Palatin: FDA confirms acceptability of Phase 3 pivotal clinical trials for PL964

Palatin Technologies announced receipt of FDA correspondence confirming the acceptability of the protocols and endpoints for signs and symptoms of PL9643 Phase 3 pivotal clinical trials for dry eye disease. The remaining Phase 3 clinical trial program consists of two Phase 3 studies, MELODY-2 and MELODY-3, and include sign and symptom endpoints in each study. Patient enrollment in MELODY-2 and MELODY-3 are currently expected to begin in the fourth quarter of calendar year 2024, resulting in topline results available by year-end calendar 2025. If recruitment goals are met and the trial results are successful, an NDA submission in the first half of calendar year 2026 would be anticipated.