New in corneal transplant rejection: the ANSM issues an authorisation for the first industrial eye drop based on ciclosporin 2%.

New in corneal transplant rejection: the ANSM issues an authorisation for the first industrial eye drop based on ciclosporin 2%.

SATT Nord and Alept have signed an exclusive sub-licence for the exploitation of a formulation developed by the pharmacy of the CHU AMIENS PICARDIE, allowing the prevention of corneal graft rejection

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. A French product, which aspires to develop internationally.

SATT Nord (Société d’Accélération du Transfert de Technologie) aims to accelerate the transfer of technology and knowledge from public research to companies. Supported by its shareholders, the research and higher education institutions of Hauts-de-France and Champagne-Ardenne, it detects and evaluates inventions from research laboratories. An investment fund of €58 million enables SATT Nord to protect these inventions by registering intellectual property rights and to develop them by investing in innovation projects aimed at facilitating their transfer via the creation of start-ups or by granting operating licences to companies. For more information: – @SattNord
Since 2013: 733 opportunities detected – 153 projects maturing – 40 licenses granted – 19 company creations – €32M of investments committed to maturing

ALEPT positions its developments on niche markets and/or complex dosage forms.
Thanks to the granting of this ATU, ALEPT has demonstrated that it is working together with the ANSM to provide the medical profession with a speciality that meets all international standards. This work will continue until the MA (Marketing Authorisation) is obtained.

Founded in 1993, Unither Pharmaceuticals is a global player in the manufacture of galenic forms for pharmaceutical and generic companies (notably eye drops, saline solutions and anti-asthma drugs in sterile unit doses and stick packs).
With six industrial sites and an innovation and development centre based in France, the United States, Brazil and China, the Unither Pharmaceuticals group generated sales of €330 million in 2020 and now employs over 1,500 people.
In March 2017, the Unither group was the subject of a fourth LBO by Ardian, Keensight Capital and Parquest Capital with Equistone Partners Europe and the management

KÔL Laboratories were created in 2020 by Sophie Momège, with the aim of providing solutions to unmet needs in the field of ophthalmology.
KÔL is a start-up that markets the product “Ciclograft”, which is accessible through a temporary authorization for use (ATU). The ATU is prescribed by ophthalmologists in hospitals when the drug is likely to be of benefit to the patient, and each request is validated by the ANSM.

The Amiens-Picardy University Hospital Centre is a centre of excellence in health and has four missions: care, research, teaching and management of medical demography.
It is one of the two university hospitals in Hauts-de-France and the largest employer in Picardy. A reference establishment, carrying out its activities both for the benefit of its local population basin and for the benefit of its Picardy region (transplants, oncology, conventional and outpatient surgery, level 3 maternity, emergencies, etc.), the Amiens-Picardy University Hospital is also proud to have received numerous national and international recognitions thanks to its dynamic and innovative teams.
A major player in health teaching, it actively participates in the curriculum of medical and pharmaceutical students, has 16 training centres for paramedical professions and a simulation centre of national and even international reputation, Simusanté®.
With an ambitious research and innovation programme, the Amiens-Picardy University Hospital has a dynamic investment policy to develop safe, quality care for every patient.
Fully committed to the city-hospital health plan and the “Somme Littoral Sud” hospital grouping (10 public health establishments), the Amiens-Picardie University Hospital favours territorial synergies and capitalises on the emergence of know-how. The Amiens Picardie University Hospital, Excellence on a human scale for each patient.

Key figures 2019 of the Amiens-Picardie University Hospital

800,000 visits per year, 1,664 beds and places, 6,396 staff including 832 medical staff
471,900 outpatient consultations, 33,458 surgical operations, 104
207 emergency room visits
2,375 births,16 schools and training centres