OKYO Pharma Ltd CEO Gary Jacobs recently shared key findings from the 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 included 240 patients in a randomized, double-masked, placebo-controlled study. OK-101, developed using membrane-anchored-peptide technology, is a novel long-acting drug candidate designed to treat dry eye disease. It has demonstrated anti-inflammatory and pain-reducing efficacy in mouse models of dry eye disease and corneal neuropathic pain.
Jacobs disclosed that the study findings showed a statistically significant and durable reduction in ocular pain and a notable improvement in Tear Film Break-Up Time, a crucial clinical endpoint. Additionally, multiple symptomatic improvements were observed through both data obtained from patient clinic visits and daily symptom diaries.
OK-101 targets a receptor called Chemerin 23, present on immune and nerve cells, including those in the spinal cord and ocular nerves. Preclinical animal studies have indicated that OK-101 could reduce neuropathic pain, a particularly severe and debilitating condition for many patients. The company is preparing to launch a Phase II trial for OK-101 specifically targeting neuropathic corneal pain.
This upcoming trial will be a placebo-controlled, randomized study involving 48 patients diagnosed with ocular nerve damage through confocal microscopy, with top-line data anticipated by mid-2025. The significance of this development is underscored by the lack of FDA-approved treatments for neuropathic corneal pain, a condition recognized by the National Organization of Rare Diseases. The upcoming trial aims to fill this therapeutic gap, potentially offering relief to patients suffering from this excruciating condition.
