OKYO Pharma Files for Fast Track Designation with FDA for Urcosimod to Treat Neuropathic Corneal Pain
OKYO Pharma (NASDAQ: OKYO) has filed an application for Fast Track designation with the FDA for its drug urcosimod (formerly OK-101) to treat neuropathic corneal pain. This condition, affecting tens of thousands globally, is characterized by chronic, severe eye discomfort with no current FDA-approved treatment.
The company is developing urcosimod for both neuropathic corneal pain and inflammatory dry eye disease, the latter representing a multi-billion-dollar market opportunity. Fast Track designation is designed to expedite the development and review process for drugs treating serious conditions that lack FDA-approved treatments.
OKYO Pharma (NASDAQ: OKYO) ha presentato una domanda per la designazione Fast Track presso la FDA per il suo farmaco urcosimod (precedentemente OK-101) per trattare il dolore corneale neuropatico. Questa condizione, che colpisce decine di migliaia di persone a livello globale, è caratterizzata da un disagio oculare cronico e severo, senza alcun trattamento attualmente approvato dalla FDA.
L'azienda sta sviluppando urcosimod sia per il dolore corneale neuropatico che per la malattia infiammatoria dell'occhio secco, quest'ultima rappresentando un'opportunità di mercato da miliardi di dollari. La designazione Fast Track è progettata per accelerare il processo di sviluppo e revisione dei farmaci che trattano condizioni gravi prive di trattamenti approvati dalla FDA.
OKYO Pharma (NASDAQ: OKYO) ha presentado una solicitud para la designación de Fast Track ante la FDA para su medicamento urcosimod (anteriormente OK-101) para tratar el dolor corneal neuropático. Esta condición, que afecta a decenas de miles de personas en todo el mundo, se caracteriza por una incomodidad ocular crónica y severa, sin ningún tratamiento aprobado por la FDA en la actualidad.
La empresa está desarrollando urcosimod tanto para el dolor corneal neuropático como para la enfermedad inflamatoria del ojo seco, siendo esta última una oportunidad de mercado de miles de millones de dólares. La designación de Fast Track está diseñada para acelerar el proceso de desarrollo y revisión de medicamentos que tratan condiciones graves que carecen de tratamientos aprobados por la FDA.
OKYO Pharma (NASDAQ: OKYO)는 신경병성 각막 통증 치료를 위한 약물 urcosimod(이전 이름: OK-101)의 Fast Track 지정을 FDA에 신청했습니다. 이 상태는 전 세계 수만 명에게 영향을 미치며, 현재 FDA에서 승인된 치료법이 없는 만성적이고 심각한 눈의 불편함이 특징입니다.
회사는 urcosimod를 신경병성 각막 통증과 염증성 안구 건조증 모두에 대해 개발하고 있으며, 후자는 수십억 달러 규모의 시장 기회를 나타냅니다. Fast Track 지정은 FDA에서 승인된 치료가 없는 심각한 질환을 치료하는 약물의 개발 및 검토 과정을 가속화하기 위해 설계되었습니다.
OKYO Pharma (NASDAQ: OKYO) a déposé une demande de désignation Fast Track auprès de la FDA pour son médicament urcosimod (anciennement OK-101) destiné à traiter la douleur cornéenne neuropathique. Cette condition, qui touche des dizaines de milliers de personnes dans le monde, se caractérise par un inconfort oculaire chronique et sévère, sans traitement actuellement approuvé par la FDA.
L'entreprise développe urcosimod à la fois pour la douleur cornéenne neuropathique et pour la maladie inflammatoire de l'œil sec, cette dernière représentant une opportunité de marché de plusieurs milliards de dollars. La désignation Fast Track est conçue pour accélérer le processus de développement et d'examen des médicaments traitant des conditions graves qui manquent de traitements approuvés par la FDA.
OKYO Pharma (NASDAQ: OKYO) hat einen Antrag auf Fast-Track-Status bei der FDA für sein Medikament urcosimod (früher OK-101) zur Behandlung von neuropathischen Hornhautschmerzen eingereicht. Diese Erkrankung, die weltweit Zehntausende betrifft, ist durch chronische, schwere Augenbeschwerden gekennzeichnet, für die es derzeit keine von der FDA genehmigte Behandlung gibt.
