Recent Five-Year Pharmacovigilance Study Validates Eye Drops Safety Post-Cataract Surgery

A recent five-year pharmacovigilance study conducted by NTC has confirmed the impressive safety profile of a fixed-dose combination eye drop solution. This solution, which includes both an anti-inflammatory steroid and a fluoroquinolone antibiotic, is designed for preventing and treating inflammation as well as avoiding infections following cataract surgeries in adults.

The study's findings are particularly significant, given that nearly four million patients in around 60 countries have been treated with this medication. Conducted by Italian researchers with the support of NTC, the study analyzed public safety data from the adrreports.eu portal, which compiles adverse drug reaction reports collected by EudraVigilance, the European Medicines Agency’s official database for unwanted drug effects.

Between 2020 and 2024, the study found only 53 adverse drug reactions (ADRs) among 25 patients. Notably, 74% of these ADRs were classified as mild, and in more than half of the cases, it was deemed improbable that a connection existed with the product. The most frequently reported events included mild ocular or skin reactions, which are expected outcomes for a topically administered ophthalmic solution. Importantly, there were no recorded cases of endophthalmitis, a severe and rare infection that can occur after eye surgeries.

Dr. Giorgio Ciprandi, the lead author of the publication, remarked, “This represents the first international pharmacovigilance study focusing specifically on a combination of an antibiotic and an anti-inflammatory steroid in the form of fixed-dose eye drops. Its broad application and favorable safety profile position it as a valuable option in modern post-cataract patient care.”

The study supports the current guidelines advocating for a brief, seven-day treatment plan that enhances patient compliance while reducing the risks of side effects or the development of antibiotic resistance. It underlines the critical role of pharmacovigilance in assessing medications post-market approval. Alessandro Colombo, CSO at NTC, stated, “This analysis emphasizes the importance of ongoing safety monitoring to protect patients and assist clinicians relying on safety information derived from spontaneous reports.”

Cataract surgery remains the most common ophthalmic procedure globally, making postoperative care crucial for optimal recovery. Since its approval in 2020, this innovative combination has provided patients with a simplified one-week treatment regimen, minimizing unnecessary antibiotic exposure and the risks associated with prolonged steroid usage. Due to its consistent safety profile, the product has received a marketing authorization extension from European regulatory authorities.

Study Details

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. The findings not only enhance our understanding of the safety of this specific medication but also reinforce the necessity of pharmacovigilance in safeguarding patient health post-cataract surgery.