Palatin Technologies, Inc. announced that enrollment in the PL9643 MELODY-1 Phase 3 study in dry eye disease (DED) is complete, with 570 patients enrolled. The Company is on track to release topline results by the end of the fourth quarter of calendar year 2023. Palatin previously announced positive interim analysis data and recently presented portions of this data at the ARVO 2023 conference in April 2023.

The excellent ocular tolerability and efficacy across multiple signs and symptoms of DED distinguishes PL9643 from currently approved treatments for DED. Topline data for the PL9643 MELODY-1 Phase 3 Study is anticipated by the end of the fourth quarter of calendar year 2023. Assuming positive results, the remaining Phase 3 studies are expected to be completed by the end of calendar year 2024 and early calendar year 2025, with a New Drug Application submission to the U.S. Food and Drug Administration (FDA) for approval mid-year calendar 2025.

The pivotal Phase 3 MELODY-1 clinical study, being conducted in the U.S., is a multi-center, randomized, double masked and vehicle controlled study evaluating the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution, compared to vehicle in patients with moderate-to-severe DED, for multiple sign and symptom endpoints. The study design is based on positive Phase 2 results of PL9643 for the treatment of DED, and an end-of-phase 2 meeting with the FDA on key elements of the pivotal Phase 3 clinical program. Dry eye disease is a common inflammatory disease that, left untreated, can become extremely painful and lead to permanent damage to the cornea and vision.

DED affects the cornea and conjunctiva of the eye resulting in irritation, redness, pain, and blurred vision. It is estimated to affect over 20 million people in the United States. The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment.

Existing therapy for DED is generally regarded as inadequate by many physicians and patients, and often requires weeks or months to demonstrate activity. The melanocortin receptor (MCr) system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1r through MC5r.

Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects. Many tissues and immune cells located throughout the body, including the gut, kidney and eye, express melanocortin receptors, empowering opportunity to directly activate natural pathways to resolve disease inflammation. Drugs based on melanocortin agonists have been approved by the FDA for treating several conditions, including female sexual dysfunction, inflammatory/autoimmune diseases, and rare forms of genetic obesity.