FDA accepts protocols, endpoints for remaining phase 3 trials on PL9643 for dry eye
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The FDA and Palatin Technologies have agreed on protocols and sign and symptom endpoints for the remaining phase 3 clinical trials of PL9643 for dry eye disease, the company announced in a press release.
“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,” Carl Spana, PhD, Palatin’s president and CEO, said in the release. “PL9643, 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.”
The remaining trials, MELODY-2 and MELODY-3, are expected to begin enrollment in the fourth quarter of 2024, with topline results available in 2025. The company anticipates an NDA submission in the first half of 2026, pending successful recruitment and trial results.
According to the release, MELODY-1, the first phase 3 trial, was successfully completed in February 2024, with PL9643 demonstrating rapid onset of efficacy and multiple symptom endpoints, including pain, which achieved statistical significance at week 2 and improved over 12 weeks of treatment. PL9643 also exhibited “excellent” safety and tolerability during the trial, the release stated.
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