OKYO Pharma is making significant strides in addressing the unmet medical need for neuropathic corneal pain (NCP) treatment, with its novel drug candidate OK-101 advancing through clinical development. The company announced plans to complete enrollment for its groundbreaking Phase 2a trial by the end of the second quarter of 2025, with top-line data expected in Q4 2025.
First-in-Class Treatment for Neuropathic Corneal Pain
OK-101 represents a pioneering approach as the first drug candidate to receive FDA clearance for clinical evaluation specifically targeting NCP. This non-opioid therapeutic aims to alleviate the debilitating pain associated with corneal nerve damage, a condition that currently lacks FDA-approved treatments. The condition commonly stems from dry eye disease, surgical procedures, or infections, significantly impacting patients' quality of life.
The Phase 2a trial design incorporates rigorous patient selection criteria, including confirmation of NCP through confocal microscopy, patient symptom assessment, and detailed medical histories. The study's double-masked, randomized, placebo-controlled structure over 12 weeks will evaluate the drug's efficacy in 48 patients.
Expert Leadership and Trial Management
The trial is being conducted under the leadership of Dr. Pedram Hamrah at Tufts Medical Center, a globally recognized authority in NCP treatment. Dr. Hamrah, who serves as Professor and Vice Chair of Research and Academic Programs, brings extensive expertise in ocular pain management and has contributed to developing new diagnostic markers through in vivo confocal microscopy.
Promising Results in Dry Eye Disease
Parallel to its NCP program, OKYO Pharma has demonstrated encouraging results in its dry eye disease (DED) program. The Phase 2b trial of OK-101 for DED showed statistically significant improvements in multiple endpoints:
- Total conjunctival staining showed improvement by Day 29 (p = 0.034)
- Burning/stinging symptoms improved as early as Day 15 (p = 0.04)
- Blurred vision showed significant improvement by Day 29 (p = 0.01)
The safety profile was particularly noteworthy, with treatment-emergent adverse events comparable to placebo, and no severe drug-related ocular adverse events reported among the 240 treated patients.
Market Potential and Development Strategy
The development of OK-101 targets two significant market opportunities: the untapped NCP market and the multi-billion-dollar DED market. Following the positive Phase 2b results in DED, OKYO plans to engage with the FDA to outline future clinical development strategies.
The company maintains a strong focus on advancing both programs, with the NCP trial results anticipated to be a crucial milestone. This dual-program approach positions OKYO Pharma to potentially address significant unmet needs in ocular health, particularly for patients suffering from chronic pain conditions.
