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OKYO Pharma announces additional statistically significant findings in results from Phase 2 trial of OK-101 (0.05%)


Multiple symptomatic improvements, as well as tear film break-up time improvements and a reduction in ocular pain, were noted.

Researchers looking at computer Image Credit: AdobeStock/Gorodenkoff

Image Credit: AdobeStock/Gorodenkoff

OKYO Pharma, a clinical-stage biopharmaceutical company, announced additional key findings from clinical data set analyses from its Phase 2 clinical trial evaluating the safety and efficacy of OK-101 (0.05%), an ophthalmic solution for patients with dry eye disease (DED), according to a news release. The randomized, double-masked, placebo-controlled trial evaluated 240 patients.1

The new analyses found that there was a statistically significant and durable reduction in ocular pain and improvement of tear film break-up time (TFBUT), symptoms of burning and/or stinging and blurred vision in as early as day 15, with conjunctival staining improving as early as day 29. Both were found durable throughout the remaining trial period. Additional symptoms such as eye dryness and itching were also found to have significantly improved within the first 2 weeks of treatment.1

“The positive impact of OK-101, in its capacity to rapidly and durably improve tear film break up time, is particularly relevant for so many dry eye patients who have reduced blink rate associated with extensive screen time, reading and driving,” said Jay Pepose, MD, PhD, founder and medical director of Pepose Vision Institute and Professor of Clinical Ophthalmology at Washington University School of Medicine in St. Louis, in the release. “This improvement in tear film stability correlates well with the improvement of multiple dry-eye associated symptoms, such as blurred vision. A rapid tear film break-up time is observed in all forms of dry eye disease, including aqueous deficiency, evaporative and mixed.”

On TFBUT, the release noted that “it has been difficult to demonstrate statistical significance for the measurement of increase in TFBUT in clinical trials of DED treatments, due mainly to patient-to-patient variability. The positive results observed in this trial carry particular significance as OK-101’s proposed (mechanism of action, or) MOA involves the normalization of goblet cell density as well as generating a healthier conjunctiva, a reduction of ocular pain and decreased inflammatory activity. An increase in goblet cell density should be expected to lead to an increase in mucin production, playing a key role in the physiology of the corneal tear film.”1

Given these findings, OK-101 was found to be extremely well tolerated with a drop comfort score of 2.3 after 2 minutes post-instillation, with placebo-like tolerability also noted with a very low adverse event profile and no drug-related serious adverse events.1

“Our enthusiasm for the highly differentiated benefits of OK-101 in treating dry eye patients continues to build,” said Gary S Jacob, PhD, CEO of OKYO in the release. “OK-101 is the first investigational DED therapeutic, to our knowledge, to demonstrate statistically significant and durable improvements in both tear-film breakup time, and ocular pain. What is exciting to us is the totality of the data that we are seeing, including the improvement in conjunctival integrity, positive increase in tear-film breakup time, and improvements in the symptom endpoints of burning and stinging and blurry vision, all supporting the proposed MOA that we uncovered in preclinical animal models. Finally, OK-101 also appears to act quickly, displaying rapid reduction of ocular DED symptoms. These clinical benefits combined with OK-101’s exceptional tolerability profile make OK-101 a novel and promising therapeutic agent with the potential for a market leading position in DED.”

These most recent findings also complement other statistically significant effects reported on sign and symptoms endpoints, which enabled definitive Phase 3 development of OK-101.1

  1. OKYO Pharma Announces OK-101 Successfully Achieved Statistical Significance for Multiple Signs and Symptoms of Dry Eye Disease including Ocular Pain Relief in its First-in-Human Phase 2 Trial of OK-101. OKYO Pharma. News release. Published March 22, 2024. Accessed March 22, 2024. https://okyopharma.com/okyo-pharma-announces-ok-101-successfully-achieved-statistical-significance-for-multiple-signs-and-symptoms-of-dry-eye-disease-including-ocular-pain-relief-in-its-first-in-human-phase-2-trial-of-ok-10/
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