OKYO Pharma Announces Acceptance of Urcosimod Phase 2 Study Results for Presentation at Prestigious ASCRS Annual Meeting

OKYO Pharma (Nasdaq: OKYO) announced acceptance of a Phase 2 urcosimod abstract for presentation at the 2026 ASCRS Annual Meeting on April 11, 2026 in Washington, DC.

Rhea-AI Summary

OKYO Pharma (Nasdaq: OKYO) announced acceptance of a Phase 2 urcosimod abstract for presentation at the 2026 ASCRS Annual Meeting on April 11, 2026 in Washington, DC. The abstract reports efficacy and safety results from a proof-of-concept pilot Phase 2 study, including pain reduction and corneal nerve health trends.

The company notes urcosimod previously received the first IND to treat NCP and FDA fast track designation, and expects to initiate a 150-patient Phase 2b/3 multiple-dose study in the first half of 2026.

Positive

• Abstract accepted for presentation at ASCRS 2026 on April 11, 2026
• First IND granted to treat neuropathic corneal pain
• Drug awarded FDA fast track designation
• Planned initiation of a 150-patient Phase 2b/3 multiple-dose study in H1 2026
• Proof-of-concept Phase 2 showed efficacy signals including meaningful pain reduction and corneal nerve health trends

Negative

• Results are from a proof-of-concept pilot Phase 2 and are therefore preliminary
• No detailed quantitative efficacy or safety figures disclosed in this announcement

Argus Jan 30 session

+0.49% close to close Open Argus

Details

News Market Reaction – OKYO

On Jan 30, the day this news came out, OKYO closed 0.49% above the previous close.

Data tracked by StockTitan Argus for the Jan 30 session.

Market Context

This announcement highlights peer-reviewed recognition of urcosimod’s Phase 2 neuropathic corneal pa...

Analysis

This announcement highlights peer-reviewed recognition of urcosimod’s Phase 2 neuropathic corneal pain data via acceptance at the 2026 ASCRS Annual Meeting, alongside plans for a 150-patient Phase 2b/3 trial in the first half of 2026. Historically, clinical-trial news for urcosimod has been followed by positive stock moves averaging 9.53%. Investors may watch for the full ASCRS presentation, detailed Phase 2b/3 design, enrollment progress, and any additional safety or efficacy disclosures as key next checkpoints.

Key Figures

Planned trial size: 150 patients Session time: 3:30 PM–5:00 PM Meeting date: April 11, 2026 +1 more

Planned trial size

150 patients

Planned Phase 2b/3 multiple-dose NCP study in first half of 2026

Session time

3:30 PM–5:00 PM

ASCRS Ocular Surface Disease II session on April 11, 2026

Meeting date

April 11, 2026

Presentation of Phase 2 urcosimod results at ASCRS Annual Meeting

Study phase

Phase 2b/3

Planned larger multiple-dose NCP trial building on Phase 2 data

Previous Clinical trial Reports

5 past events · Latest: Dec 11

Same Type 5 events

1. Dec 11

   Phase 2 nerve data

   24h Move

   +6.9%

   New analyses showed directionally favorable corneal nerve outcomes in Phase 2 trial.

2. Sep 22

   Expanded trial plan

   24h Move

   +13.6%

   Announced 100-patient multi-center trial following strong Phase 2 pain reduction data.

3. Jul 16

   Phase 2 results

   24h Move

   +7.6%

   Reported statistically significant Phase 2 pain reduction and no serious adverse events.

4. Apr 30

   Development acceleration

   24h Move

   +0.0%

   Closed Phase 2 early to analyze data and move toward a multicenter trial.

5. Oct 23

   First patient dosed

   24h Move

   +19.4%

   Initiated Phase 2 trial with first patient dosing in NCP indication.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

neuropathic corneal pain, fast track designation, investigational new drug (ind), phase 2b/3

4 terms

neuropathic corneal pain medical

"developing investigational therapies for the treatment of neuropathic corneal pain (NCP)"

Neuropathic corneal pain is chronic, often severe eye pain caused by damage or malfunction in the tiny nerves of the cornea, where the eye surface can feel burning, stinging, or like something is in it despite little visible damage. It matters to investors because it represents a persistent, hard-to-treat medical need that drives demand for new drugs, diagnostics, devices and regulatory approvals, similar to how fixing a frayed electrical wire stops false alarm signals.

fast track designation regulatory

"was awarded fast track designation by the Food and Drug Administration (FDA)"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

investigational new drug (ind) regulatory

"urcosimod was granted the first IND to treat patients with NCP"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

phase 2b/3 medical

"toward a planned larger Phase 2b/3 trial in the first half of 2026"

A phase 2b/3 trial is a combined late-stage clinical study that first refines the best dose and measures how well a treatment works (phase 2b) then expands to a larger, definitive test of safety and effectiveness needed for regulatory approval (phase 3). For investors, results from a phase 2b/3 act like a dress rehearsal that turns into opening night: positive, well-controlled outcomes substantially raise the chance of approval and future sales, while failures can sharply reduce a drug’s value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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LONDON and NEW YORK, Jan. 30, 2026 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company developing investigational therapies for the treatment of neuropathic corneal pain (NCP) and for inflammatory eye diseases, today announces that an abstract on its lead candidate, urcosimod (formerly OK-101), has been accepted for presentation at the prestigious 2026 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting.

