Research & Development
Palatin Technologies completes enrolment of subjects in PL9643 MELODY-1 Phase three dry eye disease study
8 September 2023 -

Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company, announced on Thursday that it has completed enrolment of subjects in the PL9643 MELODY-1 Phase three study for dry eye disease (DED).

The company has enrolled a total of 570 subjects in the study. It is on track to reveal its topline outcome by the end of the fourth quarter of 2023. If the study reveals positive results, the remaining Phase three studies are likely to be completed by the end of 2024. The company would then submit a New Drug Application to the US Food and Drug Administration (FDA) for approval by mid 2025.

The Phase three MELODY-1 clinical study is carried out in the United States and is a multi-centre, randomised, double-masked and vehicle-controlled study that will assess the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution.

Carl Spana, PhD., president and CEO of Palatin, said, 'We are committed to addressing unmet needs of DED patients. We believe that PL9643, with its novel mechanism of action and differentiated product profile for efficacy, safety and ocular tolerability, if approved, will be a first-in-class treatment option for the millions of patients who suffer from DED. We are optimistic about results of the Phase 3 PL9643 data based on the positive interim analysis and are pleased to have completed enrolment so promptly. I thank the patients, investigators, clinical site staff, and our employees for achieving this important milestone.'