(Albany, US) On November 09, 2026, DelveInsight’s “Neurotrophic Keratitis Market Insights, Epidemiology, and Market Forecast – 2036” report provides comprehensive insights into the Neurotrophic Keratitis market and pipeline landscape across the 7MM. It covers marketed and emerging drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type, and examines the market drivers and barriers shaping the space.
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Key Takeaways from the Neurotrophic Keratitis Report
In July 2026, Krystal Biotech responded to a USPTO Office Action on a KB801 patent application, submitting clinical evidence from a patient in a discontinued study who achieved complete closure of a persistent corneal epithelial defect.
In June 2026, Lacripep (Tear Solutions) received both Orphan Drug Designation and FDA Fast Track Designation for neurotrophic keratitis. In February 2026, its Phase II study began enrolling patients with Stage 1 disease.
In September 2025, HLB Therapeutics announced the expansion of the global Phase III program for RGN-259 (ReGenTree) into Europe following progress in the US trial program. RGN-259 holds FDA Orphan Drug Designation.
The neurotrophic keratitis market across the 7MM was about USD 1 billion in 2025 and is expected to reach about USD 2 billion by 2036, a CAGR of 2.4% from 2026 to 2036.
DelveInsight estimates about 60,000 diagnosed prevalent cases in the 7MM in 2025, including about 40,000 in the US and about 3,000 in Japan.
OXERVATE (cenegermin-bkbj) is the only approved disease-specific therapy, approved in the US and EU, while Japan has no approved therapy specifically for neurotrophic keratitis.
DelveInsight’s report depicts a market that is diagnosis-limited rather than prevalence-limited, with a small pipeline focused on regenerative peptides and gene therapy.
Leading Neurotrophic Keratitis companies include Dompé Farmaceutici, ReGenTree, Tear Solutions, Claris Bio, Krystal Biotech, and others.
Promising therapies include cenegermin-bkbj (OXERVATE), RGN-259, lacripep, CSB-001 (oremepermin alfa), KB801, and others.
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Neurotrophic Keratitis Overview
Neurotrophic keratitis, also called neurotrophic keratopathy, is a rare, progressive degenerative corneal disease caused by impaired trigeminal nerve innervation, which reduces or abolishes corneal sensation. Main risk factors include herpes simplex and herpes zoster infections, trigeminal neuralgia surgery, ocular and orbital surgery, facial trauma, chemical and thermal injuries, contact lens wear, chronic topical medication use, and diabetes. Diagnosis rests on corneal sensitivity testing, fluorescein staining, Schirmer testing, slit-lamp examination, and in vivo confocal microscopy. Treatment depends on stage: lubricants, autologous serum drops, therapeutic contact lenses, and amniotic membrane transplantation, with OXERVATE as the disease-modifying benchmark, and tarsorrhaphy, conjunctival flap, corneal transplantation, or corneal neurotization in advanced or non-healing cases.
Common features include:
Reduced or absent corneal sensation
Persistent epithelial defects
Corneal scarring and neovascularization
Risk of ulceration and loss of globe integrity
Frequent delay in diagnosis due to overlap with dry eye disease
Neurotrophic Keratitis Emerging Drugs Profile
RGN-259 (Timbetasin): ReGenTree RGN-259 is a preservative-free thymosin beta 4 ophthalmic solution. In the eye, thymosin beta 4 promotes corneal epithelial cell migration, reduces inflammation and apoptosis, and accelerates repair and regeneration. It holds FDA Orphan Drug Designation, and the global Phase III program is expanding into Europe. Currently, the drug is in Phase III.
Lacripep: Tear Solutions Lacripep is a first-in-class regenerative peptide derived from the C-terminal region of lacritin, designed to promote corneal nerve regeneration, tear secretion, and epithelial restoration. It holds Orphan Drug and Fast Track designations. Currently, the drug is in a Phase II trial in Stage 1 neurotrophic keratitis.
KB801: Krystal Biotech KB801 is a gene therapy designed to provide sustained local expression of nerve growth factor in the cornea, supporting healing while potentially reducing treatment frequency and burden.
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Neurotrophic Keratitis Market Drivers and Barriers
Neurotrophic Keratitis Market Drivers
Growing at-risk population: An aging population and rising diabetes, herpes infections, ocular surgery, and contact lens use enlarge the pool of patients at risk.
Shift to disease-modifying care: The field is moving from supportive management toward therapies that promote nerve regeneration and epithelial healing.
Improving diagnosis: Greater awareness and corneal sensitivity testing support earlier recognition and referral.
Regenerative pipeline: Peptides, gene therapy, and small molecules aim for better durability and lower treatment burden.
Regulatory support: Orphan and Fast Track designations help advance candidates.
Unmet need: Dosing burden and cost with the current therapy leave room for convenient alternatives.
Geographic expansion: Phase III expansion into Europe and the absence of an approved therapy in Japan open further opportunities.
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Neurotrophic Keratitis Market Barriers
Underdiagnosis: Low awareness and symptom overlap with dry eye delay referral to corneal specialists.
Dosing burden and cost of OXERVATE: The six-times-daily regimen, high price, and prior authorization create adherence and access issues.
Reimbursement hurdles: The withdrawal of OXERVATE from the Scottish Medicines Consortium assessment shows pricing challenges even for first-in-class orphan drugs.
Small patient population: Rarity limits trial recruitment and commercial scale.
Limited pipeline: Few late-stage candidates mean growth depends on a handful of programs.
Lack of biomarkers: There are no validated markers for disease monitoring.
Established supportive and surgical care: Low-cost lubricants, serum drops, and procedures remain widely used.
Scope of the Neurotrophic Keratitis Report
Coverage: 7MM (US, EU4, UK, Japan)
Companies: As listed above
Therapies: Cenegermin-bkbj (OXERVATE), RGN-259, lacripep, CSB-001 (oremepermin alfa), KB801, and others
Study Period: 2022–2036 (Historical: 2022–2025; Forecast: 2026–2036; Base Year: 2025)
Analysis: Epidemiology segmentation, market size by therapy, drug uptake, KOL views, SWOT, attribute analysis, reimbursement, unmet needs
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Table of Contents
Introduction
Executive Summary
Neurotrophic Keratitis: Overview
Pipeline Therapeutics
Therapeutic Assessment
DelveInsight’s Analytical Perspective
Late Stage Products (Phase III): RGN-259 (ReGenTree)
Mid Stage Products (Phase II): Lacripep (Tear Solutions)
Early Stage Products (Phase I): None specified
Preclinical and Discovery Stage Products
Inactive Products
Key Companies
Key Products
Unmet Needs
Market Drivers and Barriers
Future Perspectives and Conclusion
Analyst Views
Appendix
About Us
About DelveInsight DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe.
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