--News Direct--
OKYO Pharma Ltd CEO Gary Jacobs joined Steve Darling from Proactive to share additional 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). This trial involved 240 patients in a randomized, double-masked, placebo-controlled study. OK-101, developed using a membrane-anchored-peptide technology, is a novel long-acting drug candidate designed to treat dry eye disease. It has shown anti-inflammatory and pain-reducing efficacy in mouse models of dry eye disease and corneal neuropathic pain.
Jacobs highlighted that the findings include a statistically significant and durable reduction in ocular pain and a statistically significant improvement in Tear Film Break-Up Time throughout the study, which is a clinically important endpoint. Additionally, multiple symptomatic improvements were observed through both data obtained from patient clinic visits and daily symptom diaries.
Jacob explained that OK-101 targets a receptor called Chemerin 23, present on both immune and nerve cells, including those in the spinal cord and ocular nerves. Preclinical animal studies indicated that OK-101 could reduce neuropathic pain, which can be particularly severe and debilitating in affected patients. The company is preparing to launch a Phase II trial for OK-101 specifically targeting neuropathic corneal pain.
This 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 recognised 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.
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View source version on newsdirect.com: https://newsdirect.com/news/promising-developments-from-okyo-pharma-on-dry-eye-disease-and-neuropathic-pain-treatment-588182175
