LumiThera Receives NIH Grant to Support Dry AMD Trial
LumiThera announced it is a recipient of a small business innovative research (SBIR) phase 2 grant from the National Institute of Health (NIH) of up to $2.3 million in funding over 2 years.
The NIH/NEI grant supports an open-label human clinical trial in intermediate dry age-related macular degeneration (AMD) subjects in the US that participated in the LIGHTSITE 3 trial. LIGHTSITE 3B will treat patients for 4 rounds of treatment over 14 months. Sham patients in the previous study will be able to cross over and begin PBM treatment.
The LIGHTSITE 3B extension trial follows the completed LIGHTSITE 3 trial, which showed a sustained, mean increase in best corrected vision acuity (BCVA) letter score of >5.0 letters from baseline at the 13- and 24-month timepoints (P < 0.0001) using the company’s Valeda Light Delivery System. The study demonstrated disease slowing benefits as fewer PBM-treated eyes progressed to new geographic atrophy (GA). The 24-month optical coherence tomography (OCT) imaging of the retina indicated that only 6.8% of the PBM group had progressed to new GA, whereas 24% in the sham group developed new GA.
“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.”