Five-Year Pharmacovigilance Study Validates Safety of Fixed-Dose Eye Drops for Cataract Surgery

Five-Year Pharmacovigilance Study Validates Safety of Fixed-Dose Eye Drops for Cataract Surgery



A recent five-year pharmacovigilance study conducted by NTC has confirmed the safety and effectiveness of a fixed-dose eye drop combination designed for patients undergoing cataract surgery. This groundbreaking study represents the first of its kind focusing on a combination of an anti-inflammatory steroid and a quinolone antibiotic. The research analyzed safety data from nearly four million patients treated with this medication across about sixty countries.

The study’s findings were based on safety reports collected through the adrreports.eu portal, which compiles data from the European Medicines Agency’s EudraVigilance database. Researchers found only 53 adverse drug reactions (ADRs) documented in 25 patients between 2020 and 2024, leading to significant conclusions:

1. Seventy-Four Percent of the reported adverse events were classified as mild and not serious.
2. More Than Half of these events were evaluated as unlikely to be linked to the product.
3. The most frequently reported reactions included mild ocular and skin responses, which are typical for a topical ophthalmic solution.
4. Importantly, No Cases of Endophthalmitis, a severe and rare infection that could arise after eye surgery, were reported.

Dr. Giorgio Ciprandi, the principal investigator of the study, remarked, "This is the first international pharmacovigilance study specifically assessing a fixed-dose eye drop combining an antibiotic and an anti-inflammatory steroid. Its widespread use and favorable safety profile make it a valuable option in the modern management of cataract patients."

These results support the existing recommendation for a short, seven-day treatment plan that is designed to enhance patient adherence while minimizing the risk of side effects or antibiotic resistance. The study emphasizes the crucial role of pharmacovigilance in the post-marketing evaluation of drugs, stating that continuous safety monitoring is vital to protect patients and assist healthcare providers based on safety information gathered through spontaneous reports. Alessandro Colombo, the Chief Scientific Officer at NTC, noted, "This analysis reaffirms that ongoing safety monitoring is essential to safeguard patients and support clinicians."

Cataract surgery remains the most performed ophthalmological procedure worldwide, and effective postoperative management is essential to ensure optimal recovery. Since its approval in 2020, this innovative drug combination has allowed patients to benefit from a simplified one-week treatment regimen that significantly reduces unnecessary exposure to antibiotics and minimizes the risks associated with long-term steroid usage.

Thanks to its consistent safety profile, this product has been granted renewal of its marketing authorization by 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. It reaffirms that the combination of these two medications is not only effective but also supports better outcomes for patients post-cataract surgery, highlighting the importance of ongoing surveillance in the pharmaceutical industry for ensuring patient safety.

Topics Health)

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