Abstract
Purpose :
To evaluate the short- and medium-term effects of topical cenegermin on corneal physiology in neurotrophic keratopathy (NK) patients.
Methods :
In this prospective cohort study (NCT04627571), patients ≥18 years old diagnosed with NK refractory to treatments for ≥2 weeks were recruited. Patients who have used cenegermin or autologous serum eyedrops 8 weeks prior to study recruitment were excluded. Patients with stromal ulceration ≥75% of total corneal thickness, impending perforation, corneal surgery ≤3 months, and presence of active microbial infection were also excluded. Evaluations include Ocular Surface Disease Index (OSDI) questionnaire, tear film osmolarity (TearLab, San Diego, CA) anterior segment OCT (ASOCT, Optovue, CA), Cochet-Bonnet esthesiometry (Luneau, France); Schirmer testing without anaesthesia; and in vivo confocal microscopy (HRT3 RCM, Heidelberg, Germany). Evaluations were performed at baseline, 4, 6, and 8 weeks, and 3, 6, 9 and 12 months post-cenegermin initiation (Oxervate, Dompè US). Statistical analyses were performed with paired-t tests.
Results :
In this interim analysis, corneal sensation and ASOCT data on 7 eyes (6 patients) were reported. At baseline, best corrected visual acuity (BCVA) was 0.83±0.69 logMAR, and 2 eyes had epithelial defects. Mean central corneal sensation (CCS) improved from 7.6±13.2 at baseline to 22.5±19.2mm by 4 weeks (P=0.01), whereas peripherally (PCS) this improved from 19.8±20.8 to 25.2±10.6mm by 6 weeks (P=0.002). However, CCS and PCS in subsequent visits up to 6 months were not significantly different from baseline values. Corneal epithelial thickness (CET) on ASOCT at the central 3mm zone did not change significantly up to 6 months (baseline v 6months, 46.7±3.4 v 48.2±3.1µm, P=0.24). However, CET at the thinnest point increased significantly by 8 weeks (31.4±8.6 to 36.3±4.2µm, p=0.04), and paracentral CET at the 3-5mm zone also significantly increased from baseline values (48.1±5.6µm) by 6 weeks after treatment initiation (6-weeks: 51.2±5.0µm, p=0.04; 8-weeks: 50.2±3.8µm, p=0.02; 3-months: 52.1±5.9µm, p<0.001).
Conclusions :
Cenegermin induced early improvements in corneal sensation, but these changes were not sustained. Corneal epithelial thickness showed a dynamic and region-specific response, warranting further study for long term stability of these changes.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.