Palatin Technologies, Inc. announced the presentation of topline results for its Phase 3 PL9643 MELODY-1 pivotal clinical trial evaluating the safety and efficacy of PL9643 versus vehicle in the treatment of dry eye disease (DED) at the American Society of Cataract and Refractive Surgery (ASCRS). Safety analysis from the Phase 3 MELODY-1 trial indicated PL9643 was well-tolerated. There were fewer ocular treatment related adverse events in the PL9643 arm (5.6%, N=16/288) compared to vehicle (6.3%, N=18/287), and fewer study discontinuations in the PL9643 arm (7.0%, N=20/288) compared to vehicle (11.1%, N=32/287).

A higher proportion of the vehicle-treated patients dropped out of the study prior to week 12 compared to the PL9643-treated patients. The Phase 3 MELODY-1 trial was a multi-center, randomized, double?masked and vehicle?controlled study that enrolled 575 patients at sites in the U.S. The trial evaluated the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution after treatment for 12 weeks, compared to vehicle in patients with moderate-to-severe DED, for multiple sign and symptom endpoints. The study design was based on positive Phase 2 results of PL9643 for the treatment of DED, and an end-of-Phase 2 meeting with the FDA on key elements of the pivotal Phase 3 clinical program.