{"id":38256,"date":"2025-07-17T09:00:00","date_gmt":"2025-07-17T09:00:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4727872_AE27872_0"},"modified":"2025-07-17T09:00:00","modified_gmt":"2025-07-17T09:00:00","slug":"five-year-pharmacovigilance-study-by-ntc-confirms-safety-of-fixed-dose-eye-drops-for-post-cataract-surgery","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=38256","title":{"rendered":"Five-year Pharmacovigilance study by NTC confirms safety of fixed-dose eye drops for Post-cataract Surgery"},"content":{"rendered":"<p> <span class=\"legendSpanClass\">MILAN<\/span>, <span class=\"legendSpanClass\">July 17, 2025<\/span> \/PRNewswire\/ &#8212;&nbsp;A recently published five-year pharmacovigilance study confirms the excellent safety profile of a fixed-dose combination eye drop containing an <b>anti-inflammatory steroid<\/b> and a <b>quinolone antibiotic<\/b>, developed by NTC, indicated for the prevention and treatment of inflammation and prevention of infection following cataract surgery in adults. The study was submitted when nearly <b>4 million patients<\/b> across about <b>60 countries worldwide <\/b>were treated with this drug.<\/p>\n<p>Conducted by Italian researchers and supported by NTC, the study analyzed public safety data registered in the adrreports.eu portal, that collects safety reports from <b>EudraVigilance<\/b>, the European Medicines Agency&#8217;s official adverse drug reaction (ADR) database. The study identified only <b>53 ADRs<\/b> occurred in <b>25 patients<\/b> between 2020 and 2024. Key findings include:<\/p>\n<ul type=\"disc\">\n<li> <b>74% of ADRs were non-serious<\/b>.<\/li>\n<li> <b>More than half were deemed unlikely to be related<\/b> to the product.<\/li>\n<li>The most frequently reported events were mild reactions involving the eye or skin\u2014expected outcomes for a topically administered ophthalmic solution.<\/li>\n<li> <b>No case of endophthalmitis<\/b>, a severe and rare infection that can occur following eye surgery, was reported.<\/li>\n<\/ul>\n<p>&#8220;This is the first international pharmacovigilance study focused specifically on a fixed-dose eye drop combining an antibiotic and an anti-inflammatory steroid,&#8221; said Dr. <b>Giorgio Ciprandi<\/b>, senior author of the publication. &#8220;Its wide usage and favorable safety profile make of it a valuable option in the modern management of post-cataract patients&#8217;.&#8221;<\/p>\n<p>The findings support the current recommendation of a short-term, seven-day treatment course, which improves patient adherence and limits the risk of side effects or antibiotic resistance.<\/p>\n<p>The study also highlights the importance of <b>pharmacovigilance<\/b> in evaluating medicines after market approval. &#8220;This analysis confirms how continuous safety monitoring is essential to protect patients and support clinicians based on safety information collected from the spontaneous reporting,&#8221; said <b>Alessandro Colombo<\/b>, CSO in NTC.<\/p>\n<p>Cataract surgery remains the most common ophthalmic procedure worldwide, and post-operative management is critical to ensure optimal recovery. Since its approval in 2020, this innovative combination has provided patients with a simplified <b>one-week<\/b> treatment regimen that reduces unnecessary exposure to antibiotics and minimizes the risks associated with prolonged steroid use.<\/p>\n<p>Thanks to its consistent safety profile, the product has received marketing authorization renewal from European regulatory authorities.<\/p>\n<p> <b>About the Study<\/b> <br \/>The study, titled <i>&#8220;Pharmacovigilance on dexamethasone 1mg\/mL + levofloxacin 5 mg\/mL eye drops, solution: a five-year registry.&#8221;<\/i>, was conducted by experts in ophthalmology and drug safety.<\/p>\n<p> <img decoding=\"async\" alt src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=AE27872&amp;Transmission_Id=202507170500PR_NEWS_ASPR_____AE27872&amp;DateId=20250717\"> <\/p>\n","protected":false},"excerpt":{"rendered":"<p>MILAN, July 17, 2025 \/PRNewswire\/ &#8212;&nbsp;A recently published five-year pharmacovigilance study confirms the excellent safety profile of a fixed-dose combination eye drop containing an anti-inflammatory steroid and a quinolone antibiotic, developed by NTC, indicated for the prevention and treatment of inflammation and prevention of infection following cataract surgery in adults. The study was submitted when [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-38256","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Five-year Pharmacovigilance study by NTC confirms safety of fixed-dose eye drops for Post-cataract Surgery - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=38256\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Five-year Pharmacovigilance study by NTC confirms safety of fixed-dose eye drops for Post-cataract Surgery - My Blog\" \/>\n<meta property=\"og:description\" content=\"MILAN, July 17, 2025 \/PRNewswire\/ &#8212;&nbsp;A recently published five-year pharmacovigilance study confirms the excellent safety profile of a fixed-dose combination eye drop containing an anti-inflammatory steroid and a quinolone antibiotic, developed by NTC, indicated for the prevention and treatment of inflammation and prevention of infection following cataract surgery in adults. 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