Currently, many eye diseases (vernal keratoconjunctivitis, dry eye syndrome, uveitis, etc.) require the use of systemic immunosuppressants such as cyclosporine. For the prevention of corneal transplant rejection, it is used in the form of a 2% single-dose eye drop, which has so far been produced by hospital pharmacies.
Unfortunately, this hospital production is very heterogeneous both in terms of formulations and quality. In order to respond to this problem and to standardise practices, the ANSM wanted this production to be industrialised 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 from the Amiens Picardie University Hospital have designed a new formulation of eye drops based on cyclosporine. This single-dose formulation is more concentrated in cyclosporine than existing products on the market and has the advantage of being free of preservatives and excipients that irritate the eye.
“The financial and human support provided by SATT Nord as part of the maturation process for this project enabled an in vivo tolerance study to be carried out in rabbits and potential licensees to be identified; the exchanges resulted in the signing of a sub-licence to exploit the technology with the company Alept. Ciclograft is a good example of a successful partnership between the public and private sectors”, says François Xavier Denimal, Doctor of Pharmacy in the industry sector and Health Business Developer at SATT Nord.
Alept, a company specialising in the development of pharmaceutical specialities and holder of various marketing authorisations, brought this new eye drop called Ciclograft to the industrial stage, then subcontracted the manufacture to Unither Pharmaceuticals (a pharmaceutical manufacturer in Amiens) and the marketing to KÔL Laboratories.
Ciclograft is a health product representing French pharmaceutical know-how, available to ophthalmologists and hospital pharmacists within the framework of the ATU nominative delivered by the ANSM on 16 December 2020. Entirely designed and manufactured in France, Ciclograft is the result of a chain of partnerships with French pharmaceutical companies. It is a French product that aspires to develop internationally.