Christoph Schäfer, CEO
CIS Pharma Website
The Cefuroxime Application System is CIS Pharma’s patented drug/device combination for preparation and injection of cefuroxime intracameral antibiotic to prevent Endophthalmitis.
Every year, 20 million cataract patients receive an intraocular lens. Endophthalmitis, also called intravitreal infection, is a rare but severe inflammatory condition of the eye, caused by microbial contamination during the surgical procedure. The incidence is reported between 0.1% and 0.05% without intracameral antibiotic prophylaxis. The treatment of Endophthalmitis is expensive and one out of two patients lose sight or the eye.
Description of Technology
The drug/device combination includes an innovative vial adaptor that prevents the 10mg/ml cefuroxime sodium solution from particulate contamination, containing several 5-micron filters. After reconstitution of the cefuroxime powder, the vial adaptor separates into two parts, immediately offering the surgeon an injection syringe with his cannula of choice. The second part of the adaptor closes the cefuroxime vial and prevents multi-use of the overfill contained.
CIS Pharma’s Cefuroxime Application System simplifies the preparation and injection of 1mg/0.1ml cefuroxime and reduces the main risk of the procedure, being dilution errors associated with non-standardized compounding. In summary, the drug/device combination improves the safety of the treatment: without the drug/device combination, the compounding is bearing the risk of contamination, dilution errors and wrong choice of diluent, as reported.
The product is approved based on a decentralized procedure in all major European markets. The injection of intracameral cefuroxime with or without the use of perioperative topical antibiotics
reduces the risk by a factor 5 to 6 for postoperative endophthalmitis following cataract surgery as shown in a number of studies across Europe and USA.
Type of Business Relationship Sought
Out license, Partnership
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