JAN 28, 2020
This study assessed the efficacy of recombinant human nerve growth factor therapy cenegermin (Oxervate) for neurotrophic keratopathy.
The NGF0214 study was a multicenter, randomized, double-masked, vehicle-controlled clinical trial. Researchers randomized 48 patients from 11 U.S. sites to either 20 μg/ml cenegermin or vehicle eye drops. Patients received 6 drops each day for 8 weeks and were followed for 24 weeks.
Cenegermin treatment led to higher rates of corneal healing than vehicle in cases of neurotrophic keratopathy associated with nonhealing corneal defects. The authors note that the conservative measure of corneal healing showed significance as early as week 4, and by week 8, 65% of the cenegermin and 17% of the control groups achieved 0 mm of lesion staining with no other residual staining. Reflex tearing (which may reflect corneal sensitivity or nerve function not detectable by Cochet-Bonnet esthesiometer) exhibited trends favoring cenegermin treatment, but did not reach significance. Adverse events with treatment were generally local, mild and transient.
Neither the phase 2 REPARO trial nor the current NGF0214 study showed statistically significant improvements in visual acuity measures. It is difficult to form conclusions on the relative efficacy of cenegermin treatment on cases of neurotrophic keratopathy from other etiologies not studied here.
Various conditions (e.g., ocular herpetic infection, ocular or neurologic surgery, trauma, diabetes and dry eye disease) are associated with neurotrophic keratopathy. Cenegermin treatment showed higher rates of corneal healing, which may benefit the underlying cause of these conditions. This treatment will provide physicians with another tool in their armamentarium besides bandage contact lenses tarsorrhaphy, amniotic membrane transplantation and conjunctival flap.