What is Mitosol?
Mitosol® a sterile lyophilized mixture of 0.2 mg mitomycin and 0.4 mg mannitol; when reconstituted with Sterile Water for Injection, the solution contains 0.2 mg/mL mitomycin. It provides a solution for topical application in glaucoma filtration surgery.
Mitosol is the only FDA approved formulation of mitomycin-c bearing an ophthalmic indication. The kit was developed with the goal of solving the problems associated with formulation, transporting, and applying mitomycin-c in the ophthalmic surgical setting.
To provide a long shelf life, the Mitosol kit prepares a single ophthalmic dose at the time of use. This ensures consistent potency to every patient, every time. Other components within the kit are provided to allow for safe and sterile use mitomycin-c, within in a closed system. The combination of components provides for a consistent concentration, safe handling, and unmatched convenience.
Mitosol has been specified by name as a companion drug in pivotal MIGS clinical trials, to include the XEN Gel Stent. Additionally, the Mitosol kit is compliant with the USP <800> guidelines, as well as the Drug Quality and Security Act (DQSA).
WMI-033 Rev 01/2018