Good Afternoon Market Enthusiast,

Markets were leaning green today and attention is snapping back to names with real data, a clear plan, and delivery you can explain without a lab coat. Eye care fits that bill. The daily burden is huge, the path to scale is easy to grasp, and people feel it every day. 

That is why OKYO Pharma Limited (OKYO) should be on your screen today. 👁️

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OKYO at a glance (4)(5)(11)(15)

OKYO does what many clinical names do not. They communicate clearly. The site is clean, the science is easy to follow, and the path forward is mapped in plain language.

The company is focused on Dry Eye Disease and neuropathic corneal pain. Both are common, painful, and poorly served by current options.

The lead program is urcosimod, a topical candidate that aims to calm surface inflammation and pain. It was previously known as OK 101 and received its United States Adopted Name in February. 🧪🔬

Market backdrop (5)

Dry Eye Disease is large and visible. It has been projected to reach $6.57 Billion by 2027. In the United States there are about 38 million cases.

Worldwide about 700 million.

It affects more than 35% of people over fifty.

About two thirds of patients are women. Even modest clinical differentiation in this setting can translate into meaningful real world use. Add a topical route and the product story becomes simple for clinicians, payors, and patients. 👁️✅

Company insight (5)(10)

The company initiated a Phase 2 trial of urcosimod in Dry Eye Disease in May of 2023. Topline readout in January of the following year was described as extremely encouraging. Urcosimod showed a highly favorable tolerability profile and reached statistical significance on multiple endpoints covering signs and symptoms. That includes total conjunctival staining as a sign of disease and improvements in burning and stinging as well as blurred vision. The company has stated that to their knowledge no approved Dry Eye Disease drug has shown improvement in conjunctival staining in clinical studies. Differentiation on a sign endpoint paired with symptom relief is exactly what clinicians like to see. 🧠📊

With those data, OKYO is preparing to advance urcosimod into Phase 3 in Dry Eye Disease with the stated goal of delivering a highly differentiated dry eye product for patients who remain underserved. ⚙️

A second lane with urgency (6)(12)(14)(15)

Signals also emerged in neuropathic corneal pain. This is a severe chronic condition with no approved commercial treatments today. The Food and Drug Administration cleared OK 101 as the first Investigational New Drug application for neuropathic corneal pain in February. A Phase 2 trial began in October led by Dr. Pedram Hamrah at Tufts Medical Center, a recognized expert in this domain.

Momentum picked up this spring. On April 30 the company closed the neuropathic corneal pain Phase 2 trial early to access masked data and plan an expanded development program. Patients requested compassionate use. Leadership emphasized that this decision shortens the path to an end of Phase 2 meeting with the agency.

The next day the program received Fast Track Designation for neuropathic corneal pain. Fast Track allows more frequent FDA touchpoints and can enable Accelerated Approval, Priority Review, and Rolling Review if criteria are met. Shortly after, the company reported strong Phase 2 results. At the 0.5% dose, 75% of patients in a defined group achieved greater than 80% reduction in pain severity on a Visual Analogue Scale. In a setting with no approved therapies, that kind of signal draws attention. 🧾

September 22 update (1)(7)(15)

OKYO detailed the registration pathway for urcosimod in neuropathic corneal pain. The next study is a randomized, placebo controlled, double masked multiple ascending dose trial targeting about 100 patients at U.S. sites. Objectives include selecting the registration dose, aligning with FDA on the primary endpoint, and expanding understanding of the micellar formulation. Site negotiations are underway with topline data targeted in 2026. Urcosimod holds Fast Track, supporting quicker FDA touchpoints. 🇺🇸📊⏱️

OKYO also received $1.9 million in non dilutive funding to support research and development. The team highlighted use of proceeds to advance clinical milestones and maintain momentum on the regulatory path. Alignment shows up in insider behavior as well. The CEO purchased ten thousand shares in January. ✅

How the market has reacted so far (1)(2)(3)

