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OKYO 资讯
OKYO 事件
Okyo Pharma FDA Meeting Feedback Supports Global Phase 3 Trial for urcosimod
Okyo Pharma announced feedback from its FDA Type D meeting, validating the company's regulatory and clinical path forward for urcosimod and supporting advancement into a global Phase 3 pivotal trial for NCP. The FDA feedback provides increased clarity around the company's updated regulatory strategy, reducing uncertainty and further supporting Okyo's plan to advance urcosimod through a potentially streamlined clinical development pathway. Based on discussions with the Agency, Okyo is positioning the planned NEPTUNE trial as a pivotal study that could support a potential single-trial registration strategy, subject to successful study results and continued FDA review.
OKYO Pharma Announces Positive Findings from Urcosimod Trial
OKYO Pharma announced new positive findings from an exploratory analysis of patient-reported outcomes in its recently completed Phase 2a trial of urcosimod for the treatment of NCP. This new quality-of-life, or QoL, data will be presented at the Association for Research in Vision and Ophthalmology, or ARVO, 2026 Annual Meeting. The presentation, titled: "First-in-Human Study of Urcosimod to Treat Neuropathic Corneal Pain, or NCP, Shows Clinically Meaningful Pain Reduction and Quality-of-Life Improvement in NCP Patients" will detail the Phase 2a clinical trial results, including reductions in pain as measured by the VAS, improvements in patient-reported QoL measures, as well as signals suggesting potential restoration of corneal nerve structure in NCP patients. This event represents a key opportunity to share these new findings with global eye and vision researchers, clinicians, and industry leaders. In this Phase 2, randomized, double-masked, placebo-controlled study, patients with NCP received either 0.05% urcosimod or placebo in the Intent-to-Treat, or ITT, population. After 12 weeks of treatment, patients receiving urcosimod demonstrated greater improvements across key aspects of emotional well-being and quality of life compared to placebo. These measures were assessed on a 0-10 scale. Notable improvements included: Enjoying life/relationships with other people: mean change from baseline of -4.5 for urcosimod vs. 0 for placebo.
Piper Sandler Sets Deal Range at $1.80-$1.90
The deal range was $1.80-$1.90. Piper Sandler acted as sole book running manager for the offering.
Okyo Pharma Plans Underwritten Public Offering of Ordinary Shares
Okyo Pharma Limited announced that it intends to offer to sell its ordinary shares in an underwritten public offering. All of the ordinary shares are to be sold by the company. The company intends to use the net proceeds from the offering primarily for clinical development of its product candidates, general corporate purposes and working capital. Piper Sandler & Co. is acting as the sole book-running manager for the offering.
OKYO Pharma Appoints Flavio Mantelli as Chief Medical Officer
OKYO Pharma announced the appointment of Flavio Mantelli, MD, PhD as Chief Medical Officer. Dr. Mantelli led the clinical development, regulatory approval, and global medical strategy of Oxervate at Dompe farmaceutici S.p.A.
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