LONDON and NEW YORK - OKYO Pharma Limited (NASDAQ: OKYO), a biopharmaceutical company specializing in ocular therapies, has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 2 clinical trial for its drug candidate OK-101, aimed at treating neuropathic corneal pain (NCP). This represents the first Investigational New Drug (IND) clearance for a potential NCP treatment, addressing a significant unmet medical need.
The planned double-masked, placebo-controlled trial is set to commence in the second quarter of 2024, enrolling 54 patients with confirmed NCP. The study's primary goal is to measure the efficacy of OK-101 in providing pain relief, gauged by Visual Analogue Scale (VAS) scores.
Pedram Hamrah, MD, an expert in NCP and co-inventor of the OK-101 patent, will lead the single-center trial at Tufts Medical Center. Dr. Hamrah expressed his satisfaction with the FDA's clearance, which opens the door for clinical testing of drugs in this category.
OK-101 has previously shown promise in a Phase 2 trial for dry eye disease, demonstrating favorable tolerability and significant symptom improvement. Additionally, in a mouse model, the drug significantly reduced ocular neuropathic pain. OK-101's design incorporates a lipid anchor to enhance its residence time within the ocular environment, potentially providing long-lasting effects.
NCP is characterized by eye pain and sensitivity, often resulting from nerve damage and inflammation. While various off-label treatments are currently in use, there are no FDA-approved therapies specifically for NCP.
This news is based on a press release statement from OKYO Pharma Limited.
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