Medication Monitor



Generic Name (Trade Name—Company)
Notes
August 28, 2018

Cenegermin

(Oxervate—DompĂ© farmaceutici SpA)
FDA approves first drug for neurotrophic keratitis, a rare eye disease

FDA has approved cenegermin, the first drug for treatment of neurotrophic keratitis, a rare disease affecting the cornea.

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. Prevalence of neurotrophic keratitis has been estimated to be fewer than 5 in 10,000 individuals.

Safety and efficacy were studied in 151 patients with neurotrophic keratitis in two randomized, controlled, multicenter, double-masked studies lasting 2 weeks.

Across both studies, complete corneal healing in 8 weeks was demonstrated in 70% of patients treated with cenegermin compared with 28% of patients treated without cenegermin.

The most common adverse reactions in patients taking cenegermin are eye pain, ocular hyperemia (enlarged blood vessels in the white of the eyes), eye inflammation, and increased lacrimation (watery eyes).