FDA Approves New Option For Rare Eye Disease

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

The safety of Oxervate (cenegermin), a topical eye drop, was examined in a study of 151 patients with neurotrophic keratitis in two 8-week randomized controlled multi-center, double-masked studies. Eye drops were administered 6 times a day to the affected eye in both studies.

Overall, complete corneal healing in 8 weeks was observed in 70% of patients treated with Oxervate compared to 28% of patients treated without cenegermin in both studies.

The most common adverse reactions associated with Oxervate were eye pain, ocular hyperemia, eye inflammation, and increased lacrimation.

—Michael Potts

Reference:

FDA. FDA approves first drug for neurotrophic keratitis, a rare eye disease [press release]. August 22, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM618047.htm?utm_campaign=08222018_PR_FDA%20approves%20first%20drug%20for%20neurotrophic%20keratitis%2C%20a%20rare%20eye%20disease&utm_medium=email&utm_source=Eloqua.