The FDA ( U.S. Food and Drug Administration ) has approved the first drug, Oxervate ( Cenegermin ), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea ( the clear layer that covers the colored portion of the front of the eye ).
Neurotrophic keratitis is a degenerative disease resulting from a loss of corneal sensation. The loss of corneal sensation impairs corneal health causing progressive damage to the top layer of the cornea, including corneal thinning, ulceration, and perforation in severe cases.
The prevalence of neurotrophic keratitis has been estimated to be less than five in 10,000 individuals.
The safety and efficacy of Oxervate, a topical eye drop containing Cenegermin, was studied in a total of 151 patients with neurotrophic keratitis in two, eight-week, randomized controlled multi-center, double-masked studies.
In the first study, patients were randomized into three different groups. One group received Oxervate, a second group received an eye drop with a different concentration of Cenegermin, and the third group received an eye drop without Cenegermin.
In the second study, patients were randomized into two groups. One group was treated with Oxervate eye drops and the other group was treated with an eye drop without Cenegermin.
All eye drops in both studies were given six times daily in the affected eye(s) for eight weeks.
In the first study, only patients with the disease in one eye were enrolled, while in the second study, patients with the disease in both eyes were treated in both eyes ( bilaterally ). Across both studies, complete corneal healing in eight weeks was demonstrated in 70% of patients treated with Oxervate compared to 28% of patients treated without Cenegermin.
The most common adverse reactions in patients taking Oxervate are eye pain, ocular hyperemia ( enlarged blood vessels in the white of the eyes ), eye inflammation and increased lacrimation. ( Xagena )
Source: FDA, 2018