Abstract
Purpose :
Neurotrophic keratitis (NK) is a rare, degenerative corneal disease caused by trigeminal nerve damage, leading to loss of corneal sensitivity, corneal epithelium breakdown, and poor healing. The defining feature of NK is partial or total loss of corneal sensation. Cenegermin is a recombinant human nerve growth factor indicated for the treatment of NK. The purpose of this analysis was to compare improvements in corneal sensitivity as measured using the Cochet Bonnet esthesiometer from baseline in patients treated with cenegermin 20 µg/ml or vehicle eye drops over an 8-week time period.
Methods :
Two pivotal randomized, multicenter, double-masked, vehicle-controlled trials were conducted to assess the efficacy and safety of cenegermin 20 µg/ml eye drops in patients with neurotrophic keratitis. Both trials, one conducted in Europe (NGF0212) and one conducted in the US (NGF0214), enrolled patients 18 years of age or older with neurotrophic keratitis classified as stage 2 (persistent epithelial defect [PED]) or stage 3 (corneal ulcer) and refractory to 1 or more conventional nonsurgical treatments. The other main inclusion criteria were decreased corneal sensitivity (≤ 4 cm as measured by Cochet-Bonnet) within the corneal lesion and in at least 1 corneal quadrant outside the lesion. A pooled analysis of both trials was performed on the prespecified secondary end point of change in corneal sensitivity within the PED from baseline to weeks 4 and 8. Additional analyses of corneal quadrants are ongoing.
Results :
Mean Cochet-Bonnet measurements at baseline were 0.98 cm (standard deviation [SD], 1.3) in the cenegermin group (n=76) and 0.91 cm (SD, 1.1) in the vehicle group (n=76). By week 4, in patients with available post-baseline observations, mean improvement from baseline in Cochet-Bonnet measurements was 1.14 cm (SD, 0.20) in the cenegermin group (n=57) versus 0.64 cm (SD, 0.15) in the vehicle group (n=58). This was statistically significant (p=0.044). At week 8, these same measures were 1.46 cm (SD, 0.22) in the cenegermin group (n=57) and 0.91 cm (SD, 0.18) in the vehicle group (n=50) with a trend towards significance (p=0.053).
Conclusions :
Compared with vehicle, patients treated with cenegermin demonstrated statistically significant improvement in corneal sensitivity from baseline to week 4 within the PED, with a trend towards significance at week 8.
This is a 2020 ARVO Annual Meeting abstract.