Das Unternehmen entwickelt urcosimod sowohl für neuropathische Hornhautschmerzen als auch für die entzündliche Augentrockenheit, wobei letzteres eine Marktchance im Milliardenbereich darstellt. Der Fast-Track-Status soll den Entwicklungs- und Prüfungsprozess für Medikamente beschleunigen, die ernsthafte Erkrankungen behandeln, für die es keine von der FDA genehmigten Behandlungen gibt.
- Potential entry into multi-billion-dollar dry eye disease market
- Fast Track designation could accelerate FDA review process
- Addressing unmet medical need with no current FDA-approved treatments
- Drug still in clinical stage with uncertain approval timeline
- No efficacy data presented in the announcement
LONDON and NEW YORK, March 10, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain, a severe ocular condition without an FDA approved therapy, and for inflammatory dry eye disease, a multi-billion-dollar market, is pleased to announce the filing of its application for Fast Track designation with the U.S. Food and Drug Administration (FDA) for urcosimod (formerly known as OK-101) for the treatment of neuropathic corneal pain, which is a debilitating condition affecting many tens of thousands worldwide, and is characterized by chronic, severe eye discomfort for which there is no FDA-approved, effective treatment.
“Fast track was first introduced by FDA to expedite development and review of drugs to treat serious conditions lacking any FDA-approved drug,” commented Gary S. Jacob, Ph.D., Chief Executive Officer of OKYO Pharma. “Notably, neuropathic corneal pain falls into this category, and our application for Fast Track designation marks a significant milestone in our commitment to addressing the urgent needs of patients suffering from this type of pain. It is our belief that urcosimod has the potential to redefine the treatment paradigm for individuals grappling with this challenging condition.”
About FDA Fast Track Designation
At this stage of development, a drug that receives Fast Track designation is eligible for some or all of the following:
- More frequent meetings with FDA to discuss the drug’s development plan, ensure collection of appropriate data needed to support drug approval, plus the use of a rolling FDA review to expedite its regulatory path.
- Quicker turnaround on written communication from FDA regarding such things as the design of the proposed clinical trials and potential use of biomarkers.
For more information on fast track designation: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
About NCP
Neuropathic corneal pain is a condition that causes severe pain and sensitivity of the eyes, face, or head. The exact cause of neuropathic corneal pain is unknown but is thought to result from nerve damage to the cornea combined with inflammation. Neuropathic corneal pain, which can exhibit as a severe, chronic, debilitating condition in patients suffering from a host of ophthalmic conditions, is presently treated by various topical and systemic treatments in an off-label fashion. Notably, there is no FDA approved drug to treat this debilitating condition.
About Urcosimod (Formerly called OK-101)
Urcosimod is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response, as well as on neurons and glial cells in the dorsal root ganglion. Urcosimod was developed using a membrane-anchored-peptide technology to produce a novel long-acting drug candidate for treating dry eye disease. Urcosimod has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and corneal neuropathic pain, respectively, and is designed to combat washout through the inclusion of the lipid anchor built into the drug molecule to potentially enhance the residence time of urcosimod within the ocular environment. Urcosimod showed clear statistical significance in multiple endpoints in a recently completed Phase 2, multi-center, double-masked, placebo-controlled trial to treat dry eye disease, and is presently being evaluated in a randomized, placebo-controlled, double-masked Phase 2 trial to treat 48 neuropathic corneal pain patients.
About OKYO
OKYO Pharma Limited (NASDAQ: OKYO) is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain and dry eye disease, with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO is focused on the discovery and development of novel molecules to treat neuropathic corneal pain and dry eye disease. In addition to the completed Phase 2 trial of urcosimod to treat dry eye disease patients, OKYO is also currently evaluating urcosimod to treat neuropathic corneal pain patients in a Phase 2 trial.
For further information, please visit www.okyopharma.com.
Enquiries:
| OKYO Pharma Limited | Gary S. Jacob, Chief Executive Officer | 917-497-7560 |
| Business Development & Investor Relations | Paul Spencer | +44 (0)20 7495 2379 |
FAQ
What is the purpose of OKYO's Fast Track designation application for urcosimod?
What medical conditions will OKYO's urcosimod target?
How many people are affected by neuropathic corneal pain that OKYO's urcosimod aims to treat?
What was urcosimod previously known as in OKYO's development pipeline?
