21-07-2025
OKYO reports top-line data from neuropathic corneal pain therapy trial
OKYO Pharma has reported encouraging top-line outcomes from the randomised Phase II trial of urcosimod (previously referred to as OK-101), aimed at treating neuropathic corneal pain (NCP).
The double-masked, placebo-controlled trial was carried out at Tufts Medical Center in Boston, US, with Pedram Hamrah as the principal investigator.
Its primary endpoint was the change in mean pain scores from baseline to the end of the 12-week treatment period, measured using Visual Analogue Scale (VAS) scores of zero to ten.
The company noted that, for the per-protocol population, the 0.05% urcosimod group showed a mean pain score change of 5.5 while the placebo group had a change of 2.75, indicating a 2.75 delta difference between the drug and the placebo after 12 weeks of treatment.
In addition, 75% of subjects treated with 0.05% urcosimod achieved an improvement in pain severity of over 80%.
The 0.05% therapy showed a marked decrease in pain scores as early as week four, with a mean change of 5.25, compared with 3.0 for the placebo.
Although the placebo group also saw improvement, it was notably less than that of the urcosimod group, and 75% of those subjects had only mild NCP pain scores at baseline.
In the intent-to-treat subjects, 67% of those in the 0.05% group showed an improvement of more than 50% in pain, versus 33% in the placebo group.
The mean decrease in pain severity was 4.2 for the 0.05% therapy group, versus 2.5 for the placebo group. A Cohen-d value of greater than 1.2 indicated a strong treatment impact.
Cohen-d is a statistical metric used to evaluate and contrast the effect size of the trial medication with that of the placebo.
NCP causes intense pain and sensitivity in the eyes, as well as the face and head.
The company noted that the Phase II trial of urcosimod was planned to enrol 48 subjects, but OKYO Pharma closed the trial early in April this year. With 17 subjects having completed the trial, the decision was based on the company's aim to unmask the data for an early readout on the drug's impact.
OKYO Pharma CEO Gary Jacob said: 'We are thrilled with these initial top-line results in patients treated with urcosimod from this first in-human Phase II trial.
'In particular, the results strengthen our conviction that this drug may be particularly effective at showing a significant reduction in pain in patients with a greater degree of neuropathic pain.'
In 2023, OKYO screened the first subject in its Phase II trial of OK-101 ophthalmic solution to treat dry eye disease (DED).
"OKYO reports top-line data from neuropathic corneal pain therapy trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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