Privately-held Italian company Dompé has had its marketing authorization application of cenegermin eye drops for the treatment of moderate to severe neurotrophic keratitis approved by the European Commission (EC).
It is the first biologic approved in the European Union for this condition, a rare and severely debilitating eye disease that can cause vision loss. Until now, there have been no approved drugs for patients affected.
“The next steps will definitely be to make the product available in other areas outside of Europe and in other future indications”
The development of cenegermin stems from the studies of Nobel laureate Rita Levi Montalcini, who discovered the nerve growth factor (NGF). This led to a collaboration between Dompé and centers of excellence in ophthalmology.
Eugenio Aringhieri, chief executive of Dompé Pharmaceuticals, said: “Neurotrophic keratitis is a rare disease that is particularly debilitating, and until now, has been an unresolved health concern for patients. The authorization obtained by the EC is a milestone for the patients affected by this disease, for the research in this sector and for our company.
“It is our first biotech drug that was obtained thanks to the work of a skilled and passionate team that has believed in this project from the beginning, and thanks to the constant collaboration with an excellent medical community, which has contributed to the development of the product in its various phases in national and international centers.
“It is a long, complex yet exciting journey that never ends but begins with this important regulatory step. The next steps will definitely be to make the product available in other areas outside of Europe and in other future indications.”
Cenegermin is the name of the primary active ingredient of the drug, and it is the recombinant version of the human NGF, developed and prepared through a biotechnological production process unique to Dompé. It is a protein that is almost identical to the one the human body produces naturally, which is involved in the development, maintenance and survival of nerve cells.
Administered as eye drops in patients with moderate to severe neurotrophic keratitis, this solution can help restore the normal healing processes of the eye and repair corneal damage.
The process of registering the drug is underway in the USA too, where cenegermin is still an investigational product, and where Dompé has started the submission to the Food and Drug Administration of the first part of the Biologics License Application. In Japan dialogue has begun with the Pharmaceuticals and Medical Devices Agency to define a similar development plan.