OKYO Pharma Announces New Data Showing Favorable Corneal Nerve Outcomes in Phase 2 Study for Neuropathic Corneal Pain

Rhea-AI Summary

OKYO Pharma (NASDAQ: OKYO) reported new analyses from its placebo-controlled, randomized, double-masked Phase 2 trial of 0.05% urcosimod in neuropathic corneal pain (NCP) on Dec 11, 2025. The 18-patient trial's exploratory corneal nerve imaging (in vivo confocal microscopy) showed median increases for 0.05% patients in total nerve fiber count (+2.0 n/0.16 mm², IQR 0.54–3.63) and total nerve fiber length (+2.6 mm/mm², IQR 1.55–5.67; p = 0.057 vs placebo).

The placebo group showed median decreases in nerve count (–1.92 n/0.16 mm², IQR –2.79 to –0.04) and length (–1.63 mm/mm², IQR –3.76 to 0.63). Results are described as exploratory (n = 4 per reported median) and presented as directionally favorable for corneal nerve structure, supporting further investigation.

Positive

• Median nerve fiber count +2.0 n/0.16 mm² for 0.05% urcosimod
• Median nerve fiber length +2.6 mm/mm² for 0.05% urcosimod
• Placebo group showed median decreases in both nerve metrics

Negative

• Small Phase 2 sample: 18 patients with medians reported on n = 4
• Primary exploratory endpoint not statistically significant: p = 0.057 vs placebo

Key Figures

Dose level 0.05% urcosimod Treatment arm in Phase 2 neuropathic corneal pain trial

Trial size 18 patients Recently completed placebo-controlled Phase 2 NCP trial

Nerve fiber count change +2.0 n/0.16 mm² Median increase for 0.05% urcosimod-treated patients

Nerve fiber length change +2.6 mm/mm² Median increase for 0.05% urcosimod-treated patients

P-value vs placebo p = 0.057 Comparison of total nerve fiber length change

Placebo fiber count change –1.92 n/0.16 mm² Median change in placebo group

Placebo fiber length change –1.63 mm/mm² Median change in placebo group

Imaging sample n = 4 Number of patients contributing to median nerve imaging values

Market Reality Check

$2.06 Last Close

Volume Volume 54,368 is below the 20-day average of 141,104, suggesting limited pre-news positioning. low

Technical Price at $2.02, trading slightly below the 200-day MA of $2.06 and well under the $3.349 52-week high.

Peers on Argus

OKYO was up 2.54% pre-news. Several biotech peers (e.g., STRO, ATRA, XBIT) also showed gains, but no names appeared on the momentum scanner, indicating stock-specific rather than broad sector-driven activity.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 03	Insider share purchase	Positive	-5.8%	Chairman-related entity acquired 27,051 shares, increasing total holdings.
Nov 21	Insider share purchase	Positive	+11.0%	Chairman-related entity bought 82,018 shares, boosting beneficial ownership.
Nov 18	Conference presentation	Positive	-0.7%	CEO to present urcosimod and Phase 2 data at OIS XV in San Diego.
Oct 29	Conference presentation	Positive	+6.7%	BIO-Europe presentation highlighting urcosimod Phase 2 NCP data and milestones.
Oct 16	Insider share purchase	Positive	+1.9%	Chairman-related entity acquired 210,000 shares, lifting total holdings.

Pattern Detected

Stock often reacts positively to strategic/clinical updates, while insider buying has produced mixed short-term reactions.

Recent Company History

Over the last few months, OKYO has focused investor attention on urcosimod and insider accumulation. On Oct 16, insider share purchases coincided with a modest gain, followed by a stronger move after the Oct 29 BIO-Europe presentation featuring recent Phase 2 data. Subsequent clinical and conference updates in November produced mixed price reactions. The latest chairman share purchase on Dec 3 saw a short-term decline, underscoring that insider buying has not consistently driven immediate upside.

Market Pulse Summary

The stock moved +6.9% in the session following this news. A strong positive reaction aligns with prior clinical-trial headlines that have often driven meaningful moves, as seen around earlier urcosimod updates. However, the dataset here is exploratory with small imaging samples, which can limit durability of enthusiasm. Without clear regulatory changes or capital structure shifts, attention would likely focus on how fast the company advances into larger trials and whether subsequent data replicate these nerve-structure signals.

Key Terms

neuropathic corneal pain medical

"urcosimod in neuropathic corneal pain (NCP). Patients treated with 0.05%"

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.

in vivo confocal microscopy medical

"Corneal nerve imaging data from the Phase 2 NCP trial were analyzed using in vivo confocal microscopy"

A high-resolution imaging technique that lets clinicians look at living tissue one tiny layer at a time, producing near-microscopic pictures without removing samples. Think of it as a powerful magnifying flashlight that views cells inside the body in real time. Investors care because the technology underpins diagnostic devices, helps measure treatment effects in clinical trials, and can drive sales or regulatory milestones for companies making imaging equipment and related therapies.

exploratory endpoint medical

"Data compiled from nerve growth analyses that were an exploratory endpoint in the recently completed"

An exploratory endpoint is a secondary measure in a clinical study used to gather additional information about a treatment’s effects beyond the main goals. Think of it as extra data points or a scout’s report that can suggest new benefits, risks, or ways to use a medicine but are not usually strong enough on their own to win regulatory approval. Investors watch these results because promising exploratory findings can increase a drug’s future value by guiding larger trials, new indications, or licensing opportunities, while also carrying more uncertainty than primary outcomes.

inter quartile range technical

"All values represent median (n = 4). * IQR = (Inter Quartile Range)"

The interquartile range is a measure of how spread out the middle 50% of a set of numbers is: it equals the value at the 75th percentile minus the value at the 25th percentile. For investors, it highlights the typical variation or consistency in data — for example returns, analyst estimates, or earnings — by focusing on the central band and ignoring extreme outliers, much like looking at the crowd’s middle instead of the very tallest or shortest people.

chemerin receptor pathway medical

"targeting the chemerin receptor pathway may open a new therapeutic avenue"

The chemerin receptor pathway is a biological signaling route where the protein chemerin binds to specific cell surface receptors to send messages that control inflammation, immune cell movement and metabolism. For investors, it matters because drugs or diagnostics that change this signaling can alter disease processes — like chronic inflammation, metabolic disorders or certain cancers — much like fixing a faulty traffic signal can ease congestion and improve flow.

AI-generated analysis. Not financial advice.

• Patients treated with 0.05% urcosimod demonstrated directionally favorable improvements in nerve fiber count and fiber length, trends not observed in the placebo group
• These findings suggest that urcosimod may have a positive impact on corneal nerve health in patients with neuropathic corneal pain
• Corneal nerve imaging data from the Phase 2 NCP trial were analyzed using in vivo confocal microscopy

LONDON and NEW YORK, Dec. 11, 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, is pleased to announce new analyses of corneal images from the recently completed placebo-controlled, randomized, double-masked, Phase 2 clinical trial of urcosimod in neuropathic corneal pain (NCP). Patients treated with 0.05% urcosimod demonstrated not only a positive reduction in neuropathic corneal pain, but also favorable changes in corneal nerve structure which were not observed in the placebo group.

Data compiled from nerve growth analyses that were an exploratory endpoint in the recently completed 18-patient trial of urcosimod demonstrated a favorable impact on corneal nerve health. Patients treated with 0.05% urcosimod showed median increases in total nerve fiber count (+2.0, n/0.16 mm², IQR 0.54 to 3.63) and total nerve fiber length (+2.6 mm/mm², IQR 1.55 to 5.67; p = 0.057 vs placebo). In contrast, the placebo group exhibited median decreases in total nerve fiber count (–1.92, n/0.16 mm², IQR –2.79 to –0.04) and total nerve fiber length (–1.63 mm/mm², IQR –3.76 to 0.63). This exploratory dataset, exhibiting consistent and meaningful directional improvements for 0.05% patients on urcosimod across key anatomical endpoints, highlights urcosimod’s potential to support corneal nerve restoration and reinforces its promise as a first-in-class therapeutic approach for neuropathic corneal pain that warrants further investigations. All values represent median (n = 4).

* IQR = (Inter Quartile Range)

“These early nerve regeneration signals are highly encouraging and biologically meaningful,” said Pedram Hamrah, MD, FARVO, Principal Investigator, and currently Professor of Ophthalmology at University of South Florida. “The fact that we are seeing consistent directional improvements in both nerve fiber count and nerve fiber length, suggests that urcosimod may not only reduce pain but also support the restoration of corneal nerve architecture. This represents an important step toward establishing additional mechanistic insights for urcosimod in NCP.”

“These results provide early evidence that urcosimod may help restore corneal nerve structure in patients suffering from neuropathic corneal pain,” said Raj Patil, PhD, Chief Scientific Officer of OKYO Pharma. “While exploratory, these findings reinforce our long-standing belief that targeting the chemerin receptor pathway may open a new therapeutic avenue for patients with neuropathic corneal pain. We are encouraged by the biological activity observed and believe they provide an important foundation for the continued development of urcosimod.”

About Neuropathic Corneal Pain (NCP)
NCP is a condition that causes severe pain and sensitivity of the eyes, face, or head. The exact cause of NCP is unknown but is thought to result from nerve damage to the cornea combined with inflammation. NCP, which can exhibit as a severe, chronic, debilitating condition in patients suffering from a host of ophthalmic conditions, is presently treated, with limited success by various topical and systemic treatments in an off-label fashion. There is presently no FDA-approved drug to treat NCP.

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 corneal neuropathic pain mouse model, respectively. 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, and 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.

About OKYO
OKYO Pharma Limited (NASDAQ: OKYO) is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain, 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 is currently planning a second larger, multicenter trial of urcosimod in NCP patients that is planned to start in Q1 2026.

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

Enquiries:

OKYO Pharma Limited	Gary S. Jacob, Chief Executive Officer	+44 (0)20 7495 2379
Business Development & Investor Relations	Paul Spencer	+44 (0)20 7495 2379

FAQ

What did OKYO announce about urcosimod corneal nerve data on Dec 11, 2025?

OKYO reported exploratory Phase 2 imaging showing directionally favorable median increases in nerve fiber count (+2.0 n/0.16 mm²) and length (+2.6 mm/mm²) for 0.05% urcosimod versus placebo.

How many patients were in OKYO's Phase 2 urcosimod NCP trial (OKYO)?

The trial enrolled 18 patients, with reported medians based on n = 4 for the imaging endpoints.

Were OKYO's corneal nerve improvements statistically significant in the Phase 2 OKYO study?

The reported comparison for nerve fiber length versus placebo had a p = 0.057, which the company describes as exploratory and directionally favorable.

What imaging method did OKYO use to assess corneal nerves in the OKYO trial?

Corneal images were analyzed using in vivo confocal microscopy as an exploratory endpoint.

What do OKYO's Phase 2 nerve results imply for future development of urcosimod (OKYO)?

The company presents the results as early, biologically meaningful signals that may support further clinical investigation of urcosimod for neuropathic corneal pain.