• Skip to primary navigation
  • Skip to main content
  • Skip to footer
Mitosol Logo

Mitosol®

Mitosol Has It All

  • HOME
  • CONTACT
  • ORDER
  • RESOURCES
    • Mitosol Resource Center
    • The Mitosol Kit
    • What is Mitosol?
    • Getting Started with Mitosol
  • ABOUT US

The Mitosol Kit

The Mitosol Kit

Mitosol Kit

  • Compliant with all federal and state laws; meets new and existing standards implemented by multiple societies. 
  • The only FDA approved ophthalmic formulation of MMC. 
  • Integral Closed-System Transfer Device (CSTD) .
  • No patient specific, advanced prescription required.

Free Educational Resource

USP <800> Hazardous Drugs:
Handling in Ophthalmic Healthcare Settings.

Download the Guide

The Mitosol Kit – Professionally Convenient

Mitosol delivers the first system for MMC designed for use in ophthalmic surgery.  On-demand reconstitution eliminates refrigeration and light shielding.  Shelf life of up to 24 months. Sterile transfer to the surgical field is compliant with AORN standards.  Closed system transfer and qualified disposal strictly minimizes exposure to patients, providers, and allied health personnel.


Convenience: “Shelf-Ready” Convenience for Ophthalmic MMC

Mitosol delivers a turnkey system for preparation, use, and disposal.  Reconstituted on-demand, Mitosol does not require refrigeration or light shielding.  Shelf life of up to 24 months delivers confidence in meeting your needs and the needs of your patients every time.

  • Shelf life of up to 24 months.
  • Turnkey system: Preparation, use, delivery, and disposal.
  • Room temperature storage – No refrigeration.
  • Ambient light storage.
  • No patient specific, advance prescription required.
  • Eliminates cancellations or rescheduling due to outdated or absent MMC.
  • Pre-cut sponges speeds preparation and eliminates scissor cut fragments.
  • Reduces OR, staff, and physician downtime. 
  • Eliminates rushed preparation for last-minute cases.

Containment

Mitosol delivers a containment solution crafted specifically for the unique requirements of ophthalmic surgery.  Routine atmospheric exposure of a NIOSH recognized HD is eliminated.  A patented preparation and delivery system with qualified containment and disposal strictly minimizes exposure to patients, providers and staff.

Mitosol Delivers Strictly Minimized Risk of Exposure

Mitosol is the only FDA approved USP <800> compliant ophthalmic formulation of MMC.  From transfer, to preparation, delivery and disposal, Mitosol delivers reliable, safe and compliant performance during glaucoma surgery.

Mitomycin is a NIOSH-recognized HD

  • MMC is cytotoxic, cytogenic, mutagenic, and carcinogenic.  Demonstrable hazards – contact, vapor, aerosol, etc. – exist in all forms, whether liquid, frozen, or powder.
  • Exposure hazards range from temporary rashes to lifelong complications.
  • Standards established by ASHP, NIOSH, U.S. Pharmacopeia, and others call for the use of Closed-System Transfer Devices (CSTDs) and personal protective equipment when handling HDs.

Consistency

Mitosol Consistency Graph
Kinast RM, Akula KK, DeBarber AE, Barker GT, Gardiner SK, Whitson E, Mansberger SL, The Degradation of Mitomycin C Under Various Storage Methods, J Glaucoma 2016 Jun; 25 (6): 477-81

Liquid mitomycin-c degrades immediately and continuously.  Unless reconstituted at the time of use, actual delivered potency is unknown.  Mitosol delivers.  On-demand reconstitution delivers consistent potency to every patient, every time. 

Mitosol Delivers Consistency

  • 0.1% – Hourly degradation rate of liquid MMC.
  • 25% – Potential loss of potency from compounding to BUD.
  • 100% – Certainty that Mitosol® delivers consistent potency to every patient.

Mitosol Delivers Reduced Variables and Consistent Control

Mitosol is shelf-ready and ALWAYS at time zero. Reconstituted on the sterile field at the time of use, Mitosol delivers control of potency to you and your patients.


Compliance

By design, Mitosol delivers compliance with the Drug Quality and Security Act providing confidence in your source of supply.  Mitosol is FDA approved with an ophthalmic indication.  An integral closed system transfer device prevents hazardous exposure.  Mitosol delivers your facility compliance with all laws and standards related to the acquisition and use of ophthalmic mitomycin-c.


Cost

Sticker prices may differ, but Mitosol delivers superior value.  With zero wasted product, and elimination of cancelled procedures due to expired product, Mitosol emerges as the most cost-effective system.

Mitosol Delivers Cost Effectiveness

Mitosol is only available directly from Mobius Therapeutics. Volume based discounts are readily available. Mitosol Price Enquiries.

What is the total cost of…

  • Canceled or delayed cases due to lack of MMC availability?
  • Wasted inventory due to canceled cases or product expiration?
  • Wasted surgeon, staff and OR time?
  • Compliance or safety infractions? 

WMI-002 Rev 02/2021

Footer

INDICATION

Mitosol® (mitomycin for solution) 0.2 mg/vial Kit for Ophthalmic Use is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery.

Dosage & Administration

Mitosol® is intended for topical application to the surgical site of glaucoma filtration surgery and must be reconstituted prior to application. Sponges provided within the Mitosol® kit should be fully saturated with the entire reconstituted contents in a manner prescribed in the Instructions For Use. The sponge(s) should be applied to the treatment area for two minutes. Reconstituted Mitosol® should be used within one hour of reconstitution.

US Patents #7,806,265, #8,186,511, #D685,962, #D685,963, #9,205,075, #9,539,241 and #9,649,428; other international patents issued and pending.

Product Information

Please click here for full Product Information for Mitosol®

IMPORTANT SAFETY INFORMATION
Contraindications

Mitosol® is contraindicated in patients that have demonstrated a hypersensitivity to mitomycin in the past.

Warnings & Precautions

Cell Death: Mitomycin is cytotoxic. Use of mitomycin in concentrations higher than 0.2 mg/mL or use for longer than 2 minutes may lead to unintended corneal and/or sclera damage including thinning or perforation. Direct contact with the corneal endothelium will result in cell death. Hypotony: The use of mitomycin has been associated with an increased instance of post-operative hypotony. Cataract Development: Use in phakic patients has been correlated to a higher instance of lenticular change and cataract formation. Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to use.

Adverse Events & Reactions

The most frequent adverse reactions to Mitosol® occur locally and include hypotony, hypotony maculopathy, blebitis, endophthalmitis, vascular reactions, corneal reactions, and cataract. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088.

This site is intended only for US residents.
Use of website is governed by the Terms of Use and Privacy Policy
Corporate Responsibility