When we last spotlighted OKYO the name saw an intraday move of almost 18%. Over the past year the company is up more than 95%. Nearly 80% of that move arrived in the past six months. That curve shows acceleration. ⚡

Coverage is expanding. Current work from analysts points to an average target of $10 and a high target of $13. From current levels those imply about 400% and about 550% respectively. Targets are models, not guarantees, but they frame how professionals see the path if clinical and regulatory steps continue to line up. 🎯

Why the story resonates (5)(7)(12)(15)(17)

Two active indications. One topical mechanism tuned to inflammation and pain. A sign endpoint in Dry Eye Disease that sets urcosimod apart. A high need pain condition with Fast Track status. An early trial closure to accelerate planning. Patient requests for continued access. Non dilutive support to keep the cadence. 👁️🧪🧠

Catalysts on the near horizon

Only a short list so you can scan fast.

• FDA meeting to define the primary endpoint for neuropathic corneal pain
• Site activation and first patient in for the one hundred patient NCP study
• Dose selection updates or safety summaries as available
• Phase 3 initiation planning and design details in Dry Eye Disease
• Additional data analyses including durability and responder distribution
• Clinician presentations and peer reviewed updates that lift awareness
• Funding or partnership updates that match the unmet need

Why now (1)(3)(5)(12)(14)(15)

Strong markets amplify names with concrete steps and visible timelines. OKYO has both. Data in Dry Eye Disease that pair signs and symptoms. A unique sign improvement claim noted by the company. A parallel path in neuropathic corneal pain with Fast Track and deep pain reductions at a low dose. Leadership moving with urgency. Patient demand visible in compassionate use requests. 

The September 22nd plan locks in scale for neuropathic corneal pain, adds a 2,026 data marker, and keeps Fast Track momentum aimed at registration.

Add performance context. Our prior highlight aligned with a near 18% percent intraday surge. The one year climb is above 95% percent and most of that came in the past six months which points to acceleration. Analysts now cluster around $10 on average with a $13 high watermark which implies very large upside from here if the plan stays on track.

Bottom line

OKYO is taking a clear shot at two high need conditions with a topical candidate that has shown strong signals across both signs and symptoms. 

The pathway is defined. 

The calendar is filling in. 

The communication is clear. 

In a market that rewards clarity and delivery, this combination can travel. 👁️⚡

Check out OKYO today ✅

To your success,

Max Masters

Co-founder, Market Tips Newsletter

Sources:
1. https://finance.yahoo.com/quote/OKYO/ 
2. https://finance.yahoo.com/quote/OKYO/key-statistics/
3. https://finance.yahoo.com/quote/OKYO/history/ 
4. https://okyopharma.com/
5. https://okyopharma.com/wp-content/uploads/2024/07/OKYO-Slide-Deck-for-July.pdf
6. https://okyopharma.com/wp-content/uploads/2025/02/OKYO-FEB-25-Phase-2a-Trial-in-NCP-to-Complete-Enrollment-in-2Q25-Reiter.pdf
7.  https://bit.ly/45jdShe
8. https://www.ophthalmologymanagement.com/news/2025/okyo-pharma-to-complete-enrollment-of-neuropathic-corneal-pain-trial-by-end-of-q2/
9. https://www.biopharmadive.com/news/aerie-pharmaceuticals-alcon-deal-glaucoma/630267/
10. https://okyopharma.com/wp-content/uploads/2023/09/OKYO_Enrollment-PR_FINAL_GJ.pdf
11. https://okyopharma.com/technology/
12. https://glance.eyesoneyecare.com/stories/2025-05-05/fda-grants-fast-track-designation-to-okyo-pharma-s-ncp-therapeutic/
13. https://glance.eyesoneyecare.com/stories/2025-04-02/okyo-s-urcosimod-demonstrates-long-term-stability-for-ncp/
14. https://bit.ly/3FI1jSd
15. https://finance.yahoo.com/news/okyo-pharma-announces-registration-pathway-123000467.html

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