What is Mitosol?
Mitosol is a sterile, lyophilized mixture of 0.2 mg mitomycin-c and 0.4 mg mannitol. When reconstituted with 1 mL sterile water for injection, the solution contains 0.2 mg/mL mitomycin-c. 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 the safe formulation, storage, delivery, and disposal of mitomycin-c in the ophthalmic surgical setting.
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 of mitomycin-c, within a closed system. This combination of components provides 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.⁽¹⁾⁽²⁾ Additionally, the Mitosol kit is compliant with the USP <800> guidelines, as well as the Drug Quality and Security Act (DQSA).
¹ Grover DS, Flynn WJ, Bashford KP, Lewis RA, Duh Y-J, Nangia RS, Niksch B, Performance and Safety of a New Ab Interno
Gelatin Stent in Refractory Glaucoma at 12 Months, American Journal of Ophthalmology (2017), doi: 10.1016/j.ajo.2017.07.023
² Xen® is a registered trademark of Allergan PLC
WMI-033 Rev 11/2019