According to the company, the multicenter US study enrolled more than 900 subjects with moderate-to-severe dry eye disease with topline data anticipated in the second quarter of 2023.
Allysta Pharmaceuticals Inc. today announced that it has completed enrollment in its Phase 2b/3 trial (OASIS-1) of ALY688 Ophthalmic Solution for the treatment of dry eye disease.
According to the company, ALY688 Ophthalmic Solution contains ALY688, a novel first-in-class peptide with broad anti-inflammatory and corneal epithelial regenerative properties.
The OASIS-1 trial (NCT04899518) is a randomly assigned, double-masked, vehicle-controlled study of two concentrations of ALY688 Ophthalmic Solution vs vehicle administered twice daily for 12 weeks. This multi-center US study randomized 922 subjects with moderate-to-severe dry eye disease based upon signs (staining) and symptoms (patient-reported outcomes).
According to the news release, qualified subjects underwent a 2-week run-in period following which, if they continued to qualify, were randomized to one of 3 arms: ALY688 Ophthalmic Solution (0.4%), ALY688 Ophthalmic Solution (1%), or Vehicle Solution. Key endpoints are improvement in corneal staining and dry eye symptoms. Additional endpoints include improvement in conjunctival staining and tear volume (Schirmer's test).
"We are grateful to the OASIS-1 study investigators, coordinators, and dry eye patients whose dedication and commitment were instrumental in the successful completion of enrollment in this multicenter pivotal study," Kenneth Sall MD, Medical Head of Ophthalmology at Allysta, said in a press release.
The company anticipates that topline data will be announced in the second quarter of 2023.
About ALY688 Ophthalmic Solution
ALY688 Ophthalmic Solution is a novel sterile and preservative-free eye drop formulation containing ALY688 peptide, a novel first-in-class therapeutic with unique multi-modal mechanisms-of-action that include broad anti-inflammatory activity and enhancement of corneal and conjunctival epithelial regeneration.
In animal models of dry eye disease, ALY688 decreased inflammation on the ocular surface (both T cell and pro-inflammatory cytokines) and accelerated healing (re-epithelization) following corneal injury. By targeting multiple key pathways of dry eye pathogenesis, including chronic inflammation and ocular epithelial cell damage, ALY688 may offer greater success to a broad range of dry eye sufferers.
The OASIS-1 study follows upon a Phase 1/2a trial in dry eye subjects that showed dose-related improvements in a range of clinically relevant measures of dry eye signs and symptoms. These included improvements (compared with vehicle) in ocular surface staining (both corneal and conjunctival) and patient-reported symptom scales seen as early as two weeks after starting treatment. In addition, ALY688 Ophthalmic Solution was well tolerated with a low rate of post-instillation reactions, all mild and transient, with 100% of subjects completing the full dosing period.
ALY688 peptide is a potent specific adiponectin analogue that activates multiple adiponectin signaling pathways. Adiponectin is considered a unique "protective" cytokine due to its broad beneficial actions including reduction of inflammation (both at the cytokine and cellular levels) and enhancement of epithelial regeneration; it also demonstrates anti-fibrotic activity. In preclinical models, ALY688 reduced inflammation, cell injury, and fibrosis across a range of diseases, providing opportunities to develop ALY688 in multiple disease indications.