OK-101 Phase 2 Trial Achieves Statistical Significance in Dry Eye Disease Symptoms and Ocular Pain Relief

OKYO Pharma Limited, a biopharmaceutical firm, has announced promising results from its Phase 2 clinical trial of OK-101, a novel ophthalmic solution for inflammatory dry eye disease (DED). The trial involved 240 patients and demonstrated significant improvements in various symptoms associated with DED, including ocular pain, conjunctival staining, and tear film stability.

The study showed that OK-101 led to a substantial and enduring reduction in ocular pain, with benefits observed as early as day 15 of the trial. Similarly, improvements in conjunctival staining were noted from day 29, and these benefits were sustained throughout the trial period. Tear Film Break-Up Time (TFBUT), a key indicator of eye health, also saw significant enhancements from day 15, with the positive effects lasting for the duration of the study.

In addition to these clinical improvements, patients reported relief from burning/stinging sensations and blurred vision, with noticeable benefits from day 15 onwards. The trial also utilized daily symptom diaries, which corroborated the clinical findings, indicating significant improvements in pain, burning/stinging, eye dryness, and itching within the initial two weeks of treatment.

OK-101 was found to be exceptionally comfortable to use, with a tolerability profile akin to that of artificial tears. The drug exhibited a favorable safety profile, with no serious adverse events related to the medication and a low incidence of treatment-emergent adverse events, similar to the placebo group.

The positive outcomes of the trial are particularly significant given the proposed mechanism of action of OK-101, which involves normalizing goblet cell density and improving the conjunctiva's health, thereby reducing ocular pain and inflammatory activity. The increase in goblet cell density is expected to boost mucin production, a crucial component of the tear film's physiology.

Patient-reported outcomes from daily symptom diaries further validated the clinical results, showing significant symptom improvements from day one. The rapid and durable symptom relief, combined with OK-101's exceptional comfort and safety, positions the drug as a potential market leader in the treatment of DED.

Dr. Jay Pepose, a leading ophthalmologist, highlighted the relevance of OK-101's impact on tear film stability, especially for patients with reduced blink rates due to prolonged screen time, reading, or driving. Dr. Gary S. Jacob, CEO of OKYO, expressed enthusiasm for the drug's differentiated benefits in treating DED, citing the comprehensive data supporting the proposed mechanism of action and the drug's rapid symptom reduction.

OK-101 is a lipid-conjugated chemerin peptide agonist that targets immune cells in the eye responsible for inflammation. It was developed using a membrane-anchored-peptide technology to enhance its residence time within the ocular environment. The drug has shown anti-inflammatory and pain-reducing effects in mouse models of DED and corneal neuropathic pain.

OKYO Pharma, listed on the NASDAQ Capital Market, is focused on discovering and developing novel treatments for DED and ocular pain. The company is also planning a Phase 2 trial for OK-101 to treat neuropathic corneal pain.

The Phase 2 trial was a double-masked, randomized, placebo-controlled study conducted at six U.S. sites, with patients receiving twice-daily doses of OK-101 or placebo for 14 weeks. The trial's design aimed to exclude placebo responders and ensure the robustness of the results.

Ora, Inc., a leading ophthalmic drug and device development firm, conducted the trial. With over 45 years of experience and a global presence, Ora has helped secure more than 85 product approvals, utilizing its extensive team of experts and unique methodologies.

OK-101's development and the Phase 2 trial's results represent a significant step forward in the treatment of DED, offering a new therapeutic option with demonstrated efficacy and safety.