Galimedix Therapeutics announced the initiation of a Phase 2 study (eDREAM; NCT06659549) with GAL-101 eyedrops in patients with dry AMD. The randomized, double-blind, placebo-controlled multicenter study will evaluate the efficacy and safety of GAL-101 eyedrops in patients with geographic atrophy, the company said in a press release.  

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. 

“We are excited to start this trial, which was designed in collaboration with leading global experts in AMD. GAL-101 eyedrops 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,” said Hermann Russ, MD, PhD, Co-founder and CSO of Galimedix, in the company press release. “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.”