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Highlights
- The trial aims to address unmet needs in the billion-dollar inflammatory dry eye disease market.
- OK-101 is the first targeted treatment for NCP, a condition currently managed only with off-label medications.
- The study will evaluate pain relief through a randomized, double-masked approach over 12 weeks.
OKYO Pharma Ltd has officially commenced recruitment for its Phase 2 clinical trial of OK-101, an ocular therapy designed to treat neuropathic corneal pain (NCP).
NCP is a debilitating eye condition characterized by severe pain and sensitivity, and it has long been underserved in terms of approved therapies. With no commercially available treatments, patients often rely on off-label options, which may not adequately address their symptoms. OKYO's efforts to bring OK-101 to market come at a crucial time when the demand for effective therapies in this area is significant.
The Phase 2 trial will involve 48 participants and is structured as a double-masked, randomized study spanning 12 weeks. The primary objective of the trial is to measure pain relief using the Visual Analog Scale (VAS), a well-established method for assessing subjective pain experiences. This rigorous approach reflects OKYO's commitment to ensuring that the efficacy of OK-101 is thoroughly evaluated in a clinical setting.
Gary Jacob, CEO of OKYO Pharma, expressed enthusiasm about the trial's initiation, stating, "The initiation of this trial of topically applied OK-101 to treat NCP marks a significant step forward for the company. We have been laser-focused on moving this drug candidate into a clinical trial to treat NCP over the last 12 months." Jacob emphasized the company's eagerness to explore the potential benefits of OK-101 for patients suffering from this painful condition.
The trial is being conducted at Tufts Medical Center, under the leadership of Dr. Pedram Hamrah, a recognized expert in NCP and co-inventor of the OK-101 patent. Dr. Hamrah expressed optimism about the trial's design, which was developed in consultation with the U.S. Food and Drug Administration (FDA). "We have designed an effective protocol to test our hypothesis in this patient population after productive FDA interactions," he said. His involvement underscores the scientific rigor behind the trial, which is essential for establishing the therapy's safety and efficacy.
OK-101 is a lipid-conjugated chemerin peptide agonist, specifically designed to target inflammatory eye conditions. Its formulation is engineered to prolong its residence time in the ocular environment, potentially enhancing its effectiveness. Previous studies have shown promise in animal models, demonstrating a reduction in neuropathic corneal pain. Moreover, OK-101 recently completed a Phase 2 trial for dry eye disease, yielding statistically significant improvements in symptoms such as ocular pain and stinging.
The company is hopeful that OK-101 will fill a crucial gap in treatment options for patients experiencing neuropathic corneal pain. As the trial progresses, the results could pave the way for a new standard of care in a field that has long been lacking effective solutions.
In summary, OKYO Pharma's initiation of the Phase 2 trial for OK-101 represents a significant milestone in the quest to address the unmet medical need for neuropathic corneal pain. With the potential to revolutionize treatment options for this debilitating condition, OK-101 is positioned as a promising candidate in the ocular therapeutic landscape.
