ONL1204 Ophthalmic Solution in Patients With Geographic Atrophy Associated With Age-related Macular Degeneration
Status:
Recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the safety and tolerability of intravitreal
injection of ONL1204 Ophthalmic Solution in patients with geographic atrophy associated with
AMD.
GA associated with AMD is one of the world's leading causes of visual disability. It is a
progressive disease with no approved therapy to slow or arrest the process of continual
photoreceptor and retinal epithelial (RPE) cell loss. A safe and effective therapy for GA
will have vast societal benefits. ONL1204 is being developed for this purpose. ONL1204 is a
first-in-class inhibitor of fragment apoptosis stimulator receptor-mediated cell death in
development for to reduce rates of vision in patients with GA associated with AMD. ONL1204
has demonstrated protection of multiple retinal cell types in several preclinical models of
acute ocular injury and the protection of RPE in AMD models. ONL1204 Ophthalmic Solution is
currently in a Phase 1 clinical study in patients with macula-off retinal detachment to
evaluate safety and tolerability of a single-dose of ONL1204 Ophthalmic Solution. The study
is ongoing and uses the same doses and route of administration as this Phase 1b study in
patients with GA.