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 in a double-masked, randomised, placebo-controlled Phase 2 trial conducted at six sites in the United States.
The company said OK-101 exhibited “placebo-like tolerability with a very low adverse event profile and no drug-related serious adverse events”. Additionally, fewer subjects in the OK-101 treated arm discontinued study medication (2.5%) compared to discontinuations in the placebo treated patients (3.8%).
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.1
OKYO Pharma said a “clear and informed path” was now established for “further development of (the) drug through Phase 3 registration trials”.
Reference
OKYO Pharma announces OK-101 successfully achieved statistical significance for both sign and symptom endpoints in its first-in-human Phase 2 trial of OK-101 in patients with dry eye disease. 8 January 2024. okyopharma.com/okyo-pharma-announces-ok-101-successfully-achieved-statistical-significance-for-both-sign-and-symptom-endpoints-in-its-first-in-human-phase-2-trial-of-ok-101-in-patients-with-dry-eye-disease.