The accepted paper, titled "Evaluation of Urcosimod in Neuropathic Corneal Pain: Efficacy and Safety Results from a Proof-of-Concept Pilot Phase 2 Study", will be presented in the Ocular Surface Disease II session on Saturday, April 11, 2026, from 3:30 PM to 5:00 PM at the meeting in Washington, DC.

This acceptance follows a rigorous and highly competitive review process by the ASCRS Annual Meeting Program Committee, where only a limited number of submissions are selected each year. The abstract highlights efficacy and safety data from OKYO's recently completed proof-of-concept Phase 2 study of urcosimod in patients with neuropathic corneal pain.

Robert Dempsey, Chief Executive Officer of OKYO Pharma, commented: "We are delighted to have our proof-of-concept Phase 2 data on urcosimod accepted for presentation at the prestigious 2026 ASCRS Annual Meeting. This recognition underscores the potential of urcosimod as a novel, first-in-class therapeutic for neuropathic corneal pain, a debilitating condition affecting patients with significant unmet need. Building on positive efficacy signals, including meaningful pain reduction and encouraging corneal nerve health trends from our study, this platform provides an important opportunity to share these results with leading ophthalmologists and advance our ongoing development efforts toward a planned larger Phase 2b/3 trial in the first half of 2026."

The ASCRS Annual Meeting is a premier gathering for anterior segment surgeons and ophthalmologists focused on cataract, refractive, cornea, and glaucoma innovations.

As previously communicated, urcosimod was granted the first IND to treat patients with NCP and was awarded fast track designation by the Food and Drug Administration (FDA). The company expects to initiate a 150-patient Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.

About Neuropathic Corneal Pain (NCP)

Neuropathic corneal pain (NCP) is a chronic, often debilitating condition characterized by severe pain and sensitivity of the eyes, and in some cases the face or head. It is thought to result from damage or dysfunction of corneal sensory nerves, often in combination with inflammatory processes, and may occur in patients with a range of underlying ophthalmic conditions. There are currently no FDA-approved therapies specifically for NCP, resulting in patients being treated with limited or no success using various topical and systemic medications in an off-label manner.

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 has been shown to produce anti-inflammatory and pain-reducing activities in a mouse model of dry eye disease and in a neuropathic corneal pain mouse model, respectively. OKYO recently announced positive data on NCP pain reduction in a randomized, placebo-controlled, double-masked Phase 2 trial involving 18 neuropathic corneal pain patients. Urcosimod showed clear statistical significance in multiple endpoints in an earlier 240-patient Phase 2, multi-center, double-masked, placebo-controlled trial to treat dry eye disease.

About OKYO Pharma

OKYO Pharma Limited (Nasdaq: OKYO) is a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP) and inflammatory eye diseases, 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 other ocular diseases. OKYO recently completed a successful phase 2 trial of its flagship drug urcosimod in patients with NCP and plans to initiate a 150-patient Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.

For further information, please visit www.okyopharma.com.

For further inquiries:

OKYO Pharma Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
Email: info@okyopharma.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When and where will OKYO (OKYO) present urcosimod Phase 2 results at ASCRS 2026?

OKYO will present on April 11, 2026, 3:30–5:00 PM in the Ocular Surface Disease II session. According to the company, the presentation is part of the ASCRS Annual Meeting in Washington, DC and follows competitive abstract selection.

What did OKYO report about urcosimod efficacy and safety from the Phase 2 study?

The company reported efficacy signals including meaningful pain reduction and encouraging corneal nerve health trends. According to OKYO, these findings come from a proof-of-concept pilot Phase 2 study and will be presented in detail at ASCRS.

Has urcosimod received any regulatory designations relevant to development?

Yes. Urcosimod received the first IND to treat NCP and was awarded FDA fast track designation. According to OKYO, these designations support an accelerated development pathway and regulatory engagement.

When does OKYO expect to start the larger Phase 2b/3 trial for urcosimod and what is its size?

OKYO expects to initiate a 150-patient Phase 2b/3 multiple-dose study in the first half of 2026. According to the company, the trial will expand evaluation of efficacy and safety in NCP patients.

What does ASCRS presentation acceptance mean for OKYO shareholders and development progress?

Acceptance signals peer recognition and greater visibility among ophthalmologists, potentially aiding clinical development and recruitment. According to OKYO, the presentation provides an opportunity to share Phase 2 data ahead of the planned Phase 2b/3 trial.