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OKYO Pharma Limited (NASDAQ: OKYO) is a clinical-stage biopharmaceutical company dedicated to developing groundbreaking therapies for inflammatory eye diseases and chronic pain conditions. The company is at the forefront of creating innovative treatments for Dry Eye Disease (DED) and Neuropathic Corneal Pain (NCP), both of which represent significant unmet medical needs in the ophthalmology sector.
One of OKYO Pharma's hallmark achievements is its development of the OK-101 ophthalmic solution. This drug candidate has shown promising results in pre-clinical studies, demonstrating dual-action anti-inflammatory and neuropathic corneal pain-reducing activities. The ongoing Phase 2 clinical trials are aimed at establishing the safety and efficacy of OK-101 in treating DED and NCP. Notably, these trials have successfully completed patient enrollment, with top-line results expected soon.
OKYO Pharma's approach leverages a unique membrane-anchored-peptide technology to ensure the prolonged presence of the drug in the ocular environment, thereby enhancing its therapeutic impact. In recent studies, OK-101 has exhibited statistically significant improvements in multiple dry eye-related symptoms, including stinging, burning, and blurred vision, as well as a notable reduction in conjunctival staining. These promising outcomes pave the way for future Phase 3 registration trials.
Financially, OKYO Pharma is well-positioned, with its ordinary shares listed on the NASDAQ Capital Market. The company continues to forge strategic partnerships and collaborations to bolster its research and development efforts. With a robust pipeline and a commitment to addressing the complex biology of eye diseases, OKYO Pharma stands as a pioneering entity in the biopharmaceutical landscape.
The latest developments include positive safety and efficacy results from the Phase 2 trials of OK-101, and the recent FDA clearance for OK-101's Investigational New Drug (IND) application for treating NCP. These milestones underscore the potential of OKYO Pharma's innovative solutions to significantly improve patient outcomes.
OKYO Pharma is set to begin a Phase 2 clinical trial of OK-101 for treating neuropathic corneal pain (NCP) in Q3 2024. This is the first instance of an FDA IND clearance for a drug targeting NCP, a significant unmet medical need. OK-101 has shown statistically significant pain relief in previous trials for dry eye disease and preclinical models of NCP. The 12-week, placebo-controlled trial will be led by Dr. Pedram Hamrah at Tufts Medical Center, involving 48 NCP patients. The study aims to measure pain improvement using a visual analogue scale (VAS).
CEO Dr. Gary S. Jacob emphasizes the potential of OK-101, highlighting its previous success in reducing pain in dry eye patients, some of whom suffer from NCP. The trial's design includes five study visits over 16 weeks, with pain improvement as the primary endpoint. Encouraging preclinical and clinical data support the trial's objectives. More details are available in the company's Form 6-K filing.
OKYO Pharma has announced promising new data from its Phase 2 trial of OK-101 for treating Dry Eye Disease (DED). The trial, involving 240 patients, showed a 68% improvement in the responder rate for those achieving both conjunctival staining and ocular pain endpoints. OK-101 demonstrated a strong tolerability profile, with favorable comfort scores. The analyses identified conjunctival staining and ocular pain as potential co-primary endpoints for future trials. CEO Gary S. Jacob emphasized these endpoints as important for ongoing development, targeting the underserved DED patient population with pain symptoms.
OKYO Pharma (NASDAQ: OKYO) is set to participate in two upcoming investor conferences in May 2024 to present its innovative ocular therapies for inflammatory dry eye disease and anterior ocular segment diseases. The company will be presenting at the Aegis Capital Virtual Healthcare Conference on May 8, 2024, and at the Citizens JMP Securities Life Sciences Conference on May 13, 2024. Gary Jacob, PhD, the Chief Executive Officer, will be the presenter at both conferences.
OKYO Pharma announced the presentation of OK-101 Phase 2 data for dry eye disease at the Dry Horizons Symposium. The company is developing innovative ocular therapies for DED and NCP, aiming to address unmet medical needs.
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