Shares of OKYO Pharma (NASDAQ:OKYO) rose more than 7% in premarket trade on Friday, on additional key findings from analyses of the clinical data set from the 240 patient Phase 2 trial evaluating the safety and efficacy of OK-101 ophthalmic solution in patients with dry eye disease.
“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,” the company said.
Furthermore, OKYO Pharma said, the Ocular Pain Relief showed statistically significant improvement as early as day 15 and the benefit was durable throughout the trial.
“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,” it added.
These observed endpoints support the proposed mechanism-of-action of OK-101 as demonstrated in preclinical animal models.
According to OKYO Pharma (OKYO), 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.
“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, M.D., Ph.D., Founder and Medical Director of Pepose Vision Institute.
OKYO shares rose +7.38% premarket to $1.89.
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