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Patient enrollment completed for clinical study to treat dry AMD


Investigators are studying the use of photobiomodulation in the treatment of dry age-related macular degeneration.

LumiThera Inc. announced that it has completed enrollment in its multi-center United States clinical study in non-neovascular (dry) Age-Related Macular Degeneration (AMD) patients.

The randomly assigned, multi-center study, LIGHTSITE III, enrolled the last patient at the Byers Eye Institute at Stanford University in Palo Alto, CA with principal investigator, Diana Do, MD.

“We are very pleased to be able to enroll the last subject in the Study,” Dr. Do said in a statement. “Initial efficacy data will be available in approximately 13 months. The study will continue to follow patients for up to 24 months."

LIGHTSITE III, using a light delivery system (Valeda Light Delivery System, LumiThera Inc.), is a FDA, IDE-approved prospective, randomly assigned, double-masked trial being conducted in ten leading retinal centers throughout the United States. The study enrolled 100 patients suffering from dry AMD and will treat and follow patients over the course of two years. In addition to demonstrating safety, key efficacy endpoints include visual acuity, contrast sensitivity and reduction of drusen deposits.

The National Institute of Health and division of the National Eye Institute provided a $2.5M grant to partially support the U.S. study. 

“It is exciting to be involved in a potential new treatment for dry AMD patients," Allen Hu, MD, principal investigator, Cumberland Valley Retina Consultants, said in a statement. “Our experience to date in the trial with the Valeda system has been very encouraging."

LumiThera obtained a CE mark to commercialize the light delivery system in the European Union for the treatment of ocular damage and disease including dry AMD. The LIGHTSITE II post-marketing study with top retinal centers in key European countries was recently completed with limited enrollment due to COVID-19 and will provide results later this year.

"Our commercial experience with Valeda to date in Europe has been positive," Rene Ruckert, MD, MBA, acting chief medical officer, said in a statement. "I have been involved in both Eylea and Lucentis drugs for neovascular (wet) AMD and to be involved in a novel, noninvasive treatment for dry AMD is very exciting."

Cindy Croissant, MBA, vice president, Clinical Operations at LumiThera, noted that it has been challenging to enroll patients in clinical trials during the COVID-19 pandemic.

“We are truly appreciative of the hard work all the centers have done to safely provide Valeda treatments to dry AMD patients in these studies,” she said. 

Clark Tedford, PhD, president and CEO of LumiThera, said in a statement that the data the company continues to accumulate from these trials will be used to further support our commercialization efforts and global regulatory submissions.

“We enlisted top retinal private and university centers in the United States for the LIGHTSITE III trial and if successful, the study should allow an important treatment choice in preventing vision loss for patients in the United States,” he said.

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