Phase 2b/3 trial to evaluate novel peptide formulation in dry eye
Patient dosing is underway in a phase 2b/3 trial investigating ALY688 ophthalmic solution for the treatment of dry eye disease, according to a press release from Allysta Pharmaceuticals.
Up to 900 subjects who have moderate to severe signs and symptoms of dry eye will be enrolled in the randomized, double-masked, vehicle-controlled, multicenter OASIS-1 trial. Two concentrations of ALY688 are under evaluation for efficacy and safety vs. vehicle administered twice daily for 12 weeks.
ALY688 ophthalmic solution is a novel formulation containing ALY688 peptide that targets chronic inflammation and ocular epithelial cell damage, the release said.
A phase 1/2a study demonstrated “dose-related improvements in a variety of clinically relevant measures of dry eye signs and symptoms,” including improvements in ocular surface staining and patient-reported symptom scales, the release said.
Allysta expects the study will take approximately 1 year.