Valeda Photobiomodulation Referral Form - RCSD
Refer Your Patient for Valeda Light Therapy
Retina Consultants San Diego is proud to be the first practice in San Diego County to offer Valeda Light Therapy, the first and only FDA-authorized treatment for dry age-related macular degeneration shown to improve vision.
We are currently treating patients at our Poway office and expect to begin treating patients at our Carlsbad and La Jolla offices by mid-June. Use the form below to refer a patient for candidacy evaluation.
About Valeda Light Therapy
Valeda is a multiwavelength photobiomodulation treatment that delivers non-coherent light at 590 nm, 660 nm, and 850 nm. These wavelengths are intended to act on mitochondrial photoacceptors, including cytochrome c oxidase, to support cellular energy production and retinal cellular health.
The Valeda Light Delivery System is FDA-authorized to provide improved visual acuity in patients with best-corrected visual acuity of 20/32 through 20/70 who have dry AMD characterized by at least 3 medium drusen, large drusen, or non-central geographic atrophy, and no neovascular maculopathy or center-involving geographic atrophy. After about two years, treatment provides improved mean visual acuity of approximately one ETDRS line compared with those not receiving treatment.
Each treatment is brief and office-based, does not require dilation, anesthesia, injections, or recovery time, and is delivered by trained eyecare personnel under physician supervision. Device treatment time is 250 seconds per eye, or just over 4 minutes per eye.
Mechanism of Action
Photobiomodulation is thought to work through mitochondrial stimulation, particularly at the level of cytochrome c oxidase within the electron transport chain. Valeda’s wavelengths are intended to enhance electron transport and adenosine triphosphate production, supporting metabolically active retinal cells in a disease state associated with mitochondrial dysfunction.
According to manufacturer materials, the 590 nm wavelength is associated with nitric oxide signaling and vasodilation, while the 660 nm and 850 nm wavelengths are associated with increased metabolic activity and inhibition of inflammation- and cell death-related pathways. Referral and patient counseling should remain focused on the authorized indication and clinical outcomes.
Clinical Trial Data
LIGHTSITE III pivotal study
The key clinical evidence supporting FDA authorization comes from the LIGHTSITE III trial, a prospective, multicenter, double-masked, sham-controlled, randomized study conducted in patients age 50 and older with dry AMD. Subjects were randomized in a 2:1 ratio to active photobiomodulation or sham treatment, and eligible eyes received the assigned treatment over a 24-month study period.
The study enrolled 100 subjects and evaluated 148 eyes in the safety population, with 98 subjects and 145 eyes commonly cited in efficacy summaries. Eligible study eyes had ETDRS BCVA letter scores corresponding approximately to Snellen 20/100 to 20/32 at screening, although the FDA-authorized indicated population is narrower at 20/32 through 20/70.
The prespecified primary efficacy analysis evaluated mean change in best corrected visual acuity from baseline to Month 13 or Month 21. The study did not meet statistical significance at Month 13, where the active arm was 2.6 letters better than sham with p=0.0548, but it did meet the predetermined primary efficacy endpoint at Month 21, where the active arm was 3.8 letters better than sham with p=0.0036 and a 95% confidence interval of 1.2 to 6.3 letters.
Within-group analysis of treated eyes showed a mean gain of more than 5 ETDRS letters from baseline, including 6.0 letters at Month 13, 6.2 letters at Month 21, and 5.6 letters at Month 24. Manufacturer summaries further report that 84% of treated patients improved or maintained vision at about 2 years compared with baseline, and that more than 60% experienced at least a 1-line visual improvement at about 2 years.
No significant between-group difference was observed in low-luminance BCVA, Mars contrast sensitivity, macular drusen volume, or central subfield drusen thickness at the key analysis time points. The strongest evidence currently supports visual acuity benefit, while structural and other functional endpoints remain less clearly differentiated.
Patient Selection
Appropriate referral candidates
Consider referring patients with the following features:
- Best corrected visual acuity between 20/32 and 20/70.
