FDA Accepts Protocols and Endpoints for Phase III Trial of PL9643 in Dry Eye Disease

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Palatin has announced receipt of FDA’s acceptance of protocols and endpoints for signs and symptoms for a duo of Phase III trials evaluating PL9643, a melanocortin agonist, in patients with dry eye disease (DED). The studies, MEOLDY-2 and MELODY-3, are part of Palatin’s Phase III program for PL9643.¹

Enrollment for the trials is expected to start Q4 2024, with topline results expected by the end of 2025. If the trials meet their recruitment goals and results are positive, Palatin anticipates submitting a New Drug Application (NDA) in the first half of 2026.

"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 PL9643 for the treatment of patients with DED," Carl Spana, PhD, president and chief executive officer of Palatin said 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. 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."

Palatin shared results from the first Phase III study in this clinical program, MELODY-1, in February 2024. The trial had two co-primary efficacy endpoints, one clinical symptom (pain) and one clinical sign (conjunctival lissamine green staining). According to the results, 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.²

MEOLDY-1 was a multi-center, randomized, double–masked, and vehicle–controlled study that enrolled 575 patients in the US. It evaluated the safety and efficacy of PL9643 compared to vehicle in patients with moderate-to-severe DED.

In a press release from the time, Spana said, "Even with a high vehicle response, PL9643 treatment was clinically meaningful and statistically significantly effective on an ITT basis in reducing patient symptoms for the co-primary pain endpoint and multiple other symptom endpoints. We are pleased that PL9643 treatment demonstrated excellent safety and tolerability data, including superior efficacy results compared to vehicle across multiple sign endpoints."

References

1. FDA Confirms Acceptability of Palatin's Remaining Phase 3 Pivotal Clinical Trials for PL9643 in Dry Eye Disease (DED). News release. Palatin. August 28, 2024. Accessed August 28, 2024. https://www.prnewswire.com/news-releases/fda-confirms-acceptability-of-palatins-remaining-phase-3-pivotal-clinical-trials-for-pl9643-in-dry-eye-disease-ded-302232457.html#:~:text=(NYSE%20American%3A%20PTN)%2C,symptoms%20of%20PL9643%20Phase%203

2. Palatin Announces Results of PL9643 MELODY-1 Pivotal Phase 3 Clinical Trial in Patients with Dry Eye Disease (DED). News release. Palatin. February 28, 2024. Accessed August 28, 2024. https://www.prnewswire.com/news-releases/palatin-announces-results-of-pl9643-melody-1-pivotal-phase-3-clinical-trial-in-patients-with-dry-eye-disease-ded-302073599.html