Negotiations with collection centres in North Rhine-Westphalia and Saarland are well advanced, the necessary agreements are in the final vote. Thus, the FBM PHAMRA can immediately leave their first footprint on the map with respect to the procurement of autologous blood and blood components for the production of autologous serum eye drops (ASAT).
Further talks with one of the leading eye clinics in Germany substantiate the medical-scientific approach of ASAT. The responsible senior physician and head of the study centre of the Ophthalmic Clinic is fully convinced of the project and looks forward to its implementation as soon as the authority has granted the manufacturing authorisation.
Already done discussions with the authorities demonstrate the general feasibility. Development and validation concepts being necessary for extending the manufacturing authorisation are already coordinated with the authorities. At present, FBM-PHARMA is working hard on the implementation of those concepts. Process development is already almost completed and the necessary validation plans have been submitted to the competent authority for approval.
Clinicians and patients have long called for ensuring patient treatment with autologous serum eye drops because the ASAT for serious diseases is the only effective treatment option. Therefore, the ASAT are also recommended in the German therapeutic guidelines. Non-commercial professional bodies, such as from DRK e.V. (“haemotherapy” 2015), call for the closing of the supply gap for outpatients by a standardized production and a Germany-wide distribution of autologous serum eye drops.