LISBON, Portugal — Following approval by the European Medicines Agency in June, nerve growth factor eye drops will be available soon on the European market as a breakthrough treatment for neurotrophic keratitis and related conditions.
At the EuCornea meeting, Paolo Rama, MD, a pioneer in the use of nerve growth factor (NGF) for the treatment of corneal ulcers, said he was “immensely satisfied” with this achievement. A breakthrough molecule, which he was able to administer for compassionate use in a limited number of cases, will finally be available for widespread use.
“It has been a long story,” Rama said. In 1996, Rama and colleagues obtained the NGF from the laboratory of Rita Levi-Montalcini, who with her colleague Stanley Cohen was awarded Nobel Prize in Physiology or Medicine for discovery of NGF. Rama used the treatment in a 7-year-old girl with a deep stromal ulceration secondary to congenital trigeminal nerve agenesis.
“The ulcer closed at day 20, transparency gradually improved, and after a few months she had a perfectly transparent cornea with excellent vision, which remained stable without further treatment,” Rama said.
After this first case, Rama treated more than 100 eyes with neurotrophic ulcers under compassionate use regulations, and healing occurred in 100% of the cases.
In January 2011, Dompé acquired the worldwide rights for the development and commercialization of genetically engineered NGF (rhNGF). The first safety study was performed in 2014. Two multicenter phase 1 and 2 studies followed: one in Europe and one in the U.S. After completion of the studies in 2015, Dompé submitted a marketing authorization application to the EMA.
The drug, with the brand name Oxervate (cenegermin), is expected to be commercialized in most European countries by the end of the year. – by Michela Cimberle
Rama P. Neurotrophic keratopathy. Medical management. Presented at EuCornea; Oct. 6-7, 2017; Lisbon.
Disclosure: Rama reports he receives consultant fees and research support from Dompé.