The FDA has approved LumiThera's Valeda Light Delivery System, a photobiomodulation (PBM) system, as the first treatment for dry age-related macular degeneration (AMD). This marks a significant advancement, offering a non-invasive option to improve vision in early-stage patients. The approval is based on the LIGHTSITE III trial, which demonstrated clinically meaningful improvements in visual acuity.
Mechanism of Action
The Valeda Light Delivery System uses specific wavelengths of light to stimulate and enhance the function of retinal mitochondria. This photobiomodulation aims to improve cellular metabolism and reduce oxidative stress, factors implicated in the pathogenesis of dry AMD. Unlike existing treatments that focus on slowing the progression of geographic atrophy (GA), this system targets vision improvement.
LIGHTSITE III Trial Results
The LIGHTSITE III trial was a phase III study involving 100 patients aged 50 and older with best corrected visual acuity (BCVA) between 20/32 and 20/100. Participants were randomized 2:1 to either PBM treatment or a sham procedure involving modified light application. Treatments were administered every 3 to 5 weeks over a 20-month period. The primary endpoint was the difference in BCVA at 24 months.
Data analysis, including 144 treated eyes, revealed a statistically significant improvement in vision starting at 9 months in the PBM group (P < 0.001). Approximately 60% of patients in the PBM arm experienced a greater than 5-letter gain in BCVA, with a mean improvement of 8.5 letters. Furthermore, almost 20% achieved a greater than 10-letter improvement (13.4 letters), and 5.5% had a greater than 15-letter gain (16.6 letters). At 24 months, new-onset GA was observed in 24% of the sham group compared to only 6.8% in the PBM group (P = 0.007).
Clinical Implications
Richard Rosen, MD, of the Icahn School of Medicine at Mount Sinai, noted that while existing FDA-approved drugs like pegcetacoplan injection (Syfovre) and avacincaptad pegol (Izervay) slow GA progression, they do not improve vision. He emphasized that the PBM system is intended for patients with early AMD who are just beginning to experience vision loss. "[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."
David Boyer, MD, of Retina Vitreous Associates Medical Group, expressed enthusiasm about the new treatment option, stating, "Patients will now be able to try a non-invasive treatment that can help improve their vision earlier in the disease process... This is an exciting option for patients and something doctors and patients have been waiting for."
