Biopharmaceutical company OKYO Pharma Limited has reported positive safety and efficacy results in its Phase 2 trial evaluating the safety and efficacy of OK-101 ophthalmic solution for dry eye disease (DED).
The company said statistically significant improvement was observed in both a ‘sign’ (total conjunctival staining) and two ‘symptoms’ (burning/stinging and blurred vision) of DED.
As well, the company said OK-101 exhibited “placebo-like tolerability with a very low adverse event profile and no drug-related serious adverse events”.
Ameliorating this unique constellation of signs and symptoms may reflect the differentiated mechanism of action of OK-101
“It is remarkable that in this first in human study of OK-101 ophthalmic solution, an analysis of all randomised subjects demonstrated a persistent, statistically significant improvement in multiple dry eye-related symptoms as early as day 15, along with a sign, total conjunctival lissamine green staining, by day 29,” said Professor Jay Pepose of Washington University School of Medicine in St Louis.
“Ameliorating this unique constellation of signs and symptoms may reflect the differentiated mechanism of action of OK-101.
“Also of note, drop comfort was excellent and the safety profile favourable,” Professor Pepose said. The comments were made in a media release issued by OKYO Pharma.
OKYO Pharma said a “clear and informed path” was now established for “further development of (the) drug through Phase 3 registration trials”.
