Dompé announced that the Food and Drug Administration (FDA) has approved Oxervate (cenegermin-bkbj) ophthalmic solution for the treatment of neurotrophic keratitis in patients aged ≥2 years.
Neurotrophic keratitis is a rare and progressive ophthalmic disease that results from impaired function of corneal nerves. Prior to the approval, treatment was limited to symptomatic relief such as artificial tears, antibiotics, autologous serum-derived eye drops, tarsorrhaphy, and botulinum-induced ptosis, or surgical interventions (eg, conjuctival flap surgeries, corneal transplants).
“In the past, it has often been necessary to turn to surgical interventions; these treatments are usually only palliative in this disease, ” said Wiley Chambers, MD, an ophthalmologist in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides a novel topical treatment and a major advance that offers complete corneal healing for many of these patients.”
Oxervate,a recombinant form of human nerve growth factor (rhNGF), is structurally similar to endogenous NGF protein, which acts directly on corneal epithelial cells to stimulate growth and survival and binds to receptors on lacrimal glands to promote tear production.
The safety and efficacy of Oxervate were evaluated in 2 independent, double-masked, randomized, multicenter, controlled clinical trials involving patients with moderate to severe neurotrophic keratitis. In Study NGF0212 (N=104), 72% of patients treated with Oxervate for 8 weeks had complete corneal healing, defined as absence of staining of the corneal lesion and no persistent staining in the rest of the cornea after 8 weeks of treatment; 80% of these patients remained healed after 1 year. In Study NGF0214 (N=48), 65.2% of patients treated with Oxervate had complete corneal healing at week 8; recurrences occurred in 14% of healed patients.
With regard to safety, eye pain, ocular hyperemia, eye inflammation, and increased lacrimation were the most common adverse events seen with Oxervate.
Oxervate will be available as a 0.002% preservative-free solution in multi-dose vials in 7-count weekly cartons.
For more information call (833) 366-7387 or visit Dompe.com.