OK-101 improves ocular pain, tear breakup time as early as day 15 in phase 2 DED trial
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Key takeaways:
- OK-101 improved ocular pain and tear breakup time as early as day 15.
- OK-101 demonstrated exceptional tolerability and comfort, with no serious drug-related adverse events.
Okyo Pharma has announced additional findings from its phase 2 trial of OK-101, including statistically significant improvement in ocular pain relief, conjunctival staining and tear breakup time in patients with dry eye disease.
“Our enthusiasm for the highly differentiated benefits of OK-101 in treating dry eye patients continues to build,” CEO Gary S. Jacob, PhD, said in a company press release. “OK-101 is the first investigational DED therapeutic, to our knowledge, to demonstrate statistically significant and durable improvements in both tear film breakup time and ocular pain.”
In a double-masked, placebo-controlled study of 240 randomized patients with dry eye disease, researchers reported that OK-101 (0.05%) ophthalmic solution — a lipid-conjugated chemerin peptide agonist — significantly reduced ocular pain and improved TBUT as early as day 15. These benefits continued throughout the trial, the release stated. In addition, conjunctival staining improved as early as day 29, a finding that also demonstrated durability.
The treatment also improved multiple symptoms, including pain, burning, stinging, eye dryness and itching, within the first 2 weeks of treatment, as reported in patient daily diaries.
Further, OK-101 demonstrated exceptional tolerability and comfort, with no drug-related serious adverse events, the release stated.
“The positive impact of OK-101, in its capacity to rapidly and durably improve tear film breakup time, is particularly relevant for so many dry eye patients who have reduced blink rate associated with extensive screen time, reading and driving,” Jay Pepose, MD, PhD, founder and medical director of Pepose Vision Institute and professor of clinical ophthalmology at Washington University School of Medicine in St. Louis, said in the release.
“This improvement in tear film stability correlates well with the improvement of multiple dry-eye associated symptoms, such as blurred vision. A rapid tear film breakup time is observed in all forms of dry eye disease, including aqueous deficiency, evaporative and mixed.”
According to the release, these new findings complement previously reported achievements in sign and symptom endpoints and enable phase 3 development of OK-101.
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