Palatin presents results from Phase 3 PL9643 MELODY-1 trial

Palatin Technologies 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 at the American Society of Cataract and Refractive Surgery. The presentation by Dr. Eric Donnenfeld, entitled “Updates, What’s New in Treatment, What’s New and on the Threshold of FDA Approval” was presented on Friday, April 5th, at the ASCRS Conference in Boston, Massachusetts. Dr. Donnenfeld’s presentation included MELODY-1 Phase 3 clinical data results, which indicate that the Intent-to-Treat PL9643 treatment population demonstrated clinically meaningful and statistically significant results at the change from baseline to week 12 for the co-primary symptom endpoint of pain and multiple exploratory secondary symptom endpoints. The presentation also included an overview of the excellent and superior safety and tolerability profile of PL9643 compared to other approved treatments. “Analysis of our successful Phase 3 MELODY-1 clinical trial results, demonstrate that PL9643 has broad, robust and rapid efficacy for multiple symptom endpoints. The efficacy results were statistically significant for the co-primary symptom endpoint of pain and 7 of 11 exploratory secondary endpoints, including eye dryness, as early as two weeks (the 1st time point measured). The effect improved and maintained statistical significance over the 12-week treatment period,” said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. “Additionally, we have identified a substantial patient population with statistically significant efficacy results after two weeks of treatment with PL9643 for multiple sign endpoints, including all four fluorescein staining endpoints, which improves ocular surface disorders and facilitates the identification and treatment of epithelial damage and corneal injuries.” “The early onset of efficacy for multiple symptoms and signs of dry eye disease and the excellent ocular safety and tolerability profile positions PL9643 as a highly differentiated product. We are advancing discussions with potential collaboration partners and actively preparing for a meeting with the FDA later this quarter to discuss the remaining studies for the PL9643 program required to support an NDA submission,” Dr. Spana continued. “Dr. Donnenfeld’s presentation is important, not only because it illustrates PL9643 MELODY-1 positive results in the context of other developmental programs for DED but identifies a potential key differentiating treatment option for dry eye disease in terms of its safety and tolerability profile,” commented Michael Raizman, M.D., Chief Medical Officer at Palatin. 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 compared to vehicle, and fewer study discontinuations in the PL9643 arm compared to vehicle. A higher proportion of the vehicle-treated patients dropped out of the study prior to week 12 compared to the PL9643-treated patients.