Proactive Investors - OKYO Pharma (NASDAQ:OKYO) unveiled new results showing its lead drug OK-101 has shown significant and measurable improvements in various indicators and symptoms associated with Dry Eye Disease (DED) during its initial Phase 2 trial involving human participants.
These improvements include notably reducing ocular pain, which suggests potential efficacy in treating DED.
In a randomized, double-masked, placebo-controlled trial encompassing 240 patients, OK-101 was effective in alleviating various symptoms associated with DED. The study found that OK-101 helped with ocular pain, conjunctival staining, Tear Film Break-Up Time (TFBUT), burning and stinging sensations, and blurred vision.
According to the trial data, OK-101 demonstrated statistically significant improvements in ocular pain relief as early as day 15, with sustained benefits throughout the trial period. Conjunctival staining exhibited notable enhancement from day 29, maintaining its efficacy throughout the trial, while Tear Film Break-Up Time showcased significant improvement from day 15, persisting throughout the study.
Furthermore, symptoms such as burning/stinging sensation and blurred vision showed marked enhancement from day 15, with sustained improvement throughout the trial duration.
Importantly, OK-101's exceptional tolerability profile, characterized by its drop comfort and ocular tolerability comparable to artificial tears, was highlighted. The trial also recorded a favorable adverse event profile, with no drug-related serious adverse events reported.
“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, medical director of Pepose Vision Institute and professor of clinical ophthalmology at Washington University School of Medicine in St. Louis.
Gary Jacob, CEO of OKYO Pharma, told investors that the company’s enthusiasm for the “highly differentiated benefits” of OK-101 in treating dry eye patients “continues to build.”
“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,” Jacob said.
“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.”
Jacob highlighted OK-101’s apparent ability to act quickly in rapidly reducing 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,” the CEO added.
The company will host a Key Opinion Leader event on April 9, featuring Jay Pepose and Anat Galor, who will delve into the significant findings of the study.
Those interested can register for the event here.