Milan,, July 17, 2025 / Prnewswire / – A recently published five -year pharmacovigilance study confirms the excellent safety profile of a dose of the fixed dose eye containing a anti-inflammatory steroid and a Antibiotic QuinoloneDeveloped by NTC, indicated for the prevention and treatment of inflammation and prevention of infection after cataract surgery in adults. The study was subjected when almost 4 million patients through 60 countries of the world were treated with this medication.
Directed by Italian researchers supported by the NTC, the study analyzed the public security data recorded in the adrreports.eu portal, which collects security reports from EudravigilanceThe official database of undesirable drug reaction (ADR) of the European Medicines Agency. The study only identified 53 Adrs occurred in 25 patients Between 2020 and 2024. The main results include:
- 74% of ADRs were no series.
- More than half have been deemed unlikely to be linked to the product.
- The most frequently reported events were light reactions involving the eye or skin – the results provided for an ophthalmic solution administered by topical.
- No case of endophthalmicismA severe and rare infection that can occur after eye surgery has been reported.
“This is the first international pharmacovigilance study focused specifically on a fixed dose ocular drop combining an antibiotic and an anti-inflammatory steroid,” said Dr. Giorgio Ciprandimain author of the publication. “Its broad use and favorable safety profile make it a precious option in the modern management of post-catracts patients.”
The results support the current recommendation of a short -term treatment course of seven days, which improves patient support and limits the risk of side effects or antibiotic resistance.
The study also highlights the importance of pharmacovigilance in the evaluation of drugs after market approval. “This analysis confirms how continuous safety monitoring is essential to protect patients and support clinicians according to the security information collected from spontaneous reports,” said Alessandro ColomboCSO in NTC.
Cataract surgery remains the most common ophthalmic procedure in the world, and postoperative management is essential to ensure optimal recovery. Since its approval in 2020, this innovative combination has provided patients with simplification a week The treatment regime which reduces unnecessary exposure to antibiotics and minimizes the risks associated with prolonged use of steroids.
Thanks to its coherent security profile, the product has received the renewal of the marketing authorization from European regulatory authorities.
About the study
The study, entitled “Pharmacovigilance on dexamethasone 1 mg / ml + levofloxacin 5 mg / ml of eye drops, solution: a five -year register.”was led by experts in ophthalmology and drug safety.
Source ntc srl
