A 2024 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting abstract reported a retrospective case series evaluating generic versus brand intracameral moxifloxacin in cataract surgery at a U.S. safety-net hospital. An interim analysis included 265 eyes (81.5% generic, 18.5% brand) from surgeries performed between April 2021 and April 2023. On postoperative day 1, rates were similar for corneal edema (63.9% generic vs 65.3% brand), best corrected visual acuity (BCVA) ≥20/40 (60.9% vs 62.5%), and intraocular pressure (IOP) >21 mmHg (20.7% vs 22.2%); at postoperative month 1, persistent inflammation occurred in 11.2% vs 21.4% and corneal edema in 0.6% vs 11.1%, respectively. No cases of toxic anterior segment syndrome (TASS) or endophthalmitis were observed in either group in this interim analysis, with authors noting the limited sample size. Of note, these findings reflect intraoperative intracameral use and may not be generalizable to routine postoperative topical moxifloxacin eye drops. [1]
A 2020 FDA Alert reported TASS cases associated with intraocular administration of moxifloxacin, noting that topical products such as Vigamox (moxifloxacin ophthalmic solution) 0.5% and Moxeza (moxifloxacin ophthalmic solution) 0.5% are FDA-approved only for topical use and are not approved for intraocular injection. Review of the FDA Adverse Event Reporting System (FAERS) through December 19, 2019 identified 29 TASS cases linked to intraocular drugs containing moxifloxacin, including 16 compounded from bulk drug substance, 10 repackaged Moxeza, 2 Vigamox, and 1 Moxeza, with most following cataract surgery. Of these, five cases reported 0.5% moxifloxacin at a volume of 0.5 mL and one case reported 0.1% moxifloxacin at 0.1 mL, while 23 did not report volume. In one facility, 10 cases developed within one week, ceased after discontinuation, and recurred after reintroduction of compounded moxifloxacin. The FDA highlights that risk relates to concentration, volume, and inactive ingredients, noting that Moxeza contains xanthan gum, which has been linked to TASS. Published studies have described intraocular use at ≤0.3 mL with concentrations ≤0.5% as unlikely to cause significant adverse events. Therefore, clinicians are cautioned to carefully consider the formulation before any intraocular administration. Importantly, this communication does not evaluate generic topical moxifloxacin formulations. [2]
A review of more recent publicly available FAERS data identified 41 reports of moxifloxacin-associated TASS from 2012 to 2025; importantly, these reports may represent a mix of brand and generic products and different formulations or routes of use, as product naming and formulation details in FAERS are variable and not standardized. Given the nature of FAERS, which relies on voluntary reporting and may include incomplete or unverified information, these data should be interpreted cautiously and cannot be used to determine incidence or establish causality. [3]
A 2021 literature review described multiple case reports in which intracameral Vigamox 0.1 mL of 5 mg/mL (0.5%) was associated with findings such as anterior chamber inflammation, pigment dispersion, pupillary abnormalities, and elevated IOP, with onset reported at ~2 to 6 weeks after cataract, glaucoma, or vitrectomy surgery. In contrast, large series using diluted or lower-dose intracameral moxifloxacin (including 50 to 500 mcg/mL and volumes up to 0.3 to 0.4 mL) noted no cases of TASS, while in vitro studies showed cell toxicity at concentrations >500 mcg/mL. The authors emphasize that, regardless of antibiotic choice, the drug name, preservative status, concentration, and planned injection volume should be verified at each step of preparation by involved personnel, with the surgeon serving as the final check before intraocular administration. If an error occurs and results in anterior segment toxicity, prompt control of inflammation and intraocular pressure is indicated. [4]
An additional review describes 2 cases of TASS, later linked to a systemwide outbreak from reusable cannulas that resolved after switching to disposable cannulas, highlighting instrument-related contamination as a potential source of TASS rather than moxifloxacin itself. [5]
Lastly, a 2006 prospective safety study evaluated prophylactic intracameral moxifloxacin 0.5% (Vigamox) in 65 eyes undergoing cataract surgery, with 0.1 mL injected at the end of phacoemulsification. At 1 month, all eyes achieved BCVA ≥20/30, showed only trace anterior chamber cells/flare on day 1, and had no significant change in endothelial cell density (mean difference [MD] −70 cells/mm²; p= 0.737) or corneal thickness (+17.8 µm; p> 0.65). The authors concluded that intracameral Vigamox appeared nontoxic in terms of visual rehabilitation, anterior chamber reaction, pachymetry, and corneal endothelial cell density, although TASS was not explicitly assessed or reported as an outcome. [6]