Palatin Reports PL9643 Phase 3 Trial Results for Dry Eye Disease

Palatin Technologies, Inc., a biopharmaceutical company located in Cranbury, N.J., has reported significant results from its PL9643 MELODY-1 Phase 3 clinical trial. This trial aimed to evaluate the safety and efficacy of PL9643 in treating dry eye disease (DED) compared to a vehicle.

The MELODY-1 study assessed two primary endpoints: a symptom endpoint, specifically pain, and a sign endpoint involving conjunctival lissamine green staining, along with several secondary endpoints concerning both signs and symptoms of DED. Conducted over 12 weeks with an initial 4-week run-in period, the analysis considered patient age and gender, as 60% of participants were over 60 years old and 68% were female. When adjusting for these factors, PL9643 showed clinically significant results in reducing pain, as well as other symptom endpoints, with statistical significance (p<0.025).

However, the treatment did not meet statistical significance for the co-primary sign endpoint or secondary sign endpoints in the Intent-to-Treat (ITT) population. Despite an initially high vehicle response, these findings indicate PL9643's clinical effectiveness in alleviating DED symptoms. Dr. Carl Spana, President and CEO of Palatin, highlighted the excellent safety profile and superior efficacy of PL9643 over the vehicle in multiple sign endpoints.

Dr. Spana also noted the uniqueness of PL9643, as it is uncommon for a single clinical study in DED to show efficacy in both signs and symptoms. The comprehensive analysis is ongoing, and the company plans to discuss the future design of the next Phase 3 trial with the FDA. Palatin also continues to seek a collaborative partner for further development of their DED program.

Notably, PL9643 demonstrated favorable safety outcomes with fewer ocular adverse events (5.6%) and study discontinuations (7.0%) compared to the vehicle group (6.3% and 11.1%, respectively). This positions PL9643 as a promising therapeutic candidate for the millions suffering from DED in the U.S., where treatment is often inadequate, and many patients remain undiagnosed.

The MELODY-1 trial enrolled 575 patients across multiple U.S. centers in a randomized, double-masked, vehicle-controlled format. The study was grounded on positive Phase 2 results. Palatin plans to discuss detailed results in an upcoming conference call and webcast.

In summary, PL9643 shows significant promise for addressing unmet medical needs in dry eye disease, with substantial effectiveness in symptom reduction and a strong safety profile.