ArticleOphthalmology and therapy2025
Cenegermin for the Treatment of Moderate or Severe Neurotrophic Keratopathy: Results from a Prospective, Phase IV, Open-Label Study in China.
Article in Ophthalmology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- Impact of an Ophthalmic Cooling Device on Corneal Immune and Sensory Nerve Features in Chronic Ocular Surface Pain: A Prospective, Feasibility Study.Ophthalmology and therapy · 2026Article
- Blood Derivatives in the Therapy of Ocular Surface Diseases.International journal of molecular sciences · 2025Review
- Therapeutic efficacy of cenegermin in the management of neurotrophic keratitis: a systematic review and meta-analysis of randomized controlled trials.Therapeutic advances in ophthalmologyArticle
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionNeurotrophic keratopathy (NK) is a rare degenerative disease that can lead to epithelial breakdown, corneal ulceration, and potentially perforation and vision loss. Cenegermin is a recombinant human nerve growth factor approved for stage 2/3 NK, though data on its efficacy outside of United States/European populations are limited.
methodsThis prospective, phase IV, open-label, multicenter study investigated the efficacy, safety, and pharmacokinetics (PK) of cenegermin eye drops in Chinese patients with stage 2/3 NK in a routine clinical setting (CTR20220066). Patients received cenegermin eye drops (20 mcg/mL; 6 times/day at 2-hour intervals) for 8 weeks with follow-up to week 56. The primary endpoint was corneal healing at week 8 per investigator assessment. Additional endpoints included lesion worsening, corneal healing through week 56, safety, and PK.
resultsOf the 28 patients receiving cenegermin, 22/26 (84.6%, 95% confidence interval 65.1-95.6%; 2 missing) achieved corneal healing at week 8; 3/22 (13.6%) reported recurrence during 48-week follow-up but 20/22 (90.9%) were healed at week 56; and 2/28 (7.1%) experienced lesion worsening during 8-week treatment. In addition, 25/28 (89.3%) experienced ≥ 1 treatment-emergent adverse event (TEAE); for the majority (23/28, 82.2%) of these patients, TEAEs were mild/moderate. None of the serious TEAEs reported by 10 (35.7%) patients were assessed as related to cenegermin or led to treatment discontinuation. Eye pain was the most common cenegermin-related TEAE (5/28, 17.9%), primarily limited to the treatment period.
conclusionsThese findings demonstrate that cenegermin eye drops are an effective, generally well-tolerated treatment in Chinese patients with stage 2/3 NK, supporting their use in this patient population.
trial registrationCTR20220066.
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