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Neurotrophic keratitis: EMA validates the marketing authorisation application for cenegermin eye drops (Oxervate®) submitted by Dompé

  • Studied for the treatment of moderate and severe neurotrophic keratitis in adults, Oxervate®, if approved, would be the first biotechnological medicinal product for this indication.
  • Neurotrophic keratitis is an ocular rare disease that affects fewer than 5 in every 10,000 people1 and for which there are currently no approved medicinal products available for the direct treatment of the nerve impairment that constitutes the main cause of this condition.
  • The evaluation of the marketing authorisation application for Oxervate®, which has been designated by EMA's COMP as an orphan drug from the treatment of neurotrophic keratitis, is likely to follow an accelerated assessment, an option provided for those medicinal products able to treat severe conditions for which there are no valid treatment options.

Milano, 12th December 2016. The biopharmaceutical company Dompé announced the acceptance of the registration application submitted to the European Medicines Agency (EMA) for Oxervate® eye drops, for the treatment of moderate and severe neurotrophic keratitis in adult patients.

Acceptance by EMA constitutes the initiation of the dossier's scientific review procedure, in order to obtain authorisation to market the medicinal product, which was designated an orphan drug for the treatment of neurotrophic keratitis by EMA's committee for Orphan Medicinal Products (COMP) in 2015. Cenegermin, the product's active substance, is the recombinant version of the human nerve growth factor (NGF), discovered by Nobel Prize winner Rita Levi Montalcini. It is a protein produced naturally by the human body and that is responsible for the development, maintenance and survival of nerve cells2.

The investigational medicinal product has been studied in patients with moderate and severe neurotrophic keratitis. Neurotrophic keratitis is a rare degenerative eye disease affecting fewer than 5 in every 10,0003 people, which causes damage to the corneal epithelium and a loss of corneal sensitivity. In its more severe forms, it can cause corneal ulcers, melting and perforation, with consequences for the visual capacity of those suffering from it4. A number of different clinical conditions such as viral infections of the cornea5, eye injuries, chemical burns and lesions, corneal surgery6, or even systemic conditions such as diabetes7 can cause the disease.

Considering the severity of the condition, the lack of valid treatment options for patients and the innovative nature of the product, at this first stage EMA decided to adopt an accelerated assessment of the dossier.

“We are proud to announce such an important breakthrough in our Research & Development pathway. If it is approved, this treatment option will bring benefits to the management of patients suffering from neurotrophic keratitis, by becoming the first biotech product to be developed by Dompé. An accomplishment testament to the passion and commitment of an extraordinary team who has believed in this project since the beginning”, explains Eugenio Aringhieri, Dompé's Chief Executive Officer Dompé. “Our daily commitment has always focussed on finding innovative answers to unmet health needs: we intend to continue providing all the information required by the regulatory authorities, in order to guarantee the availability of the medicinal product as soon as possible.” .

“Being the first to have brought the nerve growth factor from discovery to a potential future therapy is a further confirmation of the research efforts conducted by us and by the pharmaceutical companies of our country. It is a major achievement that clearly demonstrates Italy’s strengths”, explains Sergio Dompé, Chairman of Dompé. “My thoughts and my thanks at this time go to the whole team of researchers, who have participated in the project at the international level according to their roles, ensuring a significant contribution to the development of this new drug, but especially to Professor Rita Levi Montalcini, whose ingenious intuition paved the way for this research. I am referring to the studies on the nerve growth factor that earned her the Nobel Prize.”

1 M. Sacchetti, and A. Lambiase, Diagnosis and management of neurotrophic keratitis. Clin Ophthalmol 8 (2014) 571-9.
2 R. Levi Montalcini, The nerve growth factor 35 years later, Science 1987
3 idem
4 idem
5 J. Gallar, T. M. Tervo, W. Neira, J. M. Holopainen, M. E. Lamberg, F. Minana, M. C. Acosta, and C. Belmonte, Selective changes in human corneal sensation associated with herpes simplex virus keratitis. Invest Ophthalmol Vis Sci 51 (2010) 4516-22; T. J. Liesegang, Corneal complications from herpes zoster ophthalmicus. Ophthalmology 92 (1985) 316-24
6 S. Bonini, P. Rama, D. Olzi, and A. Lambiase, Neurotrophic keratitis. Eye 17 (2003) 989-995.
7 R. A. Hyndiuk, E. L. Kazarian, R. O. Schultz, and S. Seideman, Neurotrophic corneal ulcers in diabetes mellitus. Arch Ophthalmol 95 (1977) 2193-6.