Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.
Drugs. 2020 Apr;80(5):489-494. doi: 10.1007/s40265-020-01289-w.
Cenegermin (Oxervate™), an ophthalmic solution containing 20 µg/mL of recombinant human nerve growth factor (rhNGF), is the first drug to be approved for the treatment of neurotrophic keratitis (NK; also referred to as neurotrophic keratopathy). In the registration trials, the majority of adults with moderate or severe NK experienced complete corneal healing after up to 8 weeks of topical cenegermin therapy. The rate of complete corneal healing was generally higher, and that of disease progression was lower, with cenegermin than with vehicle. Although the drug provided no statistically significant benefit over vehicle in terms of corneal sensitivity or visual acuity after 8 weeks of treatment, few patients with corneal healing experienced disease recurrence over 48 weeks of follow-up. Longer-term data are needed to definitively determine the efficacy of cenegermin with respect to these outcomes; further investigation into cenegermin re-treatment following disease recurrence would also be beneficial. Cenegermin had no detrimental impact on health-related quality of life (in contrast to some surgical treatments) and was generally well tolerated. Cenegermin is thus a welcomed non-surgical treatment option approved for this rare and challenging degenerative disease.
Cenegermin（Oxervate™）是一种含有 20μg/mL 重组人神经生长因子（rhNGF）的眼科溶液，是首个获批用于治疗神经营养性角膜炎（NK；也称为神经营养性角膜病变）的药物。在注册试验中，多达 8 周的局部给予 Cenegermin 治疗后，大多数中重度 NK 成人患者实现了完全角膜愈合。Cenegermin 的完全角膜愈合率通常更高，疾病进展率更低，而与载体相比。尽管在治疗 8 周后，该药在角膜敏感度或视力方面并未显示出优于载体的统计学意义上的益处，但在 48 周的随访中，少数经历角膜愈合的患者出现了疾病复发。需要更长期的数据来明确确定 Cenegermin 在这些结局方面的疗效；对疾病复发后再次使用 Cenegermin 进行进一步研究也将是有益的。Cenegermin 对健康相关生活质量没有不利影响（与某些手术治疗相反），且总体耐受性良好。因此，Cenegermin 是一种备受欢迎的获批用于这种罕见且具有挑战性的退行性疾病的非手术治疗选择。
