Dompé announced the first treatment of a patient with Oxervate eye drops (cenegermin-bkbj) in the United States. Oxervate was approved by the FDA in August 2018 as the first drug specifically indicated to treat neurotrophic keratitis (NK), a rare and progressive eye disease that can lead to corneal scarring and visual loss.1=
“I am excited to be among the first physicians to treat neurotrophic keratitis patients with this new therapy,” Giacomina Massaro-Giordano, MD, of the Scheie Eye Institute at the University of Pennsylvania and an investigator in the Oxervate clinical trials, said in a company news release. “This newly approved therapy provides clinical improvements for NK patients, many of whom are at risk for losing their sight, and treatment options to help them were previously limited to symptom management.”
Patient Access to Oxervate
Prior to commercial availability, Oxervate was provided to individual patients through an Expanded Access Program with approval from the FDA. Dompé remains committed to patient access and has provided a comprehensive patient support program called Dompé Connect to Care (DC2C). DC2C will provide educational resources on NK and Oxervate for both patients and physicians. DC2C also provides financial assistance to eligible patients through the Oxervate Co-pay Card Program, and the Dompé Patient Assistance Program. More information on these programs is available by calling 1-833-DOMPE-US. Dompé is also a member of the Corporate Council of the National Organization for Rare Diseases (NORD) and supports the organization’s RareCare program for patients with rare diseases, including neurotrophic keratitis.
“We would like to thank the patients and physicians who participated in our clinical trials and the ophthalmic and rare disease communities who have contributed to making Oxervate available,” Sergio Dompé, Chairman of Dompé, said in a company news release. “At Dompé our top priority is ensuring that NK patients are able to access the clinical benefits of Oxervate. We are also committed to continuing our investments in innovation, including our programs related to nerve growth factor and in other areas of unmet medical need.”
Oxervate is now commercially available in the U.S. and can be ordered through Accredo Specialty Pharmacy by calling 1-877-831-8112.
Oxervate is the first-ever FDA-approved application of a human nerve growth factor as drug or treatment, and the first-ever topical biologic medication approved in ophthalmology. Oxervate was approved in August 2018 as an orphan drug by the FDA after being granted Breakthrough Therapy Designation, Fast Track Status, and Priority Review. Oxervate is approved in multiple jurisdictions worldwide, including those in the European Union.