PL9643 Fails Key Phase III Endpoints in Dry Eye Study

Palatin Technologies, a New Jersey company, recently reported that its drug candidate PL9643 for dry eye disease (DED) did not fully meet the goals of a critical late-stage clinical trial known as Melody-1. The Phase III trial was designed to assess the safety and effectiveness of the melanocortin agonist PL9643, with two primary endpoints: one focusing on a clinical symptom (pain) and the other on a clinical sign (conjunctival lissamine green staining), along with additional secondary endpoints.
The company indicated that PL9643 demonstrated a significant reduction in pain with a p-value below 0.025, suggesting a positive treatment effect. However, the drug did not achieve statistical significance for the primary sign endpoint or the secondary sign endpoints in the initial analysis. Despite this, Palatin's CEO, Carl Spana, emphasized the rarity of a single study showing efficacy for both a symptom and a sign in DED and highlighted the ongoing additional analyses to further evaluate the drug's potential.
Palatin is planning to engage with the FDA to discuss the findings and seek guidance for the next phase of clinical trials. The company also expressed satisfaction with the drug's safety profile and its impact on reducing certain symptoms. The remaining Phase III trial components, including further efficacy assessments and open label studies, are expected to commence patient enrollment in the latter half of 2024.
In the competitive landscape for DED treatments, Palatin faces competition from Alcon, which reported positive results from its clinical trials for the drug candidate AR-15512 in January 2024. Additionally, the FDA has already approved Miebo, a perfluorohexyloctane ophthalmic solution developed by Bausch + Lomb and Novaliq, for the treatment of symptoms associated with tear evaporation in dry eye disease.