FDA Grants Market Authorization to Light-Therapy System for Dry AMD

The FDA announced marketing authorization of a form of light therapy as the first-ever 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 shown to improve vision loss associated with dry AMD.

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

The FDA has previously approved two drugs — pegcetacoplan injection (Syfovre) and avacincaptad pegol (Izervay) — to treat geographic atrophy (GA) secondary to dry AMD.

The drugs slow GA progression but do not improve vision, noted Richard Rosen, MD, of the Icahn School of Medicine at Mount Sinai in New York City. PBM is for early AMD, and in the phase III LIGHTSITE III trial, the therapy led to vision improvement that averaged about one line of ETDRS (Early Treatment of Diabetic Retinopathy Study) letters.

“[The PBM system] is for early disease, patients who are just starting to lose vision, who have some drusen, and the vision is down maybe a line or two,” Rosen told MedPage Today. “[The treatment] was shown to improve the vision in the majority of patients who were treated. There has never been a drug for dry AMD that improved the vision.”

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

Data analysis that included 144 treated eyes showed a statistically significant difference in vision beginning at 9 months in favor of PBM (P5-letter gain in BCVA (mean of 8.5), almost 20% had a >10-letter improvement (13.4), and 5.5% had a >15-letter gain (16.6). At 24 months, 12 of 50 (24%) patients in the sham group had new-onset GA as compared with six (6.8%) in the PBM arm (P=0.007).