A new ‘made in Italy’ eye drops are available in pharmacies in the Peninsula for the prevention and treatment of inflammation and for the prevention of infection associated with cataract surgery in adults. The drug, developed by Ntc, is the first to combine the broad spectrum fluoroquinolone antibiotic levofloxacin with dexamethasone, a reference cortisone in ophthalmology. The product, reports the company, halves the duration of administration of the therapy after the operation. “Cataract is one of the most performed operations in the world and over the years the surgical technique has made great strides, becoming more and more precise and accurate – explains Edoardo Ligabue, coordinator of the Ophthalmology and Eye Surgery Service, Italian Diagnostic Center (Cdi) – Unfortunately the same cannot be said for the post-operative therapeutic strategies, which have been the same for 40 years and are based on the administration of antibiotics and steroids for 14 days. This new ‘2 in 1’ formulation represents a step forward in management post-surgical cataract. Facilitates administration, improving therapeutic adherence, also in consideration of the fact that it is mostly elderly patients who struggle to juggle two different drugs, and at the same time has an important impact in duration of the treatment “. To demonstrate the efficacy of the eye drops – reads a note – Ntc has designed and conducted Leader7, a clinical study of phase 3 mul ticentric and international, blinded randomized to parallel groups, on 800 patients from over 50 facilities. The trial demonstrated non-inferiority of one week treatment with levofloxacin / dexamethasone followed by administration of dexamethasone alone for an additional 7 days, compared to tobramycin and dexamethasone therapy for 2 weeks. In addition, it was found that 85% of people treated for one week with the fixed combination levofloxacin-dexamethasone showed no signs of ocular inflammation, showing that using corticosteroids for 7 days is sufficient to control inflammation in the overwhelming majority of patients. “This is the first study to compare two regimens of topical antibiotic prophylaxis of different duration – underlines Luca Rossetti, professor at the State University of Milan, director of the Asst Santi Paolo e Carlo eye clinic in the Lombard capital – The reduction 14 to 7 days of post-operative treatment is a very important aspect because it offers the opportunity on the one hand to optimize the use of corticosteroids and therefore reduce the associated side effects, and on the other hand to reduce the time of exposure to antibiotics and, consequently, to lower the likelihood of resistance. Finally, the shorter duration of treatment, insi heme to the convenience of having both active ingredients in the same eye drops, is an important aspect to improve adherence to therapy for people who have undergone cataract surgery “.” Cataract surgery is one of the most frequent ophthalmic interventions in around the world, with about 600 thousand interventions a year in Italy, and for this reason we are very happy to have devised and made available a solution that can simplify the lives of many people – says Riccardo Carbucicchio, president and CEO of Ntc – It is was a major challenge in pharmaceutical technology because the two molecules in one solution were unstable. Furthermore, the fight against antibiotic resistance is a relevant issue for Ntc and we are proud to be able to offer a new solution in this direction. An indicator of the value of this product is also the fact that we have granted it in 5 continents to partners in over 80 countries. For Ntc it is the first truly global product. made in Italy”.
