OKYO Pharma Ltd (NASDAQ:OKYO) has shared encouraging results from a phase II trial of its treatment candidate for dry eye disease.
The study involved 240 patients and showed that 68% of them had improved by meeting both key measures: reduced conjunctival staining and ocular pain.
The recently released data comes from a randomized, double-masked, placebo-controlled trial. This means that neither the patients nor the researchers knew who was receiving the actual treatment or a placebo, which helps ensure unbiased results. The trial aimed to test the safety and effectiveness of OK-101 eye drops.
Researchers analyzed the data from all participants. They looked at how many patients showed at least a 12.5% reduction in eye redness and at least a 30% reduction in symptoms such as eye pain, blurred vision, or burning and stinging. These improvements were measured from the beginning of the trial to the final visit on day 85.
The results showed that 34.2% of patients treated with OK-101 had less eye redness and pain, compared to 20.3% of those who received the placebo, a 68% improvement.
Similarly, 32.9% of patients treated with OK-101 experienced less redness and burning or stinging, compared to 20.3% of the placebo group, a 62% improvement. There was a smaller difference of 19% in patients reporting less redness and blurred vision.
These findings suggest that the two main signs to look for in future studies of the drug OK-101 are conjunctival staining and ocular pain. OKYO said it plans to focus on these measures in its next evaluation.
“The data from this first-in-human trial of OK-101 in patients with DED have established a clear road map for future clinical development in this indication,” said Gary Jacob, CEO of OKYO Pharma.
“Through our analytical work we have concluded that conjunctival staining and ocular pain represent important and de-risked endpoints to be studied further to help underserved patients whose dry eye symptoms include pain component.
"Furthermore, this trial demonstrated a favorable tolerability profile for OK-101, with an excellent eyedrop comfort score for a topically administered drug.”