LONDON and NEW YORK - OKYO Pharma Limited (NASDAQ: OKYO), a biopharmaceutical company developing treatments for inflammatory dry eye disease (DED) and other anterior ocular segment diseases, has announced key findings from their Phase 2 trial of OK-101. The trial demonstrated statistically significant and durable improvements in ocular pain relief and tear film stability, essential for DED management.
The double-masked, placebo-controlled study involved 240 patients and focused on the efficacy and safety of OK-101 (0.05%) ophthalmic solution. Significant enhancements in ocular pain, Tear Film Break-Up Time (TFBUT), and other symptoms like burning/stinging and blurred vision were reported as early as day 15 and sustained throughout the trial.
Patient-reported outcomes also indicated notable symptom relief, reinforcing the clinical observations. Moreover, OK-101 was very well tolerated, with a favorable adverse event profile and no serious drug-related adverse events, comparing favorably to artificial tears in terms of drop comfort.
These findings support the proposed mechanism of action seen in preclinical models, suggesting that OK-101 may contribute to a healthier conjunctiva and reduced inflammation. The drug's rapid onset of action and sustained benefits underscore its potential as a novel treatment for DED, a condition exacerbated by modern habits like prolonged screen time.
Dr. Gary S. Jacob, CEO of OKYO, expressed optimism about OK-101's differentiated benefits in treating DED, particularly its rapid and durable improvements in both tear-film breakup time and ocular pain. The company plans to proceed with definitive Phase 3 development, guided by FDA-recognized endpoints.
A Key Opinion Leader event is scheduled for April 9th, 2024, to discuss these findings in depth. The information in this article is based on a press release statement from OKYO Pharma Limited.
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