LumiThera Inc. has received marketing authorization from the US Food & Drug Administration (FDA) for its Valeda Light Delivery System, a pioneering treatment for patients suffering from vision loss due to dry age-related macular degeneration (AMD). This marks the first time the FDA has authorized a treatment for vision loss associated with dry AMD.
The authorization was based on clinical data from the LIGHTSITE III trial (NCT04065490), a prospective, double-masked, randomized, multi-center study conducted at 10 US retinal centers. The trial enrolled 100 subjects with early to intermediate dry AMD and demonstrated that Valeda met its primary endpoint, showing both safety and effectiveness in improving and maintaining visual acuity.
LIGHTSITE III Trial Results
The LIGHTSITE III trial's analysis included 91 eyes in the photobiomodulation (PBM) treatment group and 54 eyes in the sham-treatment group. The trial initially demonstrated a sustained and statistically significant improvement in best-corrected visual acuity (BCVA) at 13 months in the PBM treatment group compared to the sham group (p = 0.02). Subsequent data revealed a sustained, mean increase in ETDRS letter score >5.0 letters from baseline at both the 13- and 21-month timepoints in the PBM-treated subjects BCVA (p < 0.0001).
At 24 months, the improvement from baseline in BCVA in the PBM treatment group was significantly greater than in the sham group, with a difference of 5.9 letters vs 1.0 letters (p = 0.0015). Approximately 58% of the PBM-treated eyes had >5 letter gain, with a mean gain of 8.5 + 0.5 letters.
Expert Commentary
Glenn Jaffe, MD, Duke Reading Center, commented on the trial results, stating, "The primary endpoint for the study was visual acuity gain. We also followed multiple anatomical endpoints from BL throughout the 24-month study to determine whether photobiomodulation [PBM] helped to preserve retinal anatomy. The PBM treatment had a beneficial effect on multiple anatomic biomarkers. For example, we looked at whether PBM affected progression to geographic atrophy and found that incident geographic atrophy was reduced in the PBM-treated eyes compared to the sham treated eyes respectively, 6.8% versus 24%. Although incident GA was not a prespecified clinical endpoint, the results supported overall safety benefits of treating earlier in dry AMD disease."
Regulatory Context
Lori Holder, vice president, regulatory affairs, at LumiThera, Inc., noted, "The De Novo authorization established Valeda as the first device for treatment of dry AMD patients with vision loss and creates a threshold for this novel class of PBM devices that must show similar clinical and nonclinical performance controls equivalent to the Valeda Light Delivery System."
Valeda is CE Marked in the EU and is available in select countries in Latin America.
