Oxervate Approved to Treat Neurotrophic Keratitis
August 22, 2018 – The U.S. FDA has approved Oxervate™ (cenergermin-bkbj ophthalmic solution), manufactured by Dompé Farmaceutici SpA, to treat a rare degenerative corneal disease known as neurotrophic keratitis. Oxervate is the first drug approved by the FDA to treat the disease. It is also the first human nerve growth factor (hNGF) product to receive FDA approval as a drug or treatment, and the first topical biologic medication approved for use in ophthalmology.
Neurotrophic keratitis affects approximately one in 2,000 individuals, and leads to loss of sensation in the cornea caused by impairment of the trigeminal nerve. The cornea, which is the transparent, outermost layer of the eye, helps to focus vision and maintain proper fluid balance in the eye. When the trigeminal nerve ceases to function properly, corneal tissue becomes compromised. The cornea then grows increasingly prone to thinning, ulceration, poor healing, melting, and perforation. Management of the disease is often challenging, with many patients requiring surgical intervention that offers only a palliative solution.
Cenergermin-bkbj, the active ingredient in Oxervate, is a recombinant human nerve growth factor that helps to support proper corneal innervation (nerve supply) and integrity. In clinical trials, 72% of patients who received Oxervate experienced complete corneal healing versus 30% of patients who received a placebo. Approximately 80% of patients who experienced success with Oxervate remained healed after a full year. A full course of treatment lasts eight weeks, with a recommended dosing of one drop administered in the affected eye six times per day, at two-hour intervals.
Dompé plans to launch Oxervate in the U.S. in early 2019.