OK-101 improves conjunctival staining, ocular pain in phase 2 trial of dry eye disease
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Key takeaways:
- The treatment group had a 68% improvement in conjunctival staining and ocular pain.
- The number of patients with reduced conjunctival staining and burning/stinging symptoms also was higher in the treatment group.
Okyo Pharma released new data from its phase 2 trial of OK-101, a lipid conjugated chemerin peptide agonist, which showed a 68% improvement in both conjunctival staining and ocular pain among patients with dry eye disease.
“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,” Gary S. Jacob, PhD, CEO of Okyo Pharma, said in a company press release.
The randomized, double-masked, placebo-controlled trial assessed the safety and efficacy of OK-101 ophthalmic solution through 85 days among 240 patients with dry eye disease.
According to the release, 34.2% of participants in the OK-101 treatment group demonstrated a reduction in conjunctival sum staining and pain compared with 20.3% in the placebo group, a 68% improvement. The number of patients with reduced conjunctival sum staining and burning or stinging symptoms also was higher in the treatment group (32.9%) vs. the placebo group (20.3%), a 62% improvement.
However, the difference in response between groups was smaller (19%) when evaluating the combination of conjunctival staining and blurred vision.
“Through our analytical work we have concluded that conjunctival staining and ocular pain represent important and derisked endpoints to be studied further to help underserved patients whose dry eye symptoms include a pain component,” Jacob said in the release. “Furthermore, this trial demonstrated a favorable tolerability profile for OK-101, with an excellent eye drop comfort score for a topically administered drug.”
The company noted that conjunctival staining and ocular pain could be coprimary endpoints for future studies, as the FDA “requires a sign and symptom endpoint in two well-controlled registration trials for approval.”
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