OK-101 Phase 2 Trial Achieves Statistical Significance in Dry Eye Disease Patients

Clinical-stage biopharmaceutical company OKYO Pharma has reported promising results from its Phase 2 trial of OK-101, an ophthalmic solution developed to treat inflammatory dry eye disease (DED). The randomized, double-masked, placebo-controlled study involved 240 participants with DED, who were divided into three groups receiving either 0.05% OK-101, 0.1% OK-101, or a placebo, over a 14-week period.

The trial aimed to evaluate the safety and efficacy of OK-101, and it demonstrated significant improvements in both objective signs and subjective symptoms of DED. Notably, OK-101 outperformed placebo in reducing total conjunctival staining and in alleviating symptoms such as burning/stinging and blurred vision. These improvements were observed as early as the first 15 days post-treatment and continued to show significance up to day 29.

The study also highlighted the drug's favorable safety profile, with a low incidence of adverse events comparable to placebo and no serious drug-related adverse events reported. Furthermore, fewer participants in the OK-101 group discontinued the study medication due to treatment-related adverse events compared to the placebo group.

Dr. Jay Pepose, an expert in the field, underscored the significance of these findings, emphasizing the drug's potential to address a range of dry eye symptoms and its excellent tolerability. The results have paved the way for the advancement of OK-101 into Phase 3 clinical trials, with the goal of developing a product that could significantly benefit patients currently underserved by existing treatments for DED.

OKYO Pharma's CEO, Dr. Gary Jacob, expressed optimism about the future of OK-101, noting the drug's novel mechanism of action and its potential to treat not only DED but also corneal neuropathic pain, a condition lacking FDA-approved therapies. The company plans to leverage the insights gained from this trial to design Phase 3 trials that will further explore OK-101's efficacy and safety.

Dr. Raj Patil, CSO of OKYO Pharma, highlighted the drug's unique properties, including its ability to improve conjunctival staining, a key endpoint for DED drug approval, which has not been demonstrated by other FDA-approved DED drugs. The drug's multifaceted mechanism of action, which includes anti-inflammatory effects and the restoration of mucin-secreting goblet cells in the conjunctiva, is believed to contribute to its efficacy.

The successful completion of the Phase 2 trial marks a significant milestone for OKYO Pharma, which is committed to advancing OK-101 and exploring its potential in treating DED and corneal neuropathic pain. The company's management is planning to provide a comprehensive analysis of the trial results in a conference call scheduled for the first quarter of 2024.

Dry eye disease is a prevalent condition affecting nearly 49 million people in the U.S., characterized by inadequate tear production or tear film dysfunction, leading to ocular surface inflammation and damage. OK-101, a lipid conjugated chemerin peptide agonist, has been designed to target the inflammatory response in the eye and enhance tear film stability, offering a new approach to managing this challenging condition.

OKYO Pharma, listed on the NASDAQ Capital Market, is dedicated to the discovery and development of innovative therapies for DED and ocular pain. The company's recent achievements in the Phase 2 trial of OK-101 for DED treatment underscore its commitment to improving patient outcomes and addressing unmet medical needs in the field of ophthalmology.