The National Institutes of Health (NIH) and National Eye Institute (NEI) have awarded LumiThera Inc. a small business innovative research (SBIR) phase 2 grant for the continued study of dry age-related macular degeneration (AMD).
Let’s start with this company.
Headquartered in Poulsbo, Washington, LumiThera is a medical device company targeting the diagnosis, treatment, and monitoring of ocular disease and dry AMD.
The company’s lead product is the Valeda Light Delivery System (LDS), which uses multiwavelength photobiomodulation (PBM) to treat dry AMD patients.
To note, this system is not FDA approved in the United States.
Now the grant.
The Phase 2 SBIR grant is part of the SBIR and Small Business Technology Transfer (STTR) programs that encourage U.S.-based small businesses to engage in federal research / research and development with the potential for commercialization via collaboration with a research institution.
The SBIR grant intended to provide funding for a small business to continue research and development of a specific technology.
Subsequently, a company may only submit one application for this grant. If rejected, the company is unable to resubmit.
How much is it for?
Per LumiThera, up to $2.3 million in funding over a 2-year period.
Gotcha. And what is it supporting?
The launch of LIGHTSITE IIIB, an open-label human clinical trial that will assess intermediate dry AMD in patients who participated in the pivotal LIGHTSITE III (NCT04065490) trial.
Wait, back up here. What happened with the LIGHTSITE I and II trials?
LIGHTSITE I (NCT02725762) and LIGHTSITE II (NCT03878420) assessed the use of PBM—via the Valeda LDS—as treatment for dry AMD.
Both studies demonstrated sustained improvements in visual benefits and concluded PBM could be considered a therapeutic treatment option for dry AMD.
Okay … and the LIGHTSITE III trial?
This trial (the most recent of the three), was a prospective, double-masked, sham-controlled, parallel group, randomized, multicenter trial enrolled 100 participants with early to intermediate dry AMD across 10 retinal centers in the United States.
Click here for our coverage on the study’s 24-month data, including input from LumiThera President and CEO Clark Tedford on the Valeda LDS.
What were the conclusions from this trial?
Investigators reported that the use of PBM as treatment resulted in a statistically significant slowing of disease progression in patients with early to intermediate dry AMD, including those who might suffer from new GA lesions.
Now discuss this LIGHTSITE IIIB trial extension.
According to Eleonora Lad, MD, PhD, vice-chair of Ophthalmology Clinical Research at Duke University School of Medicine. “The centers that participated in the LIGHTSITE III trial have reached out to study participants and received an overwhelming patient response to continue with the PBM treatments for an additional year.”
Patients will receive four rounds of treatment over a 14-month period along with those patients who previously received sham crossing over to receive PBM treatment.
When might data be available?
TBD at the moment. Stay tuned for clinical updates!