SATT Nord and Alept have signed an exclusive sublicense agreement for the exploitation
a formulation developed by the pharmacy department of the Amiens Picardie University Hospital, which prevents prevent corneal transplant rejection.
Currently, many eye diseases (vernal keratoconjunctivitis, dry eye syndrome, uveitis, etc.) require the use of systemic immunosuppressants such as cyclosporine.
To prevent corneal transplant rejection, it is used in the form of 2% single-dose eye drops, which until now have been manufactured by hospital pharmacies.
Unfortunately, hospital production varies greatly in terms of both formulation and quality. To address this issue and standardize practices, the ANSM wanted to see this production industrialized so that controls and procedures could be put in place to ensure the quality and safety of the eye drops.
It is in this context that pharmacists at the Amiens Picardie University Hospital have developed a new formulation of ciclosporin-based eye drops. This single-dose formulation has a higher concentration of ciclosporin than existing products on the market and has the advantage of containing no preservatives or excipients that irritate the eye.
"The financial and human support provided by SATT Nord during the project's development phase enabled us to conduct an in vivo tolerance study in rabbits and identify potential licensees. negotiations were conducted with a view to signing a sublicense agreement for the technology with Alept. Ciclograft is a fine example of a successful public-private partnership," says François Xavier Denimal, Doctor of Pharmacy (industrial stream) and Health Business Developer at SATT Nord.
Alept, a company specializing in the development of pharmaceutical specialties and holder of various marketing authorizations, brought this new eye drop called "Ciclograft" to the industrial stage. It then subcontracted manufacturing to Unither Pharmaceuticals (a pharmaceutical manufacturer based in Amiens) and marketing to KÔL Laboratories.
Ciclograft is a healthcare product that showcases French pharmaceutical expertise. It is available to ophthalmologists and hospital pharmacists under the nominative temporary use authorization (ATU) issued by the ANSM on December 16, 2020.
Entirely designed and manufactured in France, Ciclograft is the result of a series of partnerships between French pharmaceutical companies. A French product with international ambitions.