ArticleClinical and translational science2025
Pharmacovigilance on Dexamethasone 1 mg/mL + Levofloxacin 5 mg/mL Eye Drops, Solution: A Five-Year Registry.
Article in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Pharmacovigilance on Dexamethasone 1 mg/mL + Levofloxacin 5 mg/mL Eye Drops, Solution: A Five-Year Registry.Clinical and translational science · 2025Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Cataract surgery is a common procedure requiring post-surgical pharmacological treatment to dampen inflammation and prevent infections. In 2020, a fixed eye drops combination of dexamethasone 1 mg/mL + levofloxacin 5 mg/mL for prevention and treatment of inflammation, and prevention of infection associated with cataract surgery in adults was approved. This innovative combination ensures the control of inflammation and prevents infection in a one-week course, preventing antibiotic resistance and minimizing steroid adverse events. This study aimed to collect information on reported suspected Adverse Drug Reactions (ADRs) of this product and analyze their characteristics in various System Organ Classifications. Using the European database of suspect ADRs as an access tool, we extracted line listings of reported ADRs that occurred using levofloxacin/dexamethasone from 2020 to 2024. The product has been approved in almost sixty countries worldwide, and approximately 4 million patients have been treated. A total of 53 ADRs concerning 25 patients were retrieved: 39 ADRs were not serious, while 14 ADRs were serious; 27 ADRs (51%) were evaluated as unlikely related to the drug. Eye and skin were the most common systems involved. Moreover, 15 special situations have been registered, mostly off-label use (10; 67%). Interestingly, levofloxacin/dexamethasone was not associated with confirmed endophthalmitis occurrence, one of the most serious ophthalmic emergencies. Based on data collected, no relevant safety issues have been identified that would alter the product's safety and efficacy profile. A large proportion of these ADRs were non-serious and unlikely to be related to the product or special situations.
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Registered trials
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