OKYO Abstract Selected for Presentation at Premier Global Ophthalmology Congress

Rhea-AI Summary

OKYO (Nasdaq: OKYO) announced that an abstract on urcosimod for neuropathic corneal pain (NCP) was accepted for presentation at ARVO 2026 (May 3-7, Denver).

OKYO reported Phase 2a proof-of-concept results showing clinically meaningful pain reduction (VAS), quality-of-life improvement, potential corneal nerve restoration, FDA Fast Track designation, IND clearance, and a planned ~150-patient Phase 2b/3 trial expected to start in the coming months.

Positive

• FDA Fast Track designation for urcosimod in NCP
• IND clearance specifically for NCP—the first candidate to receive it
• Phase 2a showed clinically meaningful VAS pain reduction and QoL improvements
• Planned ~150-patient Phase 2b/3 multicenter trial to further evaluate efficacy

Negative

• Efficacy evidence is limited to a Phase 2a proof-of-concept study pending larger confirmation
• Phase 2b/3 initiation is expected but not yet started, so timing remains uncertain

Key Figures

Planned Phase 2b/3 size: approximately 150 patients ARVO 2026 dates: May 3–7, 2026 First-in-human study: Neuropathic corneal pain patients +1 more

4 metrics

Planned Phase 2b/3 size approximately 150 patients Upcoming multicenter Phase 2b/3 urcosimod trial for NCP

ARVO 2026 dates May 3–7, 2026 Association for Research in Vision and Ophthalmology Annual Meeting

First-in-human study Neuropathic corneal pain patients Phase 2a proof-of-concept trial of urcosimod

Regulatory status FDA Fast Track and first IND for NCP Regulatory designations for urcosimod in NCP

Market Reality Check

Price: $1.70 Vol: Volume 258,802 vs. 20-day...

low vol

$1.70 Last Close

Volume Volume 258,802 vs. 20-day average 406,822 (relative volume 0.64) shows subdued trading ahead of this news. low

Technical Shares at $1.70 are trading below the 200-day MA ($2.25) and sit 49.24% under the 52-week high.

Peers on Argus

OKYO was down 3.41% while key biotech peers like IRD, STRO, OVID, and XBIT showe...

2 Up 1 Down

OKYO was down 3.41% while key biotech peers like IRD, STRO, OVID, and XBIT showed same-day declines between ~1.9% and ~6.1%, suggesting broader biotech pressure but not a tightly synchronized move with OKYO.

Common Catalyst Some peers (e.g., STRO, ATRA) also reported corporate or conference-related updates, indicating a flow of sector news rather than a single unifying catalyst.

Historical Context

5 past events · Latest: Feb 12 (Negative)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 12	Equity offering priced	Negative	+11.3%	Underwritten public offering priced at $1.85 raising about $20M.
Feb 12	Equity offering announced	Negative	+11.3%	Announcement of underwritten share offering under Form F-3 shelf.
Feb 11	ATM facility transition	Negative	-6.7%	Transition of ATM equity facility to Leerink Partners as sales agent.
Feb 10	New CMO appointment	Positive	+5.0%	Appointment of experienced CMO to lead urcosimod clinical strategy.
Jan 30	Phase 2 data abstract	Positive	+0.5%	Acceptance of urcosimod Phase 2 study results for ASCRS meeting.

Pattern Detected

Recent offerings and financing moves often produced mixed reactions, with some dilutive events seeing positive moves while the ATM shift drew a negative response. Leadership and clinical conference news have generally aligned with modestly positive price reactions.

Recent Company History

Over recent weeks, OKYO has focused on financing and advancing urcosimod. Multiple offerings and ATM program changes in February 2026 funded clinical development, with reactions split between gains and losses. Leadership strengthening on Feb 10 and acceptance of Phase 2 data for ASCRS on Jan 30 both drew modest positive responses. Today’s ARVO abstract acceptance continues the pattern of showcasing urcosimod data at major ophthalmology meetings while the company executes on its Phase 2b/3 plans.

Regulatory & Risk Context

Active S-3 Shelf · $200,000,000

Shelf Active

Active S-3 Shelf Registration 2026-02-02

$200,000,000 registered capacity

An effective Form F-3 shelf filed on Feb 2, 2026 allows OKYO to issue up to $200,000,000 of ordinary shares, warrants and units over time. The company has already used this shelf via multiple 424B5 offerings, highlighting reliance on equity financing while it advances urcosimod.

Market Pulse Summary

This announcement underscores continued validation for urcosimod, with first-in-human Phase 2a data ...

Analysis

This announcement underscores continued validation for urcosimod, with first-in-human Phase 2a data selected for presentation at ARVO 2026 and plans for an approximately 150-patient Phase 2b/3 trial. It extends a sequence of conference acceptances and leadership moves focused on neuropathic corneal pain. Investors may watch for concrete Phase 2b/3 initiation, additional clinical details from ARVO and ASCRS, and how ongoing use of the $200,000,000 shelf shapes the company’s funding path.

