The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to OKYO Pharma for its investigational candidate urcosimod, intended for the treatment of neuropathic corneal pain (NCP). NCP is a rare and severely painful condition affecting the eyes, face, or head, believed to result from nerve damage in the cornea combined with inflammation.

美国食品和药物管理局（FDA）已授予OKYO制药公司快速通道资格，用于其在研候选药物urcosimod，旨在治疗神经性角膜疼痛（NCP）。NCP是一种罕见且极度痛苦的疾病，影响眼睛、面部或头部，被认为是由角膜神经损伤与炎症共同引起的。

Currently, there are no FDA-approved treatments for this condition..

目前，对于这种疾病尚无FDA批准的治疗方法。

Regulatory Pathway Enhanced for Accelerated Development

加速开发的监管途径得到增强

OKYO Pharma had submitted its Fast Track application in March 2025. With the designation now granted, the company gains access to:

奥基奥制药公司在2025年3月提交了其快速通道申请。随着这一资格的授予，该公司获得了以下权限：

• More frequent interactions with the FDA to align trial design and data collection

• 更频繁地与FDA互动，以协调试验设计和数据收集

• Eligibility for rolling review, allowing sections of the new drug application (NDA) to be submitted and reviewed on an ongoing basis

• 符合滚动审查的资格，允许新药申请（NDA）的部分内容被持续提交和审查

This designation is intended to accelerate the development timeline and facilitate earlier access to patients in need.

该指定旨在加快开发时间表，并促进有需要的患者更早获得治疗。

CEO Statement on FDA Milestone

首席执行官关于FDA里程碑的声明

Gary S. Jacob, PhD, CEO of OKYO Pharma, commented on the FDA’s decision in a recent company press release:

OKYO制药公司的首席执行官Gary S. Jacob博士在公司最近的新闻稿中对FDA的决定发表了评论：

“We are thrilled with the FDA’s Fast Track designation for urcosimod in the treatment of neuropathic corneal pain. This milestone underscores our commitment to advancing innovative therapies that can make a meaningful difference in patients’ lives. We look forward to working closely with the FDA to bring this promising treatment to patients as quickly as possible.”.

“我们对乌索西莫德治疗神经性角膜疼痛获得FDA的快速通道资格感到非常兴奋。这一里程碑凸显了我们致力于推进能够对患者生活产生有意义影响的创新疗法。我们期待与FDA密切合作，尽快将这种有前景的治疗方法带给患者。”

Urcosimod: Novel Mechanism Targeting ChemR23 Pathways

乌尔科西莫德：针对ChemR23通路的新机制

Urcosimod is described by OKYO Pharma as a lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein-coupled receptor (GPCR). This receptor is expressed on:

OKYO Pharma 将 Urcosimod 描述为 ChemR23 G 蛋白偶联受体 (GPCR) 的脂质结合型趋化素肽激动剂。该受体表达于：

• Immune cells in the eye responsible for mediating inflammatory responses

• 眼睛中负责介导炎症反应的免疫细胞

• Neurons and glial cells in the dorsal root ganglion associated with sensory processing

• 与感觉处理相关的背根神经节中的神经元和胶质细胞

The dual presence of ChemR23 in both inflammatory and sensory pathways highlights urcosimod’s potential to address both pain and inflammation in NCP.

ChemR23 在炎症和感觉通路中的双重存在突显了尿苷莫德在 NCP 中解决疼痛和炎症的潜力。

Long-Term Stability and Clinical Trial Progress

长期稳定性与临床试验进展

OKYO Pharma recently announced positive long-term stability data for urcosimod, confirming the drug’s stability for over 2.5 years in single-use ampoules used for patient administration.

OKYO制药公司最近宣布了乌索莫德的长期稳定性数据，证实该药物在用于患者给药的单剂量安瓿中稳定性超过2.5年。

Urcosimod is currently being evaluated in a Phase 2b clinical trial:

乌索莫德目前正在一项 2b 期临床试验中进行评估：

• Randomized, placebo-controlled, and double-masked

• 随机、安慰剂对照和双盲

• Enrolling 48 patients with NCP

• 注册48名NCP患者

• First patient was dosed in October 2024

• 首位患者于2024年10月给药

This study aims to further assess the safety and efficacy of urcosimod in treating this high-unmet-need condition.

本研究旨在进一步评估乌索莫德治疗这种高度未满足需求状况的安全性和有效性。