Palatin presents results from Phase 3 PL9643 MELODY-1 trial

Palatin (PTN) Technologies presented new data from the Phase 3 MELODY-1 study at the 2025 Association for Research in Vision and Ophthalmology Annual Meeting. The updated responder analyses highlight PL9643’s rapid onset of action, broad and statistically significant efficacy, and complete symptom resolution across multiple endpoints in patients with dry eye disease. “This is breakthrough-level data,” said Carl Spana, Ph.D., President and CEO of Palatin. “PL9643 is the first investigational therapy to demonstrate complete symptom resolution across multiple endpoints, with rapid onset and excellent tolerability. These results support a highly differentiated profile in the DED treatment landscape.” Clinical Data Presented: PL9643 showed statistically significant symptom improvement at week 2, continuing through week 12. 6 of 13 symptom endpoints reached statistical significance for complete resolution. Symptom Composite Score improved significantly at week 2 and continued to improve through week 12. PL9643 improved ocular surface health, including total, inferior, and corneal staining. Safety data showed PL9643 was well tolerated, with a profile similar to or better than vehicle (vehicle similar to artificial tears). “The consistency and strength of these data, including full symptom resolution in a significant portion of patients, underscore PL9643’s potential to fill a major therapeutic gap,” said Michael Raizman, M.D., Chief Medical Officer of Palatin. “Combined with a robust safety profile, these results position PL9643 as a potential first-in-class DED treatment.”