OKYO Pharma CEO Gary Jacob joined Steve Darling from Proactive to share a significant advancement in the company’s ongoing drug development efforts. The company has successfully demonstrated that urcosimod—formerly known as OK-101—remains stable for more than two and a half years in single-use ampoules, which are used for patient administration. This milestone is a crucial step forward in ensuring the long-term viability of the drug as it progresses through clinical trials. Urcosimod is currently being evaluated in a Phase 2b clinical trial, which is a randomized, placebo-controlled, double-masked study involving 48 patients. The trial is focused on assessing the drug’s effectiveness in treating neurotrophic keratopathy (NCP), a serious and progressive degenerative eye disease. Jacob emphasized that achieving success in clinical development extends beyond obtaining positive clinical trial data. A crucial aspect of regulatory approval includes meeting the rigorous Chemistry, Manufacturing, and Controls (CMC) requirements set by the U.S. Food and Drug Administration (FDA). By demonstrating long-term stability, OKYO Pharma has strengthened its regulatory submission package, addressing an essential factor in the drug’s future approval and commercialization. The company recently completed Good Manufacturing Practice (GMP) stability assay testing of single-use ampoules containing urcosimod in an ophthalmic solution. The results were highly promising—ampoules stored under refrigerated conditions maintained stability for over two and a half years, while initial three-month data from samples stored at room temperature showed potency levels at or above 100%. These findings reinforce confidence in urcosimod’s shelf life and its potential for real-world clinical use. As OKYO Pharma continues to advance urcosimod through the regulatory and clinical development process, this stability milestone represents a critical achievement in its journey toward providing an effective treatment for patients suffering from NCP. #proactiveinvestors #okyopharmalimited #nasdaq #okyo