Allysta Pharmaceuticals, Inc. announced on Tuesday that it has completed patient enrollment in its phase 2b/3 (OASIS-1 trial) of ALY688 ophthalmic solution for treating dry eye disease (DED).
What is ALY688?
ALY688 is a novel first-in-class peptide with broad anti-inflammatory and corneal epithelial regenerative properties. It promotes a reduction in corneal damage and improvements in tear volume and integrity with proinflammatory cytokines and activated T cells on the ocular surface. (via)
Tell me about the study.
The OASIS-1 trial (NCT04899518) is a randomized, double-masked, and vehicle-controlled study evaluating the safety and efficacy of ALY688 ophthalmic solution (0.4%), ALY688 ophthalmic solution (1%), and a vehicle solution. Participants must administer the eye drop treatment twice daily for 12 weeks. (via)
Who was eligible for the study?
The multi-center US study has 922 participants with moderate-to-severe DED based on signs (staining) and symptoms (patient-reported outcomes).
Qualified subjects were required to have DED for longer than 3 months, meet specific sign and symptom criteria, and have a best-corrected visual acuity of +0.6 logMAR or better. Eligible participants then underwent a 2 week run-in period before being accepted into the study. (via)
What are the key endpoints of the study?
The primary key endpoints include improvements in corneal staining and dry eye symptoms; secondary endpoints include conjunctival staining and tear volume (Schirmer’s test). (via)
When can we expect results?
The topline data will be released in the second quarter of 2023.