The FDA announcement marketing authorization for a form of light therapy as the first treatment for dry age-related macular degeneration (AMD).

LumiThera’s Valeda Light Delivery System generates light at different wavelengths to stimulate and improve the function of retinal mitochondria. The photobiomodulation (PBM) system is the first treatment demonstrated to improve vision loss associated with dry AMD.

“Patients will now be able to try a noninvasive treatment that can help them improve their vision earlier in the disease process,” said David Boyer, MD, of Retina Vitreous Associates Medical Group in Beverly Hills, Calif., in a study. company statement. “This is an exciting option for patients and something that doctors and patients have been waiting for.”

The FDA has already approved two drugs: Pegcetacoplan injection (Syfovre) And avacincaptad pegol (Izervay) — to treat geographic atrophy (GA) secondary to dry AMD.

The medications slow the progression of GA but do not improve vision, noted Richard Rosen, MD, of the Icahn School of Medicine at Mount Sinai in New York. PBM is intended for early AMD and phase III LUMIER III SITE In this trial, the therapy led to an improvement in vision of approximately one line of ETDRS (Early Treatment of Diabetic Retinopathy Study) letters.

“(The PBM system) is intended for the early stages of the disease, for patients who are just starting to lose their vision, who have Drusenand the vision is maybe down a line or two,” Rosen said Page Med today. “(The treatment) has been shown to improve vision in the majority of treated patients. There has never been a drug for dry AMD that has improved vision.”

The LIGHTSITE III trial included 100 patients aged 50 and over with best corrected visual acuity (BCVA) between 20/32 and 20/100. They were randomized in a 2:1 ratio using a PBM or sham procedure involving modified light application. Patients received treatment every 3 to 5 weeks for 20 months, and the primary endpoint was the difference in BCVA at 24 months.

Analysis of data on 144 treated eyes showed a statistically significant difference in vision from 9 months in favor of PBM (P.<0,001). Près de 60 % des patients affectés au PBM présentaient un gain de BCVA > 5 letters (mean 8.5), almost 20% had an improvement > 10 letters (13.4) and 5.5% had a gain > 15 letters (16.6). . At 24 months, 12 of 50 (24%) patients in the sham group had new onset GA, compared with six (6.8%) in the PBM group (P.=0.007).