Retinal PhysicianCan Photobiomodulation Regulate Dry AMD?

🎓 Expert Commentary / Peer Perspective

The Valeda Light Delivery System received FDA de novo authorization in November 2024 for PBM in dry AMD following LIGHTSITE III. Specialists are now weighing whether the evidence supports clinical adoption or warrants further study before integration into treatment paradigms.

Clinical Considerations

• LIGHTSITE III reported a 5.4-letter BCVA gain in PBM-treated eyes vs 3.0 letters in sham at 13 months (P=.02), with new GA occurring in 1 of 87 PBM-treated eyes vs 5 of 50 sham-treated eyes.
• BCVA naturally varies by up to 9 ETDRS letters over 3 months in untreated intermediate AMD eyes, larger than the LIGHTSITE III treatment effect, raising questions about whether gains reflect signal or noise.
• A trial sequential analysis estimated 555 eyes are needed for statistical inference on BCVA outcomes; all three PBM RCTs combined included only 241 eyes.
• Two of three meta-analyses rated included RCTs as high risk of bias under Cochrane RoB-2, with industry sponsorship and overlapping investigator-manufacturer involvement flagged.

Practice Applications

• Recognize that FDA de novo authorization is not equivalent to clinical validation of therapeutic benefit.
• Consider patient selection per LIGHTSITE III inclusion criteria: BCVA 20/30 to 20/70, qualifying drusen or noncentral GA, no choroidal neovascularization or central GA.
• Interpret reported anatomic findings (drusen morphology, choriocapillaris perfusion) as hypothesis-generating pending validation.
• Counsel patients that PBM may require ongoing treatment cycles with uncertain long-term durability.
• Avoid framing PBM as established standard of care while awaiting large, independent, high-quality RCTs with more sensitive endpoints than BCVA.