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 (DED). 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, the company said in a press release.

According to Palatin, patient enrollment in MELODY-2 and MELODY-3 are 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, the company says an NDA submission in the first half of calendar year 2026 would be anticipated.

Palatin successfully completed MELODY-1, its first Phase 3 study, in February 2024. The co-primary symptom endpoint of pain met statistical significance (P<0.025) and 7 of 11 secondary symptom endpoints met statistical significance (P<0.05), at the 12-week treatment period. Data from MELODY-1 demonstrated a rapid onset of efficacy and multiple symptom endpoints, including the co-primary pain endpoint, which met statistical significance (P<0.05) at the 2-week timepoint and continued to improve over the 12-week treatment period. Also, at the 2-week timepoint, multiple sign endpoints, including all four fluorescein staining endpoints, met statistical significance (P<0.05). Importantly, PL9643 treatment demonstrated an excellent safety and tolerability profile, the company said.