Purchase this article with an account.
Leyla Yavuz Saricay, Betul Bayraktutar, Jonathan Lilley, Mina Massaro-Giordano, Pedram Hamrah; Efficacy and Tolerability of Cenegermin for Stage 1 Neurotrophic Keratopathy. Invest. Ophthalmol. Vis. Sci. 2020;61(7):374.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
Topical recombinant human nerve growth factor (rhNGF, cenegermin-bkbj, Oxervate 0.002%, Dompé U.S. Inc) has been approved by FDA in all stages of neurotrophic keratopathy (NK). Only results for stage II and III NK have been reported so far. Our aim was to evaluate its efficacy and tolerability in patients with stage 1 NK in an initial case series.
Patients with stage 1 NK with diffuse corneal fluorescein staining (CFS) and decreased corneal sensation, who did not respond to conventional therapy and were treated with rhNGF were included (n=14). Demographic features, best corrected visual acuity (BCVA), CFS using Oxford scale, nerve density analyzed by in vivo confocal microscopy (HRT3/RCM) (n=5) at baseline and after treatment, and side effects of rhNGF treatment were recorded. Nerve density of patients was compared to 22 age- and sex-matched healthy reference controls.
Fourteen eyes of 11 patients were included. The mean age was 64.9±13 years in patients and 55.6±9.0 years in reference controls (p=0.07). The etiologies of NK included Sjögren's syndrome (33%), herpes simplex keratitis (13%), laser-assisted in situ keratomileusis (6%), and penetrating keratoplasty (6%), with 40% being multifactorial. Thirteen eyes were treated for 8 weeks and 1 patient for 16 weeks with rhNGF six times a day. The mean BCVA was 20/30 and the mean CFS score was 3.6±1.0 at baseline. Following treatment, mean BCVA improved to 20/25 (p=0.02) and the mean CFS score decreased to 1.1±0.8 (p<0.001). The mean total, main and branch nerve densities at baseline were 5,274.4±4,013.6mm/mm2, 3,563.3±2,513.8 and 1,711.1±1,743.3 in NK patients and 23,886.1±3,514.8, 10,798±1,877.0 and 13,088±2,723.0 in reference controls, respectively (p<0.001). Following treatment, the mean total, trunk and branch nerve densities of patients increased to 8,459.7±3,037.2 (p=0.13), 4,905.9±1,400.5 (p=0.12), and 3,553.7±1,843.7 (p=0.11), but did not reach statistical significance. Ten patients reported mild to moderate discomfort and 1 patient discontinued rhNGF temporarily, but resumed thereafter.
Topical rhNGF improved ocular surface findings and vision in stage 1 NK patients. While nerve densities increased after treatment, it was not significant in our small pilot study. Topical rhNGF seems to be an effective and well-tolerated treatment for epithelial healing in stage 1 NK, but may result in ocular discomfort while on therapy.
This is a 2020 ARVO Annual Meeting abstract.
This PDF is available to Subscribers Only