Palatin Offers Hope to 20 Million Americans with Treatment for Dry Eye Disease

Biopharmaceutical company, Palatin Technologies, Inc. (NYSE American: PTN), has presented positive topline results from 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).

Palatin’s study demonstrated clinically meaningful and statistically significant results, including excellent safety and tolerability, and rapid onset of efficacy.

“Analysis of our successful Phase 3 MELODY-1 clinical trial results demonstrate that PL9643 has broad, robust and rapid efficacy for multiple symptom endpoints,” said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin.

“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,” concluded Dr. Spana.

Palatin expected to discuss PL9643’s regulatory approval path with the FDA in the second quarter of 2024.

DED is a common inflammatory disease that can become extremely painful and lead to permanent damage to the cornea and vision. It affects approximately 20 million Americans and 344 million people worldwide. The company’s Phase 3 MELODY-1 trial was a multi-center, randomized, double–masked and vehicle–controlled study that enrolled 575 patients at sites in the US.

About Palatin

Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin’s strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. To learn more about Palatin, please visit us on www.Palatin.com and follow us on Twitter at @PalatinTech.