Last month, the FDA released their 11-day inspection of the Global Pharma facility that resulted in 11 observations by the FDA, including a “manufacturing process that lacked assurance of product sterility. Of the 68 infections identified, there have been 3 deaths, eight cases of vision loss, and four surgical eye removals reported.
As producers of eye drops, we wanted to take the time to ensure you know the rigorous precautions we take to ensure that each batch of Autologous Serum Eye Drops (ASED) are safe. Every batch of ASED undergoes a 14-day fungal and bacterial culture testing to ensure sterility prior to distribution to the patient.
SDSEB is the only eye bank in the U.S. to do this type of testing. Because of our rigorous process, we are also the only Eye Bank in the U.S. to receive our License for Production of Biologics in California.
Synthetic eye drops have been unable to mimic the effectiveness of normal tear film for severe dry eye disease patients. ASED are derived from the patient’s own blood serum and contain many of the same biochemical properties so they are able to nourish the eye like natural tears. ASED can improve the epithelial surface environment of the eye and provide the corneal surface with the chemotactic factors, nutrients, and growth factors necessary for proliferation and therapeutic effect in ocular surface disorders.