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2026 OMIG Abstract

POSTER PRESENTATION


Long-Term Evaluation of Sterility and Stability of 1% 5-Fluorouracil Eyedrops Used for Topical Therapy of Ocular Surface Squamous Neoplasia

 Pragat Jay Muthu1, Jessica Olivera1, Michael Antonietti2, Despoina Theotoka1, Gregory Gorman3,
Matthew Massey4, Darlene Miller1, Anat Galor1, and Carol L. Karp1

1Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida; 2Massachusetts Eye and Ear, Boston, Massachusetts; 3McWhorter School of Pharmacy at Samford University, Homewood, Alabama; 4Massey Drugs, Tuscumbia, Alabama

Purpose: Evaluate whether compounded topical 1% 5-fluorouracil (5-FU) for ocular surface squamous neoplasia (OSSN) remains sterile and chemically stable beyond current short beyond-use dating.

Methods: This was a laboratory/observational study split into 2 phases. First, returned patient-used bottles were cultured from cap, rim, tip, and expressed contents on chocolate agar and tryptic soy broth. Patient surveys were utilized to assess handling use. Second, compounded bottles were stored refrigerated (2-8°C) through day 180, then room temperature (20-24°C) through day 365. High performance liquid chromatography potency, pH, and appearance were assessed at 8 time points.

Results: Thirty bottles from 15 patients were cultured a mean 181.6 days after dispensing (range 18-424). No microbial growth was detected from any cap, rim, tip, or content samples, despite reported lapses in hand hygiene (5/15) and tip contact with eye/lid/lashes (5/15). Potency stayed within 97.5%-103.6% of baseline through day 365, and 90%-110% stability limits. pH remained 8.55-8.82, with no cloudiness or color change.

Conclusions: Compounded topical 5-FU eye drops showed no detectable contamination after real-world use and 1-year chemical stability. Results support study of extended single bottle use across OSSN treatment cycles to reduce waste, cost, and patient burden while maintaining safety.



Disclosure:
S
P (CLK, patents PCT/US2022/029842, 63/627,578, and 63/435,503 with the University of Miami)
C (CLK, medical advisory board for Glaukos)
Support:
NIH Center Core Grant P30EY014801; Research to Prevent Blindness (RPB) Unrestricted Award and Career Development Awards; Dr. Ronald and Alicia Lepke Grant; The Lee and Claire Hager Grant; The Grant and Diana Stanton-Thornbrough; The Robert Baer Family Grant; The Emilyn Page and Mark Feldberg Grant; The Robert Farr Family Grant; The Jose Ferreira de Melo Grant; Mr. and Mrs. Irwin Friedman Grant; The Roberto and Antonia Menendez Family Grant; The Calvin and Flavia Oak Foundation; The Dr. Tim and Cammy Ioannides Grant; The Stephen Takach Grant; The Richard and Kathy Lesser Grant; The Ragheb Family Grant; The Honorable A. Jay Cristol Grant; The Michele and Ted Kaplan Grant; The Christian Kathke Grant; The Carol Soffer Grant; The Zvi Levin Grant; and The Richard Azar Family Grant. U.S. Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Clinical Science Research and Development Service grants I01CX002015 and I01CX002633; Biomedical Laboratory Research and Development Service grant I01BX004893; Rehabilitation Research and Development Service grant I21RX003883; U.S. Department of Defense Gulf War Illness Research Program grant W81XWH-20-1-0579; U.S. Department of Defense Vision Research Program grants W81XWH-20-1-0820 and HT9425-23-1-0608; Sjögren's Foundation grant 2023-PltGr-109; and National Eye Institute, National Institutes of Health grants U01EY034686, U24EY035102, and R33EY032468


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