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Neurotrophic keratopathy is a rare degenerative disease of the cornea characterized by reduction or loss of corneal sensitivity that can be asymptomatic or present with red-eye and, during the early stages of the disease, a minor decrease in visual acuity. It eventually leads to loss of vision.
Biomarker and diagnostic research for neurotrophic keratopathy has been reported in the published literature.
1 FDA-approved treatment is available for neurotrophic keratopathy, including CENEGERMIN-BKBJ (OXERVATE, approved 2018). An additional 6 compounds hold orphan drug designation.
Brand Name | Generic Name | Mechanism | Approved | Market Status |
|---|---|---|---|---|
Estimated prevalence: Unknown (Unknown prevalence).
13 clinical trials registered, 6 recruiting. Interventions under study include drug therapy, other interventions, procedural interventions, and biologic therapy. Pipeline includes 4 PHASE4, 1 PHASE3, 2 PHASE2. Research is sponsored by a mix of industry and academic institutions.
NCT ID | Title | Phase | Sponsor | Status |
|---|---|---|---|---|
[NCT06975748](https://clinicaltrials.gov/study/NCT06975748) |
Data assembled from 5 of 12 sources · Last updated Sep 20, 2026, 9:41 AM UTC
European rare disease database
Genetic and Rare Diseases Info Center
OXERVATE |
CENEGERMIN-BKBJ |
— |
2018 |
Available |
The following drugs have received orphan drug designation from the FDA for neurotrophic keratopathy. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor | Designated | Exclusivity End | Designation Status |
|---|---|---|---|---|---|
sodium (4Z,7Z,10R,11E,13E,15Z,17S,19Z) 10,17-Dihydroxy-docosa-4,7,11,13,15,19-hexaenoate | sodium (4Z,7Z,10R,11E,13E,15Z,17S,19Z) 10,17-Dihydroxy-docosa-4,7,11,13,15,19-hexaenoate | Anida Pharma Inc. | 2025 | — | Designated |
lacripep | lacripep | TearSolutions Inc. | 2024 | — | Designated |
allogeneic human blood serum | allogeneic human blood serum | Allovision, LLC | 2024 | — | Designated |
exosomes purified from primed human bone marrow derived mesenchymal stem cells and methacrylated hyaluronic acid | exosomes purified from primed human bone marrow derived mesenchymal stem cells and methacrylated hyaluronic acid | Pandorum Technologies, Inc. | 2023 | — | Designated |
Pigment Epithelium Derived Factor derived short peptide (Ac-Ser-Leu-Gly-Ala-Glu-Gln-Arg-Thr-Glu-Ser-Ile-Ile-His-Arg-Ala- Leu-Tyr-Tyr-Asp-Leu-Ile-Ser-Ser-Pro-Asp-Ile-His-Gly-Thr-NH2) | Pigment Epithelium Derived Factor derived short peptide (Ac-Ser-Leu-Gly-Ala-Glu-Gln-Arg-Thr-Glu-Ser-Ile-Ile-His-Arg-Ala- Leu-Tyr-Tyr-Asp-Leu-Ile-Ser-Ser-Pro-Asp-Ile-His-Gly-Thr-NH2) | BRIM Biotechnology | 2022 | — | Designated |
(1S, 4R, 5R, 7S)-3, 4-dibenzyl-2-oxo-6, 8-dioxa- 3-azabyciclo [3.2.1] octane-7-carboxylic acid-L-lysine | (1S, 4R, 5R, 7S)-3, 4-dibenzyl-2-oxo-6, 8-dioxa- 3-azabyciclo [3.2.1] octane-7-carboxylic acid-L-lysine | Recordati Rare Diseases, SARL | 2018 | — | Withdrawn |
Gene therapy approaches for neurotrophic keratopathy have been reported in the published literature.
13 trials found
A Phase II Study of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis |
PHASE2 |
Staidson (Beijing) Biopharmaceuticals Co., Ltd |
RECRUITING |
[NCT05927428](https://clinicaltrials.gov/study/NCT05927428) | Assessment of the Initial Efficacy and Safety of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis | PHASE2 | BRIM Biotechnology Inc. | RECRUITING |
[NCT06999733](https://clinicaltrials.gov/study/NCT06999733) | A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis | PHASE1 | Krystal Biotech, Inc. | RECRUITING |
[NCT05555589](https://clinicaltrials.gov/study/NCT05555589) | Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2 | PHASE3 | ReGenTree, LLC | RECRUITING |
[NCT07502378](https://clinicaltrials.gov/study/NCT07502378) | Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency | PHASE4 | University of South Florida | RECRUITING |
178 publications have been identified in PubMed for neurotrophic keratopathy. Research spans Review / Meta-Analysis (25%), Case Report / Case Series (25%), and Basic Science / Preclinical (17%).
Research Type | Count | % of Total |
|---|---|---|
Research summaries | 38 | 25% |
Patient case studies | 38 | 25% |
Laboratory research | 26 | 17% |
Clinical study results | 21 | 14% |
Disease patterns and progression | 13 | 9% |
Testing and diagnosis research | 7 | 5% |
Other research | 4 | 3% |
New treatment approaches | 3 | 2% |
Yan Y (2026). [PMID: 41617121](https://pubmed.ncbi.nlm.nih.gov/41617121/). *American journal of ophthalmology*. [Case Report / Case Series]
Bauza AM (2026). [PMID: 42004642](https://pubmed.ncbi.nlm.nih.gov/42004642/). *Clin Ophthalmol*. [Case Report / Case Series]
Luboń W (2026). [PMID: 42072832](https://pubmed.ncbi.nlm.nih.gov/42072832/). *Diagnostics (Basel)*. [Diagnostic / Biomarker]
Hou JH (2026). [PMID: 41925731](https://pubmed.ncbi.nlm.nih.gov/41925731/). *Cornea*. [Gene Therapy / Novel Therapeutics]
Fu L (2026). [PMID: 39383277](https://pubmed.ncbi.nlm.nih.gov/39383277/). *Unknown Journal*. [Basic Science / Preclinical]
Padda E (2026). [PMID: 41453402](https://pubmed.ncbi.nlm.nih.gov/41453402/). *Canadian journal of ophthalmology. Journal canadien d'ophtalmologie*. [Clinical Trial Publication]
Mackenbrock LHB (2026). [PMID: 41805863](https://pubmed.ncbi.nlm.nih.gov/41805863/). *Ophthalmologie*. [Review / Meta-Analysis]
Ferrari G (2026). [PMID: 41827440](https://pubmed.ncbi.nlm.nih.gov/41827440/). *Journal of clinical medicine*. [Basic Science / Preclinical]
Sen H (2026). [PMID: 41627595](https://pubmed.ncbi.nlm.nih.gov/41627595/). *Int Ophthalmol*. [Review / Meta-Analysis]
Gurnani B (2026). [PMID: 28613758](https://pubmed.ncbi.nlm.nih.gov/28613758/). *Unknown Journal*. [Review / Meta-Analysis]
AI-curated news mentioning neurotrophic keratopathy
Updated Aug 5, 2026
Recent research explores the potential of topical insulin therapy for treating neurotrophic keratopathy. This study highlights the therapeutic status and ongoing investigations into its efficacy.