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

• Ocular Pain Relief showed statistically significant improvement as early as day 15 and the benefit was durable throughout the trial.
  
• Conjunctival Staining improved as early as day 29 with a durable benefit throughout the trial.
• Tear Film Break-up Time showed statistically significant improvement as early as day 15 with the benefit durable for the remainder of the trial.
• Burning/Stinging, and Blurred Vision improved as early as day 15 and the benefit remained durable throughout the trial.
• Significant improvements were observed across multiple symptoms as measured in a daily symptom diary including pain, burning/stinging, eye dryness and itching within the first two weeks of treatment.
  
• OK-101 exhibited exceptional drop comfort, comparable to that of artificial tear, with very good ocular tolerability along with a favorable adverse event profile and no drug-related serious adverse events.
• These observed endpoints support the proposed mechanism-of-action of OK-101 as demonstrated in preclinical animal models.
  

LONDON and NEW YORK, March 22, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and anterior ocular segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, announced today additional key findings from analyses of the clinical data set from the 240 patient Phase 2, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of OK-101 (0.05%) ophthalmic solution in patients with DED.

These new findings include:

• a statistically significant and durable reduction in ocular pain
• statistically significant improvement in Tear Film Break-Up Time (TFBUT) throughout the study - a clinically important endpoint
• multiple symptomatic improvements as observed by both data obtained from patient clinic visits as well as data from patient daily symptom diaries
  

These results complement the statistically significant effects reported earlier on sign and symptoms endpoints, enabling definitive Phase 3 development of OK-101; using FDA recognized endpoints per the Dry Eye: Developing Drugs for Treatment Guidance for Industry.  
https://www.fda.gov/media/144594/download.