#USA #Pharmacovigilance #Milano #NTC #Cataract Eye Drops

NTC's Five-Year Study on Eye Drops for Cataract Surgery

A comprehensive five-year pharmacovigilance study published by NTC has confirmed the exceptional safety profile of a fixed-dose combination eye drop, designed for use after cataract surgery. This pioneering study has brought to light crucial data regarding the drug’s safety, with almost 4 million patients in over 60 countries having received treatment with this formulation. The findings present a significant advancement in post-operative care for cataract surgery patients.

The study, spearheaded by Italian researchers with the support of NTC, closely analyzed public safety data reported through the adrreports.eu portal, which aggregates reports from EudraVigilance, the European Medicines Agency's official adverse drug reaction database. The five-year investigation identified merely 53 adverse drug reactions (ADRs) among 25 patients between 2020 and 2024. Key findings included that 74% of these ADRs were not severe and that more than half were deemed unlikely to be associated with the eye drop product itself.

Frequent reported events were primarily minor reactions affecting the eye or skin, typical for any topical ophthalmic solution. Impressively, there were no reported cases of endophthalmitis, a serious and rare infection that can occur following eye surgery.

Dr. Giorgio Ciprandi, the lead author of the study, emphasized its groundbreaking nature, stating,