Key Terms

neuropathic corneal pain, visual analogue scale (vas), phase 2a, phase 2b/3, +2 more

6 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.

visual analogue scale (vas) medical

"reductions in pain—as measured by the Visual Analogue Scale (VAS)—along with improvements"

A visual analogue scale (VAS) is a simple patient-reported tool where someone marks their symptom severity along a straight line between two labeled endpoints (for example, “no pain” to “worst pain imaginable”). Investors pay attention because VAS scores are often used in clinical trials and patient studies to measure whether a treatment meaningfully changes symptoms; like a thermometer for feelings, the results can affect trial success, regulatory decisions, and market expectations.

phase 2a medical

"recently completed proof-of-concept Phase 2a clinical trial of urcosimod"

Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.

phase 2b/3 medical

"planned larger multicenter Phase 2b/3 trial (approximately 150 patients)"

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.

fda fast track designation regulatory

"Urcosimod holds FDA Fast Track designation for NCP"

FDA Fast Track designation is a U.S. regulatory status that gives a drug or treatment a faster, more interactive path through development and review because it targets a serious condition with unmet medical need. Think of it as a “fast lane” at the agency that can speed up testing and paperwork, potentially shortening the time to market; for investors, that can lower development risk and accelerate potential revenue, though it does not guarantee approval.

ind clearance regulatory

"first candidate to receive IND clearance specifically for this indication"

IND clearance is regulatory authorization that allows a company to begin testing an experimental drug in human clinical trials. Think of it as a safety-passport from regulators confirming enough preclinical evidence exists to move from lab work to people; for investors it marks a major development milestone that de-risks the program’s path to approval, unlocks value-driving data milestones, and often influences funding, partnerships, and stock value.

AI-generated analysis. Not financial advice.

LONDON and NEW YORK, Feb. 23, 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 announced that its abstract has been accepted for presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2026 Annual Meeting, taking place May 3-7, 2026, in Denver, Colorado.

Chief Scientific Officer Raj Patil, Ph.D., will share the data in a presentation titled: "First-in-Human Study of Urcosimod to Treat Neuropathic Corneal Pain (NCP) Shows Clinically Meaningful Pain Reduction and Quality-of-Life Improvement in NCP Patients."

This presentation highlights positive results from OKYO's recently completed proof-of-concept Phase 2a clinical trial of urcosimod, a novel, non-opioid, preservative-free eye-drop therapy with dual pain-relieving and anti-inflammatory activity for neuropathic corneal pain (NCP). The first-in-human study in NCP patients demonstrated clinically meaningful reductions in pain—as measured by the Visual Analogue Scale (VAS)—along with improvements in quality-of-life metrics. In addition, urcosimod demonstrated the potential to help restore corneal nerve structure in patients suffering from neuropathic corneal pain.

Neuropathic corneal pain is a debilitating chronic ocular condition characterized by severe nerve-related pain without visible surface damage and currently has no FDA-approved treatments. Urcosimod holds FDA Fast Track designation for NCP and is the first candidate to receive IND clearance specifically for this indication. Following encouraging Phase 2a proof-of-concept results, OKYO is advancing urcosimod into a planned larger multicenter Phase 2b/3 trial (approximately 150 patients) to further evaluate its efficacy and safety, with initiation expected in the coming months.

“We are honored that our urcosimod data has been selected for presentation at ARVO 2026, one of the world’s leading forums for vision and ophthalmology research,” said Raj Patil, Ph.D., Chief Scientific Officer of OKYO Pharma. “These first-in-human results underscore urcosimod's potential to address a significant unmet need in NCP by providing meaningful pain relief and enhancing patients' quality of life. We look forward to sharing these findings with the scientific community and continuing to advance this promising therapy.”

The ARVO Annual Meeting attracts thousands of leading researchers, clinicians, and industry professionals focused on advancing eye and vision science.

As previously announced, urcosimod was granted the first IND application for the treatment of patients with NCP and was awarded fast track designation by the Food and Drug Administration (FDA). The company expects to initiate a ~150 subject 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 2a trial involving 18 neuropathic corneal pain subjects. Urcosimod has shown significant pain reduction in an earlier 240 subject Phase 2, multi-center, double-masked, placebo-controlled trial in DED, which supports the development rationale in NCP.

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 subjects with NCP and plans to initiate a ~150 subject 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.

Forward-Looking Statements

Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. These and additional risks and uncertainties are described more fully in the company’s filings with the SEC, including those factors identified as “Risk Factors” in our most recent Annual Report on Form 20-F, for the fiscal year ended March 31, 2025. The company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements, except as may be required by law.

For further inquiries:

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

FAQ

What did OKYO (OKYO) announce about urcosimod at ARVO 2026 on February 23, 2026?

OKYO announced its abstract was accepted for ARVO 2026 and will present Phase 2a urcosimod data. According to the company, the first-in-human study showed clinically meaningful pain reduction, quality-of-life gains, and potential corneal nerve structure improvement.

Does urcosimod have any FDA designations or clearances for NCP (OKYO)?

Yes. According to the company, urcosimod holds FDA Fast Track designation and was the first to receive IND clearance specifically for NCP. These regulatory recognitions may speed development and regulatory engagement for this indication.

What were the Phase 2a results for urcosimod reported by OKYO (OKYO)?

The Phase 2a first-in-human study reported clinically meaningful reductions in pain measured by VAS and improved quality of life. According to the company, urcosimod also showed potential to help restore corneal nerve structure in NCP patients.

When will OKYO start the Phase 2b/3 trial for urcosimod and how large will it be?

OKYO plans to initiate a multicenter Phase 2b/3 trial in the coming months, targeting approximately 150 patients. According to the company, the study is a multiple-dose trial intended to further evaluate efficacy and safety.

What does ARVO 2026 presentation mean for OKYO (OKYO) and investors?

The ARVO presentation provides scientific visibility and peer exposure for urcosimod's Phase 2a data. According to the company, sharing results at a major ophthalmology forum supports clinical validation and engagement with researchers and clinicians.