Active ingredient: cenegermin-bkbj
Disease: neurotrophic keratitis
Peak sales estimate: N/A
Approved: Aug. 22
The scoop: With its FDA approval, the eye drop Oxervate from Italian drugmaker Dompé became the first treatment approved for NK, a degenerative disease that triggers a loss of corneal sensation. The condition affects fewer than 65,000 people in the U.S. each year but can result in blindness if untreated.
Oxervate is a recombinant human nerve growth factor (NGF) that resembles the human body’s natural NGF and works on corneal epithelial cells to stimulate their recovery. As an eye drop, Oxervate is the first application of a human NGF as a drug and the first topical biologic approved in ophthalmology. Before the orphan drug was approved, available treatments were either palliative or, in the case of surgeries, invasive. It will be launched in 2019. — Eric Palmer