Five-year Pharmacovigilance study by NTC confirms safety of fixed-dose eye drops for Post-cataract Surgery
MILAN, July 17, 2025 /PRNewswire/ -- A recently published five-year pharmacovigilance study confirms the excellent safety profile of a fixed-dose combination eye drop containing an anti-inflammatory steroid and a quinolone antibiotic, developed by NTC, indicated for the prevention and treatment of inflammation and prevention of infection following cataract surgery in adults. The study was submitted when nearly 4 million patients across about 60 countries worldwide were treated with this drug.
Conducted by Italian researchers and supported by NTC, the study analyzed public safety data registered in the adrreports.eu portal, that collects safety reports from EudraVigilance, the European Medicines Agency's official adverse drug reaction (ADR) database. The study identified only 53 ADRs occurred in 25 patients between 2020 and 2024. Key findings include:
- 74% of ADRs were non-serious.
- More than half were deemed unlikely to be related to the product.
- The most frequently reported events were mild reactions involving the eye or skin—expected outcomes for a topically administered ophthalmic solution.
- No case of endophthalmitis, a severe and rare infection that can occur following eye surgery, was reported.
"This is the first international pharmacovigilance study focused specifically on a fixed-dose eye drop combining an antibiotic and an anti-inflammatory steroid," said Dr. Giorgio Ciprandi, senior author of the publication. "Its wide usage and favorable safety profile make of it a valuable option in the modern management of post-cataract patients'."
The findings support the current recommendation of a short-term, seven-day treatment course, which improves patient adherence and limits the risk of side effects or antibiotic resistance.
The study also highlights the importance of pharmacovigilance in evaluating medicines after market approval. "This analysis confirms how continuous safety monitoring is essential to protect patients and support clinicians based on safety information collected from the spontaneous reporting," said Alessandro Colombo, CSO in NTC.
Cataract surgery remains the most common ophthalmic procedure worldwide, and post-operative management is critical to ensure optimal recovery. Since its approval in 2020, this innovative combination has provided patients with a simplified one-week treatment regimen that reduces unnecessary exposure to antibiotics and minimizes the risks associated with prolonged steroid use.
Thanks to its consistent safety profile, the product has received marketing authorization renewal from European regulatory authorities.
About the Study
The study, titled "Pharmacovigilance on dexamethasone 1mg/mL + levofloxacin 5 mg/mL eye drops, solution: a five-year registry.", was conducted by experts in ophthalmology and drug safety.
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