OKYO Pharma Holds Meeting with FDA, Confirms Urcosimod Clinical Trial Plan
OKYO Pharma held a Type C meeting with the Food & Drug Administration regarding the Phase 2b/3 human clinical trial of urcosimod for the treatment of neuropathic corneal pain. Key highlights from the Type C FDA meeting include: FDA confirms the approach that the proposed primary endpoint of the Visual Analogue Scale pain reduction at Week 12 is clinically meaningful, including explicit acknowledgment that a greater than or equal to2-point improvement on the VAS scale represents a meaningful treatment effect. The Agency provided statistical guidance to enhance robustness, noting that if the statistical analysis plan is finalized prior to unmasking and results are strong, the data could provide substantial evidence of effectiveness at a future End-of-Phase 2b/3 meeting. FDA endorsed the proposed study design, sample size, and powering assumptions, and agreed that the Ocular Pain Assessment Survey is appropriate as supportive quality-of-life evidence. FDA alignment on the Chemistry, Manufacturing and Controls strategy and key clinical elements, with no material issues raised, derisking the pathway to a pivotal trial and supports potential registration if study results are robust. As previously communicated, urcosimod was granted the first IND to treat patients with NCP and was awarded fast track designation by the Food and Drug Administration. The company expects to initiate a 120-patient Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.
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OKYO Pharma to Present Urcosimod Data at ASCRS Meeting
- Key Conference Presentation: OKYO Pharma's lead candidate urcosimod has been accepted for presentation at the 2026 American Society of Cataract and Refractive Surgery Annual Meeting, highlighting its potential in treating neuropathic corneal pain and likely attracting significant attention from ophthalmology experts.
- Clinical Trial Results: Urcosimod demonstrated significant pain reduction and improvements in corneal nerve health in a recently completed Phase 2 trial, providing robust clinical data that may enhance its acceptance and usage in the market.
- Future Research Plans: The company plans to initiate a 150-patient Phase 2b/3 multiple-dose study in the first half of 2026 to further validate urcosimod's efficacy, paving the way for commercialization and addressing the urgent market need for effective treatments.
- FDA Fast Track Designation: Urcosimod has received FDA fast track designation as the first IND drug for neuropathic corneal pain, showcasing its innovation in the treatment space and potential for significant commercial opportunities for the company.
OKYO Pharma Achieves Successful FDA Meeting on Urcosimod
- FDA Meeting Outcomes: OKYO Pharma's Type C meeting with the FDA confirmed the clinical development plan for urcosimod in treating neuropathic corneal pain, with the FDA recognizing a ≥2-point improvement on the VAS scale as a meaningful treatment effect, indicating significant market potential for the drug.
- Statistical Guidance Support: The FDA provided guidance on the statistical analysis plan, emphasizing that if finalized before unmasking and results are strong, it could provide substantial evidence of effectiveness at a future End-of-Phase 2b/3 meeting, thereby de-risking the clinical trial pathway.
- Study Design Endorsement: The FDA endorsed the study design, sample size, and powering assumptions for urcosimod, and agreed that the Ocular Pain Assessment Survey is appropriate as supportive quality-of-life evidence, further enhancing the credibility of the clinical trial.
- Future Research Plans: OKYO plans to initiate a 120-patient Phase 2b/3 multiple-dose study in the first half of 2026, aiming to address the significant unmet medical need in neuropathic corneal pain treatment, thereby advancing the company's strategic development in the biopharmaceutical sector.