Overview
OKYO Pharma Limited, a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and neuropathic corneal pain (NCP), an ocular condition associated with pain but without a US FDA approved therapy, has announced promising new categorical data analyses from the recent OK-101 phase 2 trial in DED patients. These analyses have identified conjunctival staining and ocular pain as the highest potential “sign” and “symptom” co-primary endpoints to be explored in the next DED trial of OK-101.
Words from CEO: OKYO Pharma
- 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,” said Gary S. Jacob, CEO of OKYO Pharma.
- Through our analytical work we have concluded that conjunctival staining and ocular pain represent important and de-risked endpoints to be studied further to help underserved patients whose dry eye symptoms include pain component. Furthermore, this trial demonstrated a favorable tolerability profile for OK-101, with an excellent eyedrop comfort score for a topically administered drug.
Endpoints
Encouraging 68 per cent improvement in responder rate results from patients who achieved both the conjunctival staining “sign” and ocular pain “symptom” endpoints from the 240 patients phase 2 dry eye disease trial.
Conjunctival staining and ocular pain represent potential co-primary endpoints to be explored in future trials.
Words from chairman: OKYO Pharma
- Dry eye disease encompasses a diverse and dissatisfied patient population who needs treatment alternatives to available anti-inflammatory medicines which are insufficient to alleviate the broad spectrum of bothersome ocular symptoms encompassed by this condition,” said Gabriele Cerrone, non-executive chairman of OKYO Pharma.
- We continue to advance our innovative program which focuses on the segment of patients most impacted by ocular pain, and will evaluate next steps for dry eye with our advisors and the regulatory agencies.
Categorical analysis details: Recently released data from the phase 2, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of OK-101 ophthalmic solution in subjects with DED were analyzed by categorical evaluation of the data set and responder-rate analyses. Importantly, the data set for the analysis utilized the full Intent-to-Treat population of 240 patients (for additional details, please refer to slides in the recently issued 6-K filing).
