Palatin announces results from PL9643 MELODY-1 pivotal Phase 3 clinical trial

Palatin Technologies announced results for its PL9643 MELODY-1 pivotal Phase 3 clinical trial evaluating the safety and efficacy of PL9643 versus vehicle in the treatment of dry eye disease, or DED. MELODY-1 had two co-primary efficacy endpoints: one clinical symptom, pain, and one clinical sign, conjunctival lissamine green staining, as well as multiple other symptom and sign secondary endpoints of DED. Duration of treatment was 12 weeks with a 4-week run-in period. Analysis of the data indicated that both age and sex needed to be accounted for in the primary statistical analysis. After adjusting the Intent-to-Treat, or ITT, analysis for age and gender, PL9643 treatment demonstrated clinically meaningful and statistically significant results for the co-primary symptom endpoint of pain and multiple other symptom endpoints. PL9643 treatment for the co-primary sign endpoint and secondary sign endpoints demonstrated positive treatment effects over vehicle in the ITT population but did not achieve statistical significance. In the unadjusted planned analyses, the co-primary endpoints and secondary endpoints did not reach statistical significance. Safety analysis 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.