#USA #Milan #Pharmacovigilance #Dexamethasone #Levofloxacin

Landmark Study on Eye Drops for Cataract Surgery

A significant five-year pharmacovigilance study has been published, validating the safety of a fixed-dose eye drop combination intended for patients post-cataract surgery. This groundbreaking research highlights a combination of an anti-inflammatory steroid, dexamethasone, and a quinolone antibiotic, levofloxacin. Developed by NTC, this formulation aims to prevent inflammation and infections post-surgery, critical for optimizing recovery for the nearly 4 million patients treated worldwide.

Conducted by a dedicated team of Italian researchers, the study analyzed extensive public safety data from the adrreports.eu portal. This platform collects adverse drug reaction (ADR) reports registered within EudraVigilance, the European Medicines Agency’s main database. Impressively, from 2020 to 2024, only 53 ADRs were documented in 25 patients, emphasizing the safety of this treatment protocol.

Key Findings of the Study

The research presents several notable outcomes:

• - Non-serious ADRs: A staggering 74% of reported adverse reactions were classified as non-serious.
• - Low Correlation to the Drug: Over half of the reactions were deemed improbable to be linked to the drug.
• - Mild Reactions: The majority of reported events involved mild reactions within the eye or skin, which are expected outcomes from topically applied ophthalmic solutions.
• - Absence of Severe Cases: Importantly, not one case of endophthalmitis, a rare and serious infection following eye surgery, was reported throughout the study.

Dr. Giorgio Ciprandi, the senior author of this publication, expressed the significance of this study, stating, "This is the first international pharmacovigilance research specifically targeting a fixed-dose eye drop combining an antibiotic and an anti-inflammatory steroid. Its wide use coupled with a promising safety profile makes it an invaluable option in managing patients after cataract surgery."

The findings bolster the current recommendation of a brief, seven-day treatment plan. This approach enhances patient compliance while mitigating risks associated with prolonged steroid use and potential antibiotic resistance.

The Role of Pharmacovigilance

The importance of pharmacovigilance in medicine cannot be overstated. This study underscores how continuous monitoring of drugs post-market approval is vital in safeguarding patient health and aiding healthcare practitioners with up-to-date safety information collected through spontaneous reporting. NTC’s Chief Scientific Officer, Alessandro Colombo, reaffirmed this sentiment, stressing the necessity of ongoing safety evaluations to protect patients effectively.

Context of Cataract Surgery

Cataract surgery is the most performed ophthalmic procedure globally. Proper management following this procedure is essential for ensuring optimal recovery outcomes. Since the approval of this innovative eye drop combination in 2020, patients have been able to enjoy a simplified treatment regimen over just a week. This not only reduces unnecessary antibiotic exposure but also limits the risks associated with extended steroid treatments.

Due to its positive safety profile, the product has successfully undergone marketing authorization renewal by European regulatory authorities, signaling confidence in its use.

About the Study

The comprehensive study, titled "Pharmacovigilance on dexamethasone 1mg/mL + levofloxacin 5 mg/mL eye drops, solution: a five-year registry," involved expert ophthalmologists and specialists in drug safety nationwide, shedding light on best practices in post-operative care.

In conclusion, this study not only highlights the efficacy and safety of the fixed-dose eye drops post-cataract surgery but also sets a precedent for future pharmacovigilance efforts in the realm of medication safety and patient care.