Palatin Says Topline Results From The Phase 3 MELODY-1 Study Of PL9643 In Dry Eye Disease Positive

(RTTNews) - Biopharmaceutical company Palatin Technologies, Inc. (PTN) Monday said it presented positive topline results from the Phase 3 MELODY-1 study of its drug candidate PL9643 in dry eye disease at the American Society of Cataract and Refractive Surgery (ASCRS).

Phase 3 MELODY-1 study was to evaluate the safety and efficacy of PL9643 ophthalmic solution after treatment for 12 weeks, compared to vehicle in 575 patients with dry eye disease, for multiple sign and symptom endpoints.

Results from the study showed that 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. Safety analysis from the trial indicated PL9643 was well-tolerated.

"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," said Carl Spana, President and Chief Executive Officer of Palatin.