OKYO Pharma Reports Promising Findings for Dry Eye Disease and Neuropathic Pain Treatments
TL;DR
OK-101 shows statistically significant reduction in ocular pain, giving OKYO Pharma a potential edge in dry eye treatment market.
OK-101, a long-acting drug candidate developed using membrane-anchored-peptide technology, targets Chemerin 23 receptor to reduce neuropathic pain.
OK-101's Phase 2 trial results offer hope for relief to patients suffering from excruciating neuropathic corneal pain, addressing a therapeutic gap.
OK-101, a novel long-acting drug candidate, has shown anti-inflammatory and pain-reducing efficacy in mouse models of dry eye disease and corneal neuropathic pain.
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OKYO Pharma Ltd CEO Gary Jacobs recently shared key findings from a Phase 2 clinical trial evaluating the safety and efficacy of OK-101 (0.05%) ophthalmic solution in patients with dry eye disease (DED). The trial, which involved 240 patients, was a randomized, double-masked, placebo-controlled study. Developed using a membrane-anchored-peptide technology, OK-101 is a novel long-acting drug candidate for treating dry eye disease, showing anti-inflammatory and pain-reducing efficacy in mouse models of both dry eye disease and corneal neuropathic pain.
Jacobs highlighted that the trial results include a statistically significant and durable reduction in ocular pain and a significant improvement in Tear Film Break-Up Time, a clinically important endpoint. Multiple symptomatic improvements were observed from patient clinic visits and daily symptom diaries, indicating the drug's effectiveness.
OK-101 targets a receptor called Chemerin 23, found on immune and nerve cells, including those in the spinal cord and ocular nerves. Preclinical animal studies showed that OK-101 could reduce neuropathic pain, a particularly severe and debilitating condition in affected patients. The company is preparing to launch a Phase II trial for OK-101 specifically targeting neuropathic corneal pain.
This upcoming trial will be placebo-controlled and randomized, involving 48 patients diagnosed with ocular nerve damage through confocal microscopy, with top-line data expected by mid-2025. The significance of this development lies in the current lack of FDA-approved treatments for neuropathic corneal pain, a condition recognized by the National Organization of Rare Diseases. The trial aims to fill this therapeutic gap, potentially offering relief to patients suffering from this excruciating condition.
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