In 2015, the product wasdesignated as an orphan drug in Europe for the treatment of neurotrophic keratitis, a rare eye disease that affects less than 5 out of every 10,000 people. Until now, there have been no authorised drugs for this condition.
Dompé, an Italian biopharmaceutical company, announces that the European Commission has granted a marketing authorisation for Oxervate® (cenegermin eye drops) for the treatment of moderate to severe neurotrophic keratitis. This is the first biotechnology treatment authorised for neurotrophic keratitis in adults in Europe. The product responds to the needs of patients affected by this rare and severely debilitating eye disease that can cause vision loss.
"Neurotrophic keratitis is a rare disease that is particularly debilitating, and until now, patients have had no treatment options. The European Commission adopted decision is a milestone for patients affected by this disease, for the research in this sector, and for our Company", affirms Eugenio Aringhieri, Chief Executive Officer of Dompé Pharmaceuticals. "Oxervate is our first biotech drug and its licensingis due to the hard work of a skilled and passionate team that has believed in this project from the beginning. This hasincluded the constant collaboration with an excellent medical community, contributing to the development of the product in its various phases in national and international centres. It is a long, complex but exciting journey that has not reached an end but begins with this important regulatory step. The next steps will be to make the product available in other areas outside of Europe."
Commenting on the recent marketing authorisation, Professor Harminder Singh Dua, Chair and Professor of Ophthalmology, University of Nottingham and Consultant Ophthalmologist, Nottingham University Hospitals NHS Trust said "The cause of neurotrophic keratitis is linked to damage to the trigeminal nerve - one of the nerves responsible for the anatomical and functional integrity of the eye, which can lead to the loss of corneal sensitivityIn the most severe cases, it can lead to ulcers, aseptic necrosis and corneal perforation, resulting in impaired vision of those affected. Considering the severity of the disease and the lack of viable alternatives, having a therapeutic option that can act on corneal lesions is an important development for the community of ophthalmologists and to the patients themselves".
Sergio Dompé, President of Dompé Pharmaceuticals commented that, "We have taken the first nerve growth factor, from Rita Levi Montalcini's discovery after so many years of hard work, and turned it into a therapy that is now authorised in Europe.At this time, my thoughts and gratitude go out to all of the researchers, who have participated in so many countries and in various roles in the project, making an essential contribution to the creation of this new drug, but especially to Professor Rita Levi Montalcini; this research was born out of her brilliant intuition."
Dompé is one of the leading biopharmaceutical companies in Italy. It focuses on the development of innovative therapeutic solutions for diseases with a high social impact for which therapeutic options are lacking. Based in Italy, Dompé has its headquarters in Milan. Its research efforts focus on unmet therapeutic needs such as diabetes, organ transplantation, ophthalmology and oncology. The industrial pole of L'Aquila (Abruzzo) is home to a world class biotechnology plant developing drugs for Primary Care for the markets of about 40 countries worldwide. Dompé has its offices also in Albania, France, Germany, Great Britain, Spain and United States (Boston).
This press release makes reference to certain information that may not coincide with expected future results. Dompé firmly believes in the soundness and reasonableness of the concepts expressed. However, some of the information is subject to a certain degree of interpretation in relation to its research and development activities and the necessary verifications to be performed by regulatory bodies. Therefore, as of today, Dompé cannot guarantee that the expected results will be consistent with the information provided above.