Palatin Presents Breakthrough Symptom Resolution Data from Phase 3 PL9643 MELODY-1 Clinical Trial in Dry Eye Disease at ARVO 2025
- Complete symptom resolution achieved across multiple endpoints - unprecedented in DED treatments
- 6 of 13 symptom endpoints reached statistical significance (p<0.05)
- Rapid onset of action from week 2, with continued improvement through week 12
- Strong safety profile with adverse events comparable to or better than vehicle
- Addresses large market opportunity with 38 million DED patients in U.S.
- Meets FDA 2020 approval guidance requirements
- Additional funding and partnership required for MELODY-2 and MELODY-3 trials
- Lengthy timeline to potential approval with topline data not expected until H2 2026
- Trading on OTC Pink market rather than major exchange
Insights
PL9643 shows breakthrough complete symptom resolution in dry eye disease Phase 3 trial; future development depends on securing partnerships.
The Phase 3 MELODY-1 results for Palatin's PL9643 represent a potential paradigm shift in dry eye disease treatment. What's truly remarkable is the complete symptom resolution across multiple endpoints - something not achieved by any currently approved therapy. Six of 13 symptom endpoints reached statistical significance (p<0.05) for complete resolution, with the co-primary endpoint of pain also meeting significance (p<0.025).
The rapid onset of action (beginning at week 2) and continued improvement through week 12 without plateau demonstrates a sustained therapeutic effect. From a mechanistic perspective, targeting the melanocortin receptor system represents a novel approach, activating natural resolution pathways rather than merely suppressing inflammation.
The objective improvement in ocular surface health through various staining measures suggests PL9643 may provide protective effects beyond symptom relief. This combination of subjective and objective improvements aligns perfectly with FDA's 2020 guidance supporting approval based on responder analyses showing statistically significant symptom resolution.
However, the development pathway still requires completion of two additional Phase 3 studies (MELODY-2 and MELODY-3). The explicit dependency on securing partnership and funding for these trials introduces uncertainty to the timeline. With enrollment potentially beginning in H2 2025 and data expected in H2 2026, we're looking at a minimum 2-year path to potential regulatory submission.
The DED market represents a substantial opportunity - affecting 38 million Americans with fewer than 10&percent; receiving prescription treatment. The projected market growth from
Updated Phase 3 analysis highlights PL9643 as a potential first-in-class treatment achieving full symptom resolution.
- Responder analyses demonstrate statistically significant symptom resolution across multiple endpoints in PL9643-treated patients compared to placebo.
- 6 of 13 symptom endpoints reached statistical significance (p<0.05).
- This level of symptom clearing has not been demonstrated by any currently approved dry eye disease therapy.
- Symptom resolution was observed as early as two weeks and continued through week 12 without plateau.
- PL9643 significantly improved clinical signs for staining measures, indicating potential to protect the ocular surface.
- PL9643 was well tolerated, with adverse event rates comparable to or better than vehicle.
The findings further strengthen PL9643's clinical profile and highlight its potential to address a critical unmet need by achieving levels of symptom relief not observed with existing therapies.
The poster, titled "Efficacy and safety of PL9643 in participants with dry eye disease: results from a phase 3, randomized, vehicle-controlled study," was presented by George Ousler, MS, of Ora, Inc. The full poster is available at www.palatin.com.
"This is breakthrough-level data," said Carl Spana, Ph.D., President and CEO of Palatin. "PL9643 is the first investigational therapy to demonstrate complete symptom resolution across multiple endpoints, with rapid onset and excellent tolerability. These results support a highly differentiated profile in the DED treatment landscape."
Clinical Data Presented:
- PL9643 showed statistically significant symptom improvement at week 2, continuing through week 12.
- 6 of 13 symptom endpoints reached statistical significance for complete resolution.
- Symptom Composite Score (average of seven VAS metrics) improved significantly at week 2 and continued to improve through week 12.
- PL9643 improved ocular surface health, including total, inferior, and corneal staining.
- Safety data showed PL9643 was well tolerated, with a profile similar to or better than vehicle (vehicle similar to artificial tears).
"The consistency and strength of these data, including full symptom resolution in a significant portion of patients, underscore PL9643's potential to fill a major therapeutic gap," said Michael Raizman, M.D., Chief Medical Officer of Palatin. "Combined with a robust safety profile, these results position PL9643 as a potential first-in-class DED treatment."
Regulatory Relevance:
FDA 2020 approval guidance supports the use of responder analyses that demonstrates statistically significant increases in the proportion of patients achieving complete symptom resolution as a basis for approval. PL9643 meets this threshold across multiple endpoints.
Phase 3 MELODY-1 PL9643 Design:
Palatin successfully completed MELODY-1, its first Phase 3 study, last year. The co-primary symptom endpoint of pain met statistical significance (P<0.025), and 7 secondary symptom endpoints met statistical significance (P<0.05), at the 12-week treatment period. 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
Next Steps in the Phase 3 PL9643 Program:
The remaining Phase 3 program includes two additional studies, MELODY-2 and MELODY-3, which will evaluate both signs and symptoms of DED. Pending partnership and funding, enrollment could begin in the second half of 2025, with topline data anticipated in the second half of 2026.
DED Market Opportunity:
DED affects approximately 38 million people in the
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 System
The melanocortin receptor (MCR) system plays a critical role in regulating inflammation, immune response, and tissue repair. MCR agonists have shown promise in restoring tissue homeostasis in ocular, gastrointestinal, and renal diseases. By activating natural resolution pathways, PL9588 and other melanocortin agonists represent a new class of anti-inflammatory, neuroprotective therapeutics.
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 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 Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release.
Palatin Technologies® is a registered trademark of Palatin Technologies, Inc.
View original content to download multimedia:https://www.prnewswire.com/news-releases/palatin-presents-breakthrough-symptom-resolution-data-from-phase-3-pl9643-melody-1-clinical-trial-in-dry-eye-disease-at-arvo-2025-302450611.html
SOURCE Palatin Technologies, Inc.
FAQ
What are the key findings from Palatin's (PTN) Phase 3 MELODY-1 trial for dry eye disease?
When will Palatin (PTN) complete the MELODY-2 and MELODY-3 trials for PL9643?
What is the market size for dry eye disease treatment that Palatin's PL9643 targets?
How does Palatin's PL9643 differ from existing dry eye disease treatments?
What are the safety results for Palatin's PL9643 in dry eye disease treatment?
