OKYO Pharma (OKYO) announces a clinical update and its interim results for the six months ended 30 September 2024. Neuropathic Corneal Pain, NCP: The Company anticipates completing enrollment of the 48-patient trial by the end of 2Q 2025 and releasing top-line data on the Phase 2a trial in 4Q 2025. Results from this trial are anticipated to be a major binary event for the Company. Dry Eye Disease: In January of 2024, OKYO reported positive top line data from the Phase 2b trial of OK-101 to treat DED patients. This OK-101 first-in-human Phase 2b trial established a clear clinical path for potential further clinical development via a Phase 3 study design using FDA-recognized endpoints. OK-101 demonstrated statistically significant benefit in a “sign” endpoint, namely “total conjunctival staining” as measured by the Ora Calibra Staining Scale as early as Day 29. OK-101 also improved at least two “symptom” endpoints of DED, including “burning/stinging” as measured by the Ora Calibra 4-symptom questionnaire, and as measured by a visual analog scale as early as Day 15, as well as “blurred vision”, with statistically significant improvement in blurred vision occurring by Day 29.
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