- Dry AMD characterized by at least 3 medium drusen, large drusen, or non-central geographic atrophy.
- No evidence of neovascular maculopathy, including wet AMD or CNV.
- No center-involving geographic atrophy within the central 1 mm.
- Sufficient media clarity and ocular status to allow reliable imaging and visual assessment.
- Interest in a non-invasive, office-based treatment option and willingness to comply with a repeated treatment schedule.
Patients already taking or being considered for AREDS2 supplementation may still be appropriate for referral, but AREDS2 use is supportive background management rather than a formal requirement for treatment candidacy.
Contraindications and Precautions
Patients should not be treated with Valeda if they have known photosensitivity to yellow, red, or near-infrared light, or a history of light-activated central nervous system disorders such as epilepsy or migraine. Treatment should also be avoided within 30 days of use of photosensitizing agents affected by 590 nm, 660 nm, or 850 nm light unless cleared by the treating physician.
Safety and effectiveness have not been established in patients with current or prior neovascular maculopathy, center-involving geographic atrophy, visually significant cataract or posterior capsule opacification affecting assessment, ocular disease obstructing the pupil, or other clinically significant ocular pathology unrelated to dry AMD. Final determination of candidacy should be made after retinal evaluation by an RCSD physician.
Treatment Overview
Treatment protocol
- Initial course: 9 treatments over 3 to 5 weeks
- Interval: Approximately 4 months off treatment
- Second course: Repeat 9-treatment series over 3 to 5 weeks
- Interval: Approximately 4 months off treatment
- Third course: Repeat 9-treatment series over 3 to 5 weeks
Recommended duration: Treatment continued on this schedule for about 2 years for maximum benefit.
- Session duration: Approximately 4 minutes of device time per eye at each visit
- Recovery: No dilation, no injections, and no post-treatment recovery time; patients may resume normal activities immediately
For practical referral counseling, patients can be told that the treatment schedule is front-loaded and requires commitment, but each visit is brief and non-invasive. This can be especially appealing for patients who are motivated to pursue treatment but wish to avoid injection-based therapy.
Safety Profile
No phototoxicity or treatment-related serious adverse events were reported in manufacturer summaries across the LIGHTSITE program. In the FDA review, ocular adverse events were reported at similar overall rates between sham and PBM-treated eyes, and most were mild to moderate in severity.
In LIGHTSITE III, ocular-specific serious adverse events included neovascular AMD in both groups, with 7 cases reported in the PBM group and 2 in the sham group. One case of cystoid macular edema was reported in the sham group. No serious adverse events were considered related to treatment by the primary investigators.
Three procedure-related ocular adverse events were noted in the study: punctate keratitis in sham-treated eyes, visual perseveration or afterimage in one sham-treated subject, and application-site warmth in one PBM-treated subject. One non-ocular headache in the PBM group was considered possibly related to the device. No ocular adverse events led to study discontinuation.
What Referring Providers Should Know
Valeda is best thought of as a retina-directed treatment option for selected dry AMD patients who fall within a specific visual acuity and phenotype window. It is not a blanket treatment for all dry AMD, and it is not indicated for eyes with wet AMD, center-involving GA, or patients outside the studied population without careful individualized consideration.
The most clinically defensible way to discuss Valeda with patients and referring providers is to emphasize that it is the first FDA-authorized treatment for dry AMD shown to improve visual acuity in appropriately selected patients, while also acknowledging that benefit is modest on average, depends on repeated treatment, and should be weighed alongside individual risk factors and retinal findings.
Referral Guidance
Please refer patients for retinal evaluation if they appear to meet the indicated visual acuity range and clinical phenotype for treatment. Final candidacy will be determined after examination and imaging review by an RCSD retinal physician.
If helpful, referring providers may include recent OCT, fundus photography, autofluorescence, best corrected visual acuity, and relevant history regarding prior or fellow-eye neovascular disease. This can help streamline candidacy assessment and scheduling.