FDA confirms acceptability of remaining phase III pivotal clinical trials for PL 9643 in dry eye disease (DED)
Palatin Technologies, Inc. announced receipt of FDA correspondence confirming the acceptability of the protocols and endpoints for signs and symptoms of PL 9643 Phase III pivotal clinical trials for dry eye disease (DED)
The remaining Phase III clinical trial program consists of two Phase III studies, MELODY-2 and MELODY-3, and include sign and symptom endpoints in each study.
“We are pleased to have concluded a positive Type C meeting with the FDA and agreement on the remaining two Phase III trial protocols, including the sign and symptom endpoints, for PL 9643 for the treatment of patients with DED,” said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. “Current prescription options for DED are generally regarded as inadequate by many eye care professionals and patients due to low treatment efficacy, slow onset of action and/or poor tolerability. PL 9643, with its early onset of efficacy for both signs and symptoms, and its excellent ocular safety and tolerability profile, is positioned as a highly differentiated product with an opportunity to bring relief to millions of dry eye sufferers.”
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.
Palatin successfully completed MELODY-1, its first Phase III 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 4 fluorescein staining endpoints, met statistical significance (p><0.05). importantly, pl 9643 treatment demonstrated an excellent safety and tolerability profile.>
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.