Nathalie Dompé honoured with the special award for Societal Impact  

Dr. Giacomina Massaro-Giordano, ophthalmologist: “The development of the first medicine based on nerve growth factor, it’s a great scientific and social result for Dompé and  Italy as a whole”

Newswise — October 13th, Washington, D.C – Sbarro Health Research Organization, on the occasion of the medical conference “The impact of environment and healthy lifestyles in human health,” honoured Nathalie Dompé, CEO Dompé Holdings, with a special Award for Societal Impact in Business & Biotechnology, for her work and effort in promoting social responsibility.

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. Its research efforts focus on unmet therapeutic needs such as diabetes, organ transplantation, ophthalmology and oncology. The industrial site of L’Aquila (Abruzzo) is home to a world class biotechnology plant which develops and produces Oxervate, an innovative drug for the treatment of neurotrophic keratitis, a very rare disease of the eye. The drug -  available for patients in Europe and, starting from January, also in US, having received FDA approval last August - is composed of NGF nerve growth factor, a molecule discovered by the Nobel-Price candidate Rita Levi Montalcini and Stanley Cohen, but its potential was not realized in ophthalmology until Dompé’s research and development center in L’Aquila, Italy, created a recombinant version of human NGF through a unique development process. This is the first ever application of a human NGF as drug or treatment.

“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 sensitivity”, says  Ophthalmologist Giacomina Massaro-Giordano. “Considering the severity of the disease and the lack of viable alternatives, having an innovative therapeutic option that can act on corneal lesions is of great importance to the community of ophthalmologists and to the patients themselves.” Dr. Massaro-Giordano was the principle investigator for the study at the University of Pennsylvania, Scheie Eye Institute. This site was instrumental in enrolling the most patients in the U.S. to demonstrate Oxervate’s efficacy in treating NK, and in enrolling a significant number of patients from a separate trial, which helped establish the safety of the product. These achievements were essential for the FDA approval of Oxervate.

The medical conference “The impact of environment and healthy lifestyles in human health” has been promoted by the Sbarro Health Research Organization (SHRO), in collaboration with Temple University’s College of Science and Technology, the National Italian American Foundation (NIAF), and the Giovan Giacomo Giordano Foundation.

Oxervate data

The efficacy and safety of Oxervate was established in two double-masked, randomized, multi-center, controlled clinical trials, REPARO (NGF0212), which was conducted in Europe, and Study NGF0214, which was conducted in the US. Both trials studied Oxervate monotherapy (20 mcg/mL) as compared to vehicle, a proxy for unpreserved artificial tears, among patients with moderate or severe neurotrophic keratitis. After eight weeks of treatment, patients exposed to Oxervate were more likely to experience complete corneal healing relative to vehicle. In REPARO, more than 72 percent of patients were completely healed after the eight week regimen.  In Study NGF0214, 65.2 percent of patients were completely healed. In REPARO, the study with the longer follow-up, approximately 80 percent of patients who resolved during the eight week treatment period were recurrence-free after one year.

Oxervate was well tolerated in clinical trials. Eye pain, which can be associated with regaining sensation that has been lost due to the disease, was the most frequent adverse reaction observed with Oxervate, being reported in approximately 16 percent of patients. Other adverse events reported in more than 5 percent of patients included swelling (inflammation) of the eye, increase of tears (increased lacrimation) and excess blood in the white of the eyes (ocular hyperemia). Findings from the REPARO trial program were also published in the March 2018 edition of Ophthamology, the journal of the American Academy of Ophthalmology.

About Dompé

Dompé is an Italian bio-pharmaceutical company that focuses on innovation, where a long tradition in the field of personal wellness goes hand-in-hand with a commitment to research and development to meet hitherto unsatisfied therapeutic needs. Established in 1940 in Milan, Dompé has an industrial and biotech research hub in L’Aquila, in addition to branches in Europe (Barcelona, Berlin, Paris and Tirana). The US headquarters of Dompé are based in Boston (R&D) and in the San Francisco Bay Area (Commercial Operations).The company has approximately 700 employees and revenue of more than $300 million.