NTC, the Italian pharmaceutical company, presented at the ESCRS (European Society of Cataract & Refractive Surgeons) Congress of Vienna the protocol of Leader7, one of the largest clinical trials in ophthalmology at European level of the last decade.
"Today old once upon-a-time effective antibiotics used in ophthalmology have developed during the last few decades strong resistances and their efficacy is at stake, to treat correctly the patients. Ophthalