Neurotrophic Keratitis Pipeline Insight 2025: Targeting Corneal Healing and Nerve Regeneration for Long-Term Ocular Surface Restoration | DelveInsight

Neurotrophic keratitis (NK), a rare degenerative corneal disease caused by trigeminal nerve dysfunction, poses significant challenges in ophthalmic care due to its chronic, progressive nature and poor corneal healing. Characterized by reduced or absent corneal sensitivity, persistent epithelial defects, and risk of corneal ulceration and perforation, NK remains an area with limited therapeutic options and a high unmet need.

DelveInsight's "Neurotrophic Keratitis - Pipeline Insight, 2025" analyzes a growing pipeline of 3+ emerging therapies that aim to restore corneal integrity by promoting nerve regeneration, epithelial healing, and ocular surface homeostasis.

The pipeline features recombinant human nerve growth factors (rhNGF), neuropeptide-based therapies, regenerative biologics, and gene therapy candidates, targeting both the root cause and downstream effects of NK. Notably, after the FDA approval of cenegermin (Oxervate) as the first disease-modifying therapy, innovation has accelerated in this niche space, inspiring the development of second-generation formulations and alternative biologics.

Key companies advancing the pipeline include ReGenTree, LLC., Claris Biotherapeutics, Inc., among others. Several of these candidates are in Phase II/III stages, focusing on improving corneal sensitivity, epithelial closure rates, and patient-reported visual outcomes.

The report provides detailed insights into novel delivery platforms such as ophthalmic gels, eye drops, and nanocarrier systems, which enhance drug residence time and tissue penetration. Additionally, the landscape explores biomarkers for corneal nerve density and healing progression, enabling better patient stratification and monitoring of therapeutic response.

As the field moves beyond symptomatic treatments like artificial tears or tarsorrhaphy, the emphasis is now on biological repair and neuroregeneration. These next-generation therapies for neurotrophic keratitis have the potential to redefine treatment standards, offering long-term corneal preservation and significantly improved quality of life for affected individuals.

DelveInsight's comprehensive analysis highlights the emergence of disease-modifying approaches that could revolutionize NK management and bring renewed hope to patients with this sight-threatening condition.

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

Key Takeaways from the Neurotrophic Keratitis Pipeline Report
• DelveInsight's Neurotrophic Keratitis pipeline analysis depicts a strong space with 3+ active players working to develop 3+ pipeline drugs for Neurotrophic Keratitis treatment.
• The leading Neurotrophic Keratitis companies include ReGenTree, LLC., Claris Biotherapeutics, Inc., and others are evaluating their lead assets to improve the Neurotrophic Keratitis treatment landscape.
• Key Neurotrophic Keratitis pipeline therapies in various stages of development include RGN-259, CSB-001, and others.
• In July 2025, Krystal Biotech announced that the first patient has been dosed in their Phase I/II clinical trial of KB801 targeting neurotrophic keratitis

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

Neurotrophic Keratitis Overview
Neurotrophic Keratitis (NK) is a rare, degenerative eye disorder caused by damage to the trigeminal nerve, which leads to reduced or absent corneal sensation. This lack of sensation impairs the eye's natural healing response, resulting in persistent epithelial defects, corneal ulcers, and, in severe cases, perforation. Common causes include viral infections like herpes simplex or herpes zoster, ocular surgeries, diabetes, chronic use of topical medications, and neurological conditions. NK typically progresses through three stages-starting with minor surface irregularities, advancing to persistent epithelial defects, and potentially leading to stromal melting or perforation if untreated.

Because NK often presents without pain due to nerve damage, it can go unnoticed until significant damage occurs. Diagnosis is based on clinical signs and testing for corneal sensitivity. Treatment aims to protect the cornea and promote healing, starting with lubricants and moving to advanced therapies like autologous serum drops, therapeutic contact lenses, or Cenegermin (a nerve growth factor eye drop approved for NK). In severe cases, procedures like tarsorrhaphy or amniotic membrane transplantation may be necessary. Early diagnosis and intervention are critical to prevent vision loss.

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

Neurotrophic Keratitis Treatment Analysis: Drug Profile
BRM424: BRIM Biotechnology Inc.
BRM424 is a novel regenerative peptide under development by BRIM Biotechnology for the treatment of neurotrophic keratitis (NK). Derived from Pigment Epithelium-Derived Factor (PEDF), the peptide is designed to stimulate the proliferation and differentiation of corneal limbal stem cells, thereby facilitating corneal epithelial regeneration and accelerating wound healing. In preclinical models, BRM424 has demonstrated the ability to restore corneal integrity and sensory function. The FDA granted Orphan Drug Designation to BRM424 for NK in December 2022, recognizing its potential in addressing this rare condition. The therapy is currently in Phase II clinical development.

STSP-0902: Staidson (Beijing) Biopharmaceuticals Co., Ltd.
STSP-0902 is an investigational ophthalmic solution developed by Staidson (Beijing) Biopharmaceuticals for the treatment of neurotrophic keratitis. It is a recombinant human nerve growth factor (NGF) fusion protein, specifically engineered to activate the TrkA receptor pathway, which is vital for nerve repair and regeneration. Preclinical studies have shown that STSP-0902 supports corneal nerve regeneration, improves corneal structure and sensitivity, and may reduce pain-related side effects commonly associated with NGF-based therapies. The drug is currently in Phase I of clinical development for NK.

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

Neurotrophic Keratitis 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
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Scope of the Neurotrophic Keratitis Pipeline Report
• Coverage: Global
• Key Neurotrophic Keratitis Companies: ReGenTree, LLC., Claris Biotherapeutics, Inc., and others.
• Key Neurotrophic Keratitis Pipeline Therapies: RGN-259, CSB-001, and others.

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

Table of Contents
1. Introduction
2. Executive Summary
3. Neurotrophic Keratitis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Neurotrophic Keratitis Pipeline Therapeutics
6. Neurotrophic Keratitis Pipeline: Late-Stage Products (Phase III)
7. Neurotrophic Keratitis Pipeline: Mid-Stage Products (Phase II)
8. Neurotrophic Keratitis 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
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This release was published on openPR.