• By Kanaga Rajan
    FDA
    Cornea/External Disease

    Following a priority review, the FDA has cleared cenergermin (Oxervate), a first-in-class treatment for moderate or severe neurotrophic keratitis.

    The novel eye drop is made by Italian-based Dompé Pharmaceuticals and is the first drug to contain recombinant human nerve growth factor. In patients with neurotrophic keratitis, it supports corneal healing and repair by promoting corneal epithelial cell growth and survival. Preclinical studies suggest that the drug also induces corneal innervation and increases tear production.

    “By directly promoting corneal healing, Oxervate has the potential to change the way neurotrophic keratitis is treated, and may eventually result in a new standard of care for patients with this rare condition,” stated Reza Dana, MD, professor of ophthalmology at Harvard Medical School and Dompé medical advisor.

    The FDA’s decision follows positive results from 2 randomized, controlled, multi-center, double-masked studies that enrolled 151 patients with the rare disease. After receiving cenergermin 6 times a day for 8 weeks, researchers observed complete corneal healing in 70% of patients, compared with 28% in the control group. Nearly 80% of patients who were healed during the 8-week regimen remained free of the disease at 1 year. Common adverse events included eye pain and inflammation, ocular hyperemia and increased lacrimation.

    Oxervate has been approved for use in the EU since 2017, and had previously received orphan drug and breakthrough therapy designations as well as fast track status by the FDA. The drug is expected to hit U.S. markets in early 2019.