NK is a rare and progressive eye disease, which may result in corneal scarring and vision loss. The FDA has approved Oxervate eye drops for use in adults and children two years of age and older.
FDA Center for Drug Evaluation and Research ophthalmologist Wiley Chambers said: “In the past, it has often been necessary to turn to surgical interventions; these treatments are usually only palliative in this disease. Today’s approval provides a novel topical treatment and a major advance that offers complete corneal healing for many of these patients.”
Oxervate is a topical solution administered six times per day for eight weeks for the treatment of neurotrophic keratitis.
Oxervate is composed of cenegermin-bkbj, a recombinant human nerve growth factor (rhNGF) that is structurally similar to the nerve growth factor (NGF) protein, which is made in the human body including in the ocular tissues.
The safety and efficacy of Oxervate was evaluated in two independent, double-masked, randomized, multi-center and controlled clinical trials.
Both studies assessed Oxervate monotherapy (20 mcg/mL) as compared to vehicle, a proxy for preservative-free artificial tears, among patients with moderate or severe neurotrophic keratitis.
The REPARO (NGF0212) study, which was carried out in Europe, had randomized 52 patients to each group.
Around 72% of patients in the treatment group have been completely healed after eight weeks, said the company.
The NGF0214 study was carried out in the US, and randomized 24 patients to each group. According to the firm, around 65.2% of treated patients were completely healed.
Oxervate is a topical solution administered six times per day for eight weeks for the treatment of neurotrophic keratitis.
Dompé chairman Sergio Dompé said: “Oxervate represents the first therapy from Dompé that will be available in the United States.
“We are dedicated to delivering this important treatment to people living with neurotrophic keratitis and are grateful to the patients and physicians who participated in clinical trials and enabled this advancement.”