Palatin Announces Phase 3 PL9643 MELODY-1 Dry Eye Disease (DED) Clinical Data Results Presented at American Society of Cataract and Refractive Surgery (ASCRS) 2024
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Positive Phase 3 Study Results Included in Dr.
Eric Donnenfeld's Presentation- Co-Primary Symptom Endpoint of Pain Met Statistical Significance (P<0.025) and 7 of 11 Secondary Symptom Endpoints Met Statistical Significance (P<0.05), 12-Week Treatment Period
- Rapid Onset of Efficacy at the 2-Week Treatment Period , Multiple Symptom Endpoints, Including the Co-Primary Pain Endpoint, Met Statistical Significance and Continued to Improve Over the 12-Week Treatment Period
- At the 2-Week Treatment Period, Multiple Sign Endpoints, Including All 4 Fluorescein Staining Endpoints, Met Statistical Significance (P<0.05)
- Excellent Safety and Tolerability Profile
- Discussions with FDA on Regulatory Approval Path Planned for 2Q 2024
The presentation by Dr.
"Analysis of our successful Phase 3 MELODY-1 clinical trial results, demonstrate that PL9643 has broad, robust and rapid efficacy for multiple symptom endpoints. The efficacy results were statistically significant for the co-primary symptom endpoint of pain and 7 of 11 exploratory secondary endpoints, including eye dryness, as early as two weeks (the 1st time point measured). The effect improved and maintained statistical significance over the 12-week treatment period," said
"The early onset of efficacy for multiple symptoms and signs of dry eye disease and the excellent ocular safety and tolerability profile positions PL9643 as a highly differentiated product. We are advancing discussions with potential collaboration partners and actively preparing for a meeting with the FDA later this quarter to discuss the remaining studies for the PL9643 program required to support an NDA submission,"
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Safety analysis from the Phase 3 MELODY-1 trial indicated PL9643 was well-tolerated. There were fewer ocular treatment related adverse events in the PL9643 arm (5.6%, N=16/288) compared to vehicle (6.3%, N=18/287), and fewer study discontinuations in the PL9643 arm (7.0%, N=20/288) compared to vehicle (11.1%, N=32/287). A higher proportion of the vehicle-treated patients dropped out of the study prior to week 12 compared to the PL9643-treated patients.
The Phase 3 MELODY-1 trial was a multi-center, randomized, double–masked and vehicle–controlled study that enrolled 575 patients at sites in the
PL9643 represents an opportunity to bring relief to dry eye sufferers. While DED is one of the most common ocular disorders, affecting an estimated 38 million people in the
About the
The ASCRS Annual Meeting, focused on therapeutic, surgical, and administrative topics directly relevant to ASCRS and ASOA members, offers symposia, lectures, workshops, sessions, courses, and skills transfer labs to help anterior segment surgeons, practice managers, administrators, technicians, and nurses maintain and refine their skills.
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.
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. To learn more about Palatin, please visit us on www.Palatin.com and follow us on Twitter at @PalatinTech.
Forward-Looking Statements
Statements in this press release that are not historical facts, including statements about future expectations of
References
1. Market Scope 2023 Dry Eye Product Market Review; does not include OTC artificial tears and other Rx anti-inflammatory and tear stimulants.
2. Mordor Intelligence – Dry Eye Disease Market Size & Share Analysis – Growth Trends & Forecasts (2024-2029).
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