Corneal Ulcer Pipeline Insight 2025: 15+ Emerging Anti-Infective and Regenerative Therapies Targeting Sight-Threatening Infections | DelveInsight

DelveInsight's "Corneal Ulcer - Pipeline Insight, 2025" report offers a detailed overview of the therapeutic advancements underway for corneal ulcers, a serious ocular condition often caused by bacterial, viral, fungal, or parasitic infections. Left untreated, corneal ulcers can lead to scarring, vision impairment, or even blindness, making timely intervention and effective therapy critical.

The current pipeline features a growing number of targeted anti-infectives, corticosteroid formulations, and regenerative approaches aimed at addressing the underlying infection while promoting epithelial repair. With increasing cases of antimicrobial resistance and complications from delayed diagnosis, there is a pressing need for more effective, fast-acting treatments that go beyond conventional antibiotic or antifungal eye drops.

Key therapies in development include APP13007 by Formosa Pharmaceuticals, a Phase III corticosteroid nanoparticle formulation, and RGN-259 by RegeneRx, a thymosin beta-4-based eye drop being studied for both infectious keratitis and epithelial healing. Several other candidates, including bioactive peptides and stem cell-based therapies, are in early clinical stages, reflecting a shift toward multi-modal, tissue-protective strategies.

Biopharma companies such as Formosa, RegeneRx, Dompé, and FiteBac are actively shaping the space, leveraging orphan drug designations and novel delivery technologies to accelerate development. As innovation intensifies, the corneal ulcer pipeline shows strong potential to deliver next-generation solutions for this vision-threatening condition.

Interested in learning more about the current treatment landscape and the key drivers shaping the corneal ulcer pipeline? Click here: https://www.delveinsight.com/report-store/corneal-ulcer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Corneal Ulcer Pipeline Report
• DelveInsight's corneal ulcer pipeline analysis depicts a strong space with 15+ active players working to develop 15+ pipeline drugs for corneal ulcer treatment.
• The leading corneal ulcer companies include OcuNexus Therapeutics, Recordati Rare Diseases, Santen S.A.S., FirstString Research, Regeneratetx, Stuart Therapeutics, EyeGate Pharmaceuticals, Trefoil Therapeutics, AmebaGone Inc, Dobecure, Editas Medicine, and others are evaluating their lead assets to improve the corneal ulcer treatment landscape.
• Key corneal ulcer pipeline therapies in various stages of development include MPC-06-ID, LY3016859, PP353, CordSTEM-DD, ALLOD 2, STA 363, XG005, SX600, CAM2038, and others.
• In May 2025, the FDA granted Fast Track designation to urcosimod (OKYO Pharma) for treating neuropathic corneal pain, which often accompanies chronic epithelial defects and ulcerative conditions. The Phase 2b trial began dosing in October 2024
• In May 2025, Blue Cross Blue Shield guidelines reaffirmed approval of cenegermin‐bkjl (Oxervate®)-recombinant human nerve growth factor-for neurotrophic keratitis, a condition that can result in persistent corneal ulcers. Originally FDA-approved in August 2018 with orphan status
• In February 2025, the FDA issued a Day‐74 letter accepting the NDA for Epioxa (epi‐on corneal cross‐linking) from Glaukos, with a PDUFA target date of October 20, 2025. Epioxa represents the first non‐invasive, epi‐on drug/device therapy intended to strengthen corneal tissue in keratoconus and potentially related ulcerative complications

Request a sample and discover the recent breakthroughs happening in the corneal ulcer pipeline landscape at https://www.delveinsight.com/report-store/corneal-ulcer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Corneal Ulcer Overview
A corneal ulcer is an open sore on the cornea, the clear front surface of the eye. It is most commonly caused by infections-bacterial, viral, fungal, or parasitic-but can also result from eye injuries, contact lens misuse, or severe dry eye. Symptoms typically include eye redness, pain, tearing, blurred vision, light sensitivity, and a visible white spot on the cornea. If left untreated, corneal ulcers can lead to serious complications, including vision loss or blindness. Treatment depends on the underlying cause and often involves antibiotic, antifungal, or antiviral eye drops. In severe cases, surgery such as corneal transplantation may be necessary. Early diagnosis and prompt treatment are crucial for preserving vision.

Find out more about corneal ulcer medication at https://www.delveinsight.com/report-store/corneal-ulcer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Corneal Ulcer Treatment Analysis: Drug Profile
CODA001: OcuNexus Therapeutics
CODA001 is an antisense oligonucleotide that downregulates connexin 43 (Cx43), a gap junction protein elevated in persistent epithelial defects. Originally developed by CODA Therapeutics and now in Phase II under OcuNexus, the drug has shown promise in patients with severe ocular surface burns. In a study by Ormonde et al., five refractory cases were treated using Cx43-specific antisense oligonucleotides in Poloxamer407 gel, resulting in reduced inflammation within 1-2 days and complete corneal reepithelialization.

Synthetic FGF Inhibitors: Dobecure
Dobecure is developing synthetic fibroblast growth factor (FGF) inhibitors for conditions like age-related macular degeneration (wet and dry), uveitis, corneal edema, herpetic keratitis, and more. The drug is currently in Phase I development, targeting inflammatory and degenerative eye disorders.

Learn more about the novel and emerging corneal ulcer pipeline therapies at https://www.delveinsight.com/report-store/corneal-ulcer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Corneal Ulcer Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Infusion
• Intradermal
• Intramuscular
• Intravenous
• Oral
• Parenteral
• Subcutaneous
• Topical

By Molecule Type
• Gene therapies
• Small molecule
• Vaccines
• Polymers
• Peptides
• Monoclonal antibodies

Scope of the Corneal Ulcer Pipeline Report
• Coverage: Global
• Key Corneal Ulcer Companies: OcuNexus Therapeutics, Recordati Rare Diseases, Santen S.A.S., FirstString Research, Regeneratetx, Stuart Therapeutics, EyeGate Pharmaceuticals, Trefoil Therapeutics, AmebaGone Inc, Dobecure, Editas Medicine, and others.
• Key Corneal Ulcer Pipeline Therapies: MPC-06-ID, LY3016859, PP353, CordSTEM-DD, ALLOD 2, STA 363, XG005, SX600, CAM2038, and others.

To dive deep into rich insights for drugs used for corneal ulcer treatment, visit: https://www.delveinsight.com/report-store/corneal-ulcer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Corneal Ulcer Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Corneal Ulcer Pipeline Therapeutics
6. Corneal Ulcer Pipeline: Late-Stage Products (Phase III)
7. Corneal Ulcer Pipeline: Mid-Stage Products (Phase II)
8. Corneal Ulcer Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform, PharmDelve.

This release was published on openPR.