Galimedix Launches phase 2 trial of GAL-101 eye drops for Dry AMD

Galimedix Therapeutics, Inc , a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases, today announced the initiation of a Phase 2 study with GAL-101 eye drops in patients with dry age-related macular degeneration (dry AMD), a leading cause of adult blindness. The randomized, double-blind, placebo-controlled multicenter study will evaluate the efficacy and safety of GAL-101 eye drops in patients with geographic atrophy, an advanced form of dry AMD.

“We are excited to start this trial, which was designed in collaboration with leading global experts in AMD. GAL-101 eye drops have already shown an excellent safety and tolerability profile in Phase 1 clinical testing, and compelling efficacy with GAL-101 protecting neuronal retinal cells from toxic damage has been demonstrated in relevant ophthalmic pre-clinical models,” says Hermann Russ, MD, PhD, Co-founder and CSO of Galimedix. “Despite recent advances, there remains a need to offer patient-friendly, safe, and effective treatment options for this disease, and we look forward to seeing the results from this important trial.”

The Phase 2 study is planned to enroll up to 110 patients, who will be randomized 1:1 to receive study drug or placebo. The primary endpoint of the trial is reduction in rate of change of geographic atrophy lesion size. The trial will also evaluate the reduction in rate of change in the area of photoreceptor degeneration and various functional outcome measures, including retinal sensitivity on microperimetry with patient-tailored grid design.