OK-101 achieves dry eye disease sign, symptom endpoints in phase 2 trial
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Okyo Pharma announced positive safety and efficacy data from its phase 2 trial of OK-101 ophthalmic solution, a lipid-conjugated chemerin peptide agonist designed to reduce pain and inflammation in patients with dry eye disease.
“It is remarkable that in this first-in-human study of OK-101 ophthalmic solution, an analysis of all randomized 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,” Jay Pepose, MD, PhD, founder and medical director at Pepose Vision Institute and professor of clinical ophthalmology at Washington University School of Medicine in St. Louis, said in an Okyo Pharma press release.
The study enrolled 240 participants with dry eye disease, who were randomized into three cohorts and dosed twice daily with 0.05% OK-101, 0.1% OK-101 or vehicle for 12 weeks after a 2-week run-in period on placebo.
According to the release, OK-101 outperformed placebo in total conjunctival staining by day 29 and burning or stinging symptoms as early as day 15. Results also showed a statistically significant improvement in blurred vision at day 29.
Treatment-emergent adverse events were comparable between placebo and treatment groups, the release stated, with no severe drug-related ocular events observed. In addition, more placebo-treated patients discontinued use compared with treated patients.
“These results are extremely encouraging and will steer the selection of the future primary endpoints of subsequent phase 3 trials of OK-101 to treat DED,” Okyo CEO Gary S. Jacob said in the release.
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