OKYO Pharma Achieves Successful FDA Meeting on Urcosimod
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2d ago
0mins
Source: Newsfilter
- 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.
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Analyst Views on OKYO
Wall Street analysts forecast OKYO stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for OKYO is 6.00 USD with a low forecast of 5.00 USD and a high forecast of 7.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 2.040
Low
5.00
Averages
6.00
High
7.00
Current: 2.040
Low
5.00
Averages
6.00
High
7.00
About OKYO
OKYO Pharma Limited is a United Kingdom-based clinical-stage biopharmaceutical company developing therapies for the treatment of dry eye disease (DED) and neuropathic corneal pain (NCP). The Company is focused on the discovery and development of novel molecules to treat neuropathic corneal pain and dry eye disease. Its research program focuses on a novel G Protein-Coupled Receptor (GPCR). The Company’s lead candidate, urcosimod, is a non-steroidal anti-inflammatory and non-opioid analgesic. Urcosimod consists of a 10-mer C-terminal Chemerin sequence, a linker (PEG-8), and Palmitic acid. It has completed a Phase II trial in patients with DED and NCP. The Company also plans to evaluate its potential in benefiting patients with ocular neuropathic pain, uveitis and allergic conjunctivitis. It is also evaluating OK-201, a bovine adrenal medulla (BAM), lipidated-peptide preclinical analogue candidate that is in the developmental stage.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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.
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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.
Continue Reading