CRANBURY, N.J. - Palatin Technologies (NYSE:PTN), Inc. (NYSE American: PTN) has announced that its PL9643 treatment met the primary symptom endpoint in the MELODY-1 pivotal Phase 3 clinical trial for dry eye disease (DED). The trial showed that PL9643 was effective in reducing patient symptoms, specifically pain, and demonstrated an excellent safety and tolerability profile.
The study, which enrolled 575 patients across the U.S., was designed to assess the efficacy and safety of PL9643, a melanocortin agonist, compared to a vehicle (placebo) over a 12-week treatment period. It included two co-primary efficacy endpoints: a symptom (pain) and a sign (conjunctival lissamine green staining) of DED, along with multiple secondary endpoints.
After adjusting for age and gender in the intent-to-treat analysis, PL9643 demonstrated a clinically meaningful reduction in pain with statistical significance (p<0.025). However, the treatment did not meet the co-primary sign endpoint and secondary sign endpoints' statistical significance.
Carl Spana, Ph.D., President and CEO of Palatin, noted the rarity for a single clinical study in DED to show efficacy for both a sign and a symptom. He expressed satisfaction with the treatment's performance and stated that further analysis is underway. Plans to discuss the next pivotal Phase 3 clinical trial with the FDA are also in progress.
The safety analysis revealed fewer ocular treatment-related adverse events and study discontinuations in the PL9643 arm compared to the vehicle. The results suggest PL9643 could address a significant unmet medical need for an effective DED treatment.
DED is one of the most common ocular disorders in the U.S., affecting an estimated 38 million people, but remains largely undiagnosed and untreated with prescription products. Palatin's findings could potentially offer a new solution for those suffering from this condition.
The company will host a conference call today at 8:30 a.m. ET to discuss the trial results in greater detail. This article is based on a press release statement from Palatin Technologies.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.