OBJECTIVES: Neurotrophic keratitis or keratopathy (NK) is a rare corneal disease caused by trigeminal nerve damage, which leads to poor corneal healing, that can progress to corneal melting and perforation (Dua et al., 2018) The treatment effect of recombinant human nerve growth factor (cenegermin, 20 µg/ml) eye drops in adult patients with moderate-to-severe NK, has been assessed in two randomised, double-masked, vehicle-controlled trials (NGF0212/ NCT01756456 and NGF0214/ NCT02227147). Data from these trials were used to evaluate the impact of treatment on quality of life (QoL) of patients with NK.

METHODS: Patients were treated with cenegermin or vehicle, 6 drops daily for 8 weeks. To assess QoL, EQ-5D visual analogue scale (VAS) was administered at baseline and at 8 weeks. The results of the EQ-5D VAS were assessed for each study separately. Then a meta-analysis was performed. All patients who had EQ-5D VAS assessment at baseline and 8 weeks were included in the analyses.

RESULTS: In NGF0212, mean EQ-5D VAS scores changed from 69.1 (SD=17.8, n=40) at baseline to 67.2 (SD=16.5) at 8 weeks for vehicle and from 60.0 (SD=19.5, n=41) to 65.2 (SD=21.3) for cenegermin. In NGF0214, EQ-5D VAS scores changed from 80.1 (SD=12.7, n=15) at baseline to 78.0 (SD=19.0) at week 8 for vehicle and from 78.1 (SD=18.4, n=18) to 82.1 (SD= 15.0) for cenegermin.

Although in both studies EQ-5D VAS improved for cenegermin and decreased for vehicle, results were not statistically significant on study level. Meta-analysis on LSMean difference (4.05, 95%-CI [1,28; 6,82], p=0.0042 in the fixed model showed a statistically significant improvement for cenegermin versus vehicle.

CONCLUSIONS: Despite the characteristics of NK (eg often unilateral presentation, and often with lack of symptoms) which complicates the quantifiable assessment of disease impact on patients’ QoL. These analyses showed that cenegermin can improve QoL of patients with NK.