Adjunctive Antifibrotic Therapy with Mitomycin C and 5-Fluorouracil: A Review of their use in Glaucoma Surgery and Considerations around Ophthalmic Compounding

Abstract

Background: Antifibrotics and antimetabolites, including 5-fluorouracil (5-FU) and mitomycin C (MMC), have been used for decades to improve ophthalmic surgical outcomes, most notably with glaucoma filtering procedures. Adjuvant MMC and 5-FU also enhance the efficacy of minimally invasive subconjunctival drainage implants now being used. The authors feel that a review of the usage and safety of these agents is merited, especially in light of updated and new USP guidelines for compounded and hazardous drugs.Main Body: The mode of perioperative administration of MMC during glaucoma surgery is evolving with a shift from the traditional sponge application to subconjunctival injection, allowing for a more precise dosing and controlled administration of this medication. Several studies demonstrate effective use of MMC and 5-FU, at a variety of different doses. Most of these studies use compounded MMC and 5-FU. Glaucoma surgeons must be careful in how they source MMC, however, as the U.S. Food & Drug Administration (FDA) expects physicians to use FDA-approved drug products when clinically appropriate. When a physician determines a compounded version of MMC is clinically necessary for an individual patient, the FDA closely regulates how and when drug products can be compounded and by what type of facilities. There will also be additional increased scrutiny on storage and disposal of MMC and 5-FU as new regulations are introduced.Conclusion: This review of MMC and 5-FU and their role in glaucoma surgery will address questions regarding drug safety, procurement, use, and disposal.