Reviewed by Stephen C. Pflugfelder, MD
The FDA approval of topical cenegermin (Oxervate, Dompé Farmaceutici SpA) for the treatment of moderate-to-severe neurotrophic keratitis (NK) last month represents a breakthrough for management of a disease that has been a frustrating problem for clinicians and devastating condition for patients.
Cenegermin, a recombinant form of human nerve growth factor (hNGF), was granted marketing authorization by the European Medicines Agency in July 2017.
“Topical cenegermin may represent a paradigm shift in the treatment of neurotrophic keratitis, a sight-threatening condition that has been treated with a variety of non-validated therapies with varying success,” said Stephen C. Pflugfelder, MD, an investigator in the cenegermin clinical trial.
“The clinical trial results for topical cenegermin showed that it was associated with statistically significant and clinically meaningful healing of neurotrophic keratitis due to different etiologies,” said Dr. Pflugfelder, professor and director of the ocular surface and the James and Margaret Elkins Chair, Department of Ophthalmology, Baylor College of Medicine, Houston.
Stephen C. Pflugfelder, MD
E: [email protected]
Dr. Pflugfelder was an investigator in the Oxervate clinical trial and is consultant for Allergan and Shire. Cenegermin will be made available by Dompé in the United States by early 2019. Details regarding patient access will be announced prior to that time.