LumiThera Secures $2.3M NIH Grant for Dry AMD Trial

LumiThera has been granted a small business innovative research (SBIR) phase 2 grant from the National Institute of Health (NIH), totaling up to $2.3 million in funding over a span of 2 years.

This NIH/NEI grant is geared towards supporting an open-label human clinical trial in subjects with intermediate dry age-related macular degeneration (AMD) in the United States, including those who participated in the LIGHTSITE 3 trial. The LIGHTSITE 3B extension trial involves four rounds of treatment administered over a 14-month period. Notably, patients who previously received sham treatment in the earlier study will have the opportunity to switch and commence PBM treatment.

The LIGHTSITE 3B extension trial builds upon the outcomes of the completed LIGHTSITE 3 trial, which revealed a sustained, mean increase in best-corrected visual acuity (BCVA) letter score exceeding 5.0 letters from the baseline at the 13- and 24-month checkpoints (P < 0.0001), using LumiThera's Valeda Light Delivery System.

The study further showcased the advantages of slowing disease progression, as fewer eyes treated with PBM advanced to new geographic atrophy (GA). Optical coherence tomography (OCT) imaging of the retina at the 24-month mark indicated that only 6.8% of the PBM group experienced new GA progression, while the sham group witnessed new GA development in 24% of cases.

“Currently approved dry AMD treatments are limited to costly, invasive intravitreal injections targeting end stage disease that are not able to improve or sustain vision, unlike the results in the LIGHTSITE 3 trial,” Eleonora Lad, MD, PhD, Vice-chair of Ophthalmology Clinical Research at Duke University School of Medicine, said in a company news release. “The centers that participated in the LIGHTSITE 3 trial have reached out to study participants and received an overwhelming patient response to continue with the PBM treatments for an additional year. This is a testimonial about the potential impact of PBM for intermediate dry AMD patients.”

“The LIGHTSITE 3 patients that received the sham treatment continued to show disease progression. The open label study design will now follow the sham patients after receiving treatments and will continue to follow the PBM-treated patients for another year,” said David Boyer, MD, Retina-Vitreous Associates Medical Group, Los Angeles. “The ability to continue to treat and monitor these patients for another year should add to the knowledge and exciting results of sustaining vision and slowing disease progression as seen during the LIGHTSITE 3 trial.”