FDA Approves Palatin's Final Phase 3 Trials for PL9643 in Dry Eye Disease

Palatin Technologies, Inc., a biopharmaceutical innovator specializing in medicines that influence the melanocortin receptor system, has received positive feedback from the FDA regarding the protocols and endpoints for the final Phase 3 clinical trials of their therapeutic candidate, PL9643, for dry eye disease (DED). The FDA's endorsement pertains specifically to the MELODY-2 and MELODY-3 pivotal trials. These clinical trials will focus on assessing both the signs and symptoms of DED, a prevalent and often debilitating condition characterized by insufficient moisture and lubrication of the eye surface.

Carl Spana, Ph.D., President and CEO of Palatin, expressed satisfaction with the FDA's concurrence on the trial protocols. He emphasized the inadequacy of current prescription treatments for DED, which are frequently criticized by both patients and eye care professionals for their unsatisfactory efficacy, delayed action, and poor tolerability. He highlighted PL9643's promise due to its rapid onset of efficacy for both signs and symptoms, coupled with an excellent safety and tolerability profile. This places PL9643 in a unique position to potentially address the unmet needs of millions suffering from DED.

Patient recruitment for the MELODY-2 and MELODY-3 trials is anticipated to begin in the fourth quarter of 2024, with topline results expected by the end of 2025. Should these trials meet their recruitment and efficacy goals, Palatin aims to submit a New Drug Application (NDA) in the first half of 2026.

Palatin's prior success with MELODY-1, the initial Phase 3 study completed in February 2024, set a positive precedent. The trial's co-primary symptom endpoint of pain achieved statistical significance, along with 7 out of 11 secondary symptom endpoints, within the 12-week treatment period. The data highlighted PL9643's rapid onset of efficacy, particularly for the co-primary pain endpoint, which showed significant improvement as early as the 2-week mark and continued to progress throughout the 12 weeks. Additionally, multiple sign endpoints, specifically all four fluorescein staining endpoints, met statistical significance at the 2-week mark, underscoring the treatment's potential.

Dry eye disease affects the cornea and conjunctiva, leading to symptoms such as irritation, redness, pain, and blurred vision. The condition results from inadequate moisture and lubrication on the eye's surface, causing inflammation and discomfort, which can severely impact quality of life and, in extreme cases, cause permanent vision damage. Current treatments often take months to show effectiveness and are generally considered inadequate by healthcare providers and patients alike.

DED is one of the most common eye disorders, impacting about 38 million adults in the United States and approximately 719 million globally. While traditionally associated with aging populations, the prevalence of DED has surged across all ages and genders, partly driven by increased digital screen use.

Palatin's research focuses on melanocortin receptor agonists, which can modulate inflammatory responses, immune functions, metabolism, and other critical biological processes. The company leverages this system, targeting various receptors, to develop therapies with significant clinical potential. Their strategic approach includes forming partnerships with industry leaders to maximize the commercial success of their products.

In summary, Palatin Technologies is progressing toward offering a new, potentially more effective treatment for dry eye disease with PL9643. With the support of the FDA, the company is poised to advance through the final stages of clinical trials, hoping to bring much-needed relief to DED sufferers worldwide.