Palatin announced database lock for Phase 3 trial of dry eye disease candidate

Palatin Technologies announced database lock for its PL9643 MELODY-1 pivotal Phase 3 clinical trial evaluating the safety and efficacy of PL9643 versus vehicle in the treatment of dry eye disease, or DED. MELODY-1 has two co-primary efficacy endpoints: one clinical sign of DED and one clinical symptom of DED. If one or both co-primary end points are met, the study will be deemed a success and the secondary end points will be evaluated using a hierarchical testing strategy. The trial evaluated the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution, compared to vehicle in patients with moderate-to-severe DED, for multiple sign and symptom endpoints, after treatment for 12 weeks. The remainder of the Phase 3 program, which includes the Phase 3 safety and efficacy study MELODY-2 and the open label MELODY-3 study are anticipated to commence patient enrollment in the second half of calendar year 2024.