First clinical results demonstrate efficacy of VOY-101, a novel gene therapy for GA

Clinicians and industry partners continue the race to find the most efficacious therapy for age-related macular degeneration (AMD). A new gene therapy may solve the puzzle for patients with non-neovascular AMD, and more information is coming soon from a Phase 2 trial, according to one retina researcher. Omer Trivizki, MD, MBA, a retina specialist from Tel Aviv Medical Center in Israel, shared details about VOY-101, a novel, complement-modulating gene therapy for geographic atrophy (GA).

The Eye Care Network caught up with Dr Trivizki at the American Society of Retina Specialists (ASRS) Annual Meeting in Long Beach, California. He explained the mechanisms beyind VOY-101( Perceive Biotherapeutics, Inc.) and the Phase 1 Beyond study (NCT06087458).

"In our talk, we showed that VOY-101 is safe and tolerable," Dr Trivizki recounted. A 12-month survey of 24 enrolled patients showed there was no dose limiting toxicity, no systemic adverse effects and no ocular adverse effects, he said. "There was a really mild, transient intraocular cell effect that we observed during the study, which passed with topical steroids only, and eventually all patients were off steroids with no recurrence," Dr Trivizki said. "That led us to the conclusion that we can move ahead to the Phase 2 [trial] which...[dosed the first patient in late June]."

Dr Trivizki went on to explain the mechanism of the treatment, which is designed to provide patients with Complement Factor H gene (CFH) protection. "CFH protection is a protein that was found to protect patients with GA," Dr Trivizki said. "The idea here is to provide, with one intravitreal injection, the protection effect of CFH...[and] to be able to use the eye as a production for this specific protein, so with a single injection, you can treat the patient for the long term."

Dr Trivizki explained that the Phase 1 trial had six sites across three countries, with most of the patients in Tel Aviv. The follow-up, Phase 2 trial, Journey, has started enrollment and dosing, and will follow patients to a 12-month primary endpoint, he added.