. That is the most conservative and most defensible number available.
Acuity At 13 Months
Treated eyes gained an average of 5.4 letters versus 3.0 letters in the sham group (P = 0.02). The sham arm improved significantly as well, and it delivered reduced-fluence light that the authors acknowledge "could be considered an active control arm."
New Atrophy At 24 Months
Progression to geographic atrophy occurred in 6.8% of treated eyes versus 24.0% of sham eyes (P = 0.007), a 71.7% relative reduction. Event counts are small, and growth of atrophy that already existed was not significantly different.
The Pooled Estimate
A 2024 meta-analysis of the three randomized trials (247 eyes) found a pooled gain of 1.76 ETDRS letters, below the 6.8-letter threshold the authors set for a minimal clinically important difference, and rated all three trials at high risk of bias. It does not include the 24-month results.
What Did Not Separate From Sham, And What The Safety Record Shows
Drusen volume change was not significantly different at 13 months (P = 0.36), which is worth knowing before a patient repeats a "reduces drusen" claim back to you. Ocular adverse events occurred in 22.3% of study eyes, with no single ocular adverse event above 5%; only 4 ocular adverse events were treatment-related, all mild to moderate, and none led to discontinuation. The three device-related adverse events were all dry eye, and no signs of phototoxicity were observed over 24 months.
Labeling states that treatment benefit may not persist significantly after treatment is stopped, so this is an ongoing therapy rather than a course that finishes. American Academy of Ophthalmology commentary from reviewer Ajay Kuriyan, M.D., notes that the trial was relatively small, that both groups improved unexpectedly, and that longer real-world studies are needed (AAO, 2024).
Photobiomodulation is not a cure for dry AMD and does not replace anti-VEGF therapy for wet AMD. Treating an eye that has wet AMD, or center-involving geographic atrophy, is off-label and typically not covered. The evidence base is early and still developing, and it should be presented to patients that way.
The evaluation, and what comes back to you
What A Photobiomodulation Candidacy Referral Involves
Candidacy is confirmed by examination and imaging, not by self-assessment and not from the referral note alone. The evaluation establishes whether the eye sits inside the authorized indication:
- Protocol refraction and best-corrected acuity, to confirm the eye falls inside the 20/32 to 20/70 band
- Macular volume scan on optical coherence tomography, to size and count drusen and to exclude subretinal or sub-RPE fluid
- Fundus autofluorescence, to establish the extent and centrality of atrophy
- Color fundus photography for baseline documentation
- OCT angiography where occult neovascularization is a concern
- Lens and media assessment, plus a medication review for photosensitizing agents
If an eye qualifies, the studied protocol is a series of 9 sessions delivered 3 times a week over 3 to 5 weeks, repeated every 4 months. In the pivotal trial that meant 6 series over 24 months, or 54 total treatments, and labeling notes no data supporting more than 54 treatments per eye. Each session takes under 5 minutes per eye, with no dilation, no anesthesia, and no injections, which matters because the burden is the number of visits rather than the visit itself.
Co-Management And What Comes Back
Referral for a photobiomodulation evaluation is not a transfer of care. Routine refraction, comprehensive examination, ocular surface care, glaucoma care, and cataract care stay with the referring practice throughout.
A report follows the candidacy visit and states the decision and the reason it was reached, with the acuity, the drusen and atrophy grading against the indication criteria, and the baseline imaging. A clear "not a candidate, and here is why" letter carries the same value as an acceptance.
There is no published co-management standard for retinal photobiomodulation, so any reporting cadence is practice convention rather than guidance. The reporting interval during a treatment series is agreed with the referring practice at the time of referral, and any conversion to wet AMD, atrophy reaching the center, or acuity falling outside the band is communicated immediately.
Urgency, And Who You Are Sending To
A dry AMD referral is routine. New distortion, a new central scotoma, or a sudden drop in acuity is neovascular disease until proven otherwise, and that is a same-day call to any office rather than a photobiomodulation referral. New England Retina Associates handles retinal emergencies and accommodates urgent cases; wet macular degeneration is managed with anti-VEGF therapy.
- A retina-only specialty practice since 1995
- Three fellowship-trained vitreoretinal surgeons
- An on-site two-year vitreoretinal surgery fellowship program
- NERA physicians hold appointments at Yale New Haven Hospital and other regional medical centers
- Active clinical research across multiple retinal disease categories
- More than 2,000 five-star reviews across the practice
Refer A Patient
Send the Vitreo-Retinal Consult Order Form to the office nearest your practice, or call to discuss a case with a physician before you send it.
Questions Patients And Providers Ask
Is This A Cure For Macular Degeneration?
No. Photobiomodulation is not a cure for dry AMD, and it does not replace anti-VEGF therapy for wet AMD. It does not bring back vision that has already been lost, and dry AMD can still progress during treatment. What the pivotal trial measured was a modest average acuity gain and fewer treated eyes developing new atrophy over the study period. Results vary by individual, and your doctor will recommend the best approach for your specific condition. More background sits on the dry macular degeneration page.
Is It Covered By Insurance?
Coverage varies, and it is not established. Photobiomodulation of the retina is billed under CPT Category III code 0936T, effective January 1, 2025. The Centers for Medicare and Medicaid Services did not assign a payment amount to that code in the 2025 Medicare Physician Fee Schedule, so Medicare Administrative Contractors decide claims case by case.
Commercial payers had not published formal coverage policies as of late 2025. It is also not exclusively a cash-pay procedure; it is sometimes covered and claims are paid. Medicare patients should be given an Advance Beneficiary Notice because coverage is not assured. Contact your nearest office to have your specific benefits checked before you start.
How Much Does It Cost?
No figure is published here, because there is no reliable one to publish. Since Medicare has assigned no payment amount to the code and contractors decide claim by claim, what a patient owes depends on the plan, the contractor, and the number of sessions. Ask for a written estimate before the first session, and expect to be asked to sign a form, such as an Advance Beneficiary Notice, acknowledging that payment is not assured.
Does It Hurt?
Most patients describe the treatment as comfortable. There is no dilation, no anesthesia, and no injection, and nothing touches the eye. In the pivotal trial the only device-related adverse events were dry eye, three cases. Some people notice a brief afterimage, similar to the spot left after a camera flash. Tell the technician about any discomfort during a session rather than waiting until it is over.
Is It Safe Long Term?
The controlled safety record is reassuring but it is not unlimited. Ocular adverse events occurred in 22.3% of study eyes, with no single event above 5%; only 4 were treatment-related, all mild to moderate, and none led anyone to stop. No signs of phototoxicity were observed over 24 months. That is a two-year controlled window within the studied dose and schedule, and no data supports more than 54 total treatments per eye. The evidence base is early and still developing.
How Will I Know If It Is Working?
Vision is formally measured before and after each treatment series, so the first objective checkpoint is the examination after the first nine sessions, and retinal imaging is compared over time. Be prepared for "working" to mean holding steady rather than seeing better: the labeled effect is approximately one line of ETDRS acuity at about two years compared with untreated eyes. Day-to-day vision fluctuates for reasons that have nothing to do with treatment, so a single good or bad day is not the measure. Results vary by individual.
What If It Does Not Work For Me?
Not every eye responds, and we say so plainly. At 13 months, 55.0% of treated eyes gained five or more letters versus 40.8% of sham eyes, and 26.4% gained ten or more versus 14.9%, which means a substantial minority of treated eyes did not gain a full line. Improvement is not assured, and dry AMD may still progress. If there is no response, stopping is discussed openly, and the rest of the plan continues: monitoring, supplement guidance where appropriate, and referral to low vision services if and when they would help.
Can I Stop After One Series?
You can stop at any time, and you should know what stopping means. Labeling states that treatment benefit may not persist significantly after treatment is stopped. The studied protocol is a series of nine sessions delivered three times a week over three to five weeks, repeated every four months, which came to six series and 54 treatments over two years in the pivotal trial. Treat it as an ongoing therapy, roughly three series a year, rather than a course you finish.
Do I Still Take My AREDS2 Supplements?
Yes, unless your doctor tells you otherwise. Light therapy is an addition to dry AMD care, not a replacement for it, and it is not a cure. The pivotal trial was run in patients who were largely already taking AMD supplements, so its results describe light therapy added to an existing plan. Supplement guidance, diet, smoking cessation, and home monitoring are covered on the dry macular degeneration page.
My Other Eye Has Wet AMD. Can I Still Have This?
Possibly, and it changes the conversation. Wet AMD in one eye raises the risk that the other eye converts too, and in the pivotal trial conversion to wet AMD occurred in 5.4% of treated eyes versus 1.8% of sham eyes at 13 months, with no p-value reported and no causal claim made by any source. If this is your situation, that risk is discussed specifically and monitoring is kept close. Light therapy does not treat the wet eye; that eye continues on anti-VEGF injections. Call the same day if you notice sudden central vision change, new distortion, or a new dark spot.
For referring providers
Provider Question: What Is The Actual Effect Size?
The labeled effect is approximately one line of ETDRS acuity at about two years versus untreated eyes. At 13 months, treated eyes gained an average of 5.4 letters versus 3.0 letters in the sham group (P = 0.02). A 2024 meta-analysis of the three randomized trials, 247 eyes, put the pooled gain at 1.76 ETDRS letters, below the 6.8-letter minimal clinically important difference the authors used, and rated all three trials at high risk of bias. Any within-arm figure quoted elsewhere is not the sham-controlled treatment effect and should not be read as one.
Provider Question: Does It Delay Geographic Atrophy?
The signal is real and it is not confirmatory. New geographic atrophy occurred in 1.1% of treated eyes, 1 of 87, versus 10.0% of sham eyes, 5 of 50, at 13 months (P = 0.024, odds ratio 9.4), and progression to atrophy at 24 months was 6.8% of treated eyes versus 24.0% of sham eyes (P = 0.007), a 71.7% relative reduction. Note what this is: new atrophy appearing, on very small event counts. Growth of lesions that already existed was not significantly different at 13 months, and drusen volume change was not significantly different either. Read it as a post-hoc signal awaiting a prospective test. More on atrophy sits on the dry macular degeneration page.
Provider Question: Do I Keep Managing The Patient?
Yes. Referral for a photobiomodulation evaluation is not a transfer of care. Routine refraction, comprehensive examination, ocular surface, glaucoma, and cataract care stay with the referring practice. The treating retina practice owns the candidacy decision, the treatment series, the associated imaging, and surveillance for conversion during the treatment arc. There is no published co-management standard for this therapy, so the reporting interval is agreed at the time of referral rather than assumed. Details are in the referring-provider block above, and on the for referring doctors page.
Provider Question: Should I Refer My 20/25 Patient With Large Drusen Now?
No, on two grounds. The authorized indication starts at 20/32, and better-than-20/32 acuity falls outside it, so a 20/25 eye is off-label however textbook the drusen look. Separately, according to Alcon labeling, patients with early-stage AMD showed minimal benefit at Month 24, a between-group difference versus sham of about +0.29 letters. Keep that patient on supplement guidance if appropriate, on home monitoring, and on your normal recall, and refer when measured acuity enters the band.
Access And Next Steps
Patients from New Haven, Bridgeport, Greenwich, and communities across Fairfield and New Haven counties are seen at any of NERA's four Connecticut offices.
Candidacy for photobiomodulation is confirmed by examination and retinal imaging, not by self-assessment, and results vary by individual.
Getting started takes three steps. First, call the office nearest you or ask your optometrist to send a referral. Second, a dilated evaluation with retinal imaging confirms whether the eye qualifies. Third, ask for a written benefits check before the first series begins.
If you notice a sudden change in central vision, new distortion, or a new dark spot, call the same day.
Dry macular degeneration overview All retina treatments For referring doctors