Biopharmaceutical company Palatin Technologies Inc (OTC PINK:PTNT) on Thursday presented new data from the Phase 3 MELODY-1 study at the 2025 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.
Palatin said that the updated responder analyses highlight PL9643's rapid onset of action, broad and statistically significant efficacy, and complete symptom resolution across multiple endpoints in patients with dry eye disease (DED).
The findings further strengthen PL9643's clinical profile and highlight its potential to address a critical unmet need by achieving levels of symptom relief not observed with existing therapies.
Palatin successfully completed MELODY-1, its first Phase 3 study, last year. The multi-centre, randomised, double-masked and vehicle-controlled study enrolled 575 patients at sites in the Unites States. It evaluated the safety and efficacy of the melanocortin agonist PL9643 ophthalmic solution after treatment for 12 weeks, compared to placebo, in patients with moderate-to-severe DED, for multiple sign and symptom endpoints. Safety analysis from the trial indicated PL9643 was well-tolerated.
The remaining Phase 3 programme includes two additional studies, MELODY-2 and MELODY-3, which will evaluate both signs and symptoms of DED. Pending partnership and funding, enrolment could begin in the second half of 2025, with topline data anticipated in the second half of 2026.
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