FDA Confirms Acceptability of Palatin's Remaining Phase 3 Pivotal Clinical Trials for PL9643 in Dry Eye Disease (DED)
- FDA & Palatin agree on clear regulatory path for PL9643 NDA submission in DED
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FDA confirms acceptability of protocols and endpoints for remaining MELODY-2 & MELODY-3 Phase 3 Pivotal Clinical Trials in DED
- Currently anticipate patient enrollment to start in 4Q calendar year 2024
- Topline results currently expected in 4Q calendar year 2025
"We are pleased to have concluded a positive Type C meeting with the FDA and agreement on the remaining two Phase 3 trial protocols, including the sign and symptom endpoints, for PL9643 for the treatment of patients with DED," said
Patient enrollment in MELODY-2 and MELODY-3 are currently expected to begin in the fourth quarter of calendar year 2024, resulting in topline results available by year-end calendar 2025. If recruitment goals are met and the trial results are successful, an NDA submission in the first half of calendar year 2026 would be anticipated.
Palatin successfully completed MELODY-1, its first Phase 3 study, in
About Dry Eye Disease (DED)
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. 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 months to demonstrate activity.
Dry eye disease is one of the most common ocular surface disorders, affecting an estimated 38 million adults in
About Melanocortin Receptor Agonists and Inflammation
The melanocortin receptor ("MCR") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MCR1 through MCR5. 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 in the eye (and other places, like the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.
About Palatin
Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at www.Palatin.com and follow Palatin on Twitter at @PalatinTech.
Forward-looking Statements
Statements in this press release that are not historical facts, including statements about future expectations of
References
- Market Scope 2023 Dry Eye Product Market Review; does not include OTC artificial tears and other Rx anti-inflammatory and tear stimulants.
- The Relationship Between Dry Eye Disease and Digital Screen Use - PMC (nih.gov)
- Improved Dry Eye Drugs for 2022 and Beyond; https://www.aao.org/eye-health/tips-prevention/new-dry-eye-treatments-ocular-surface-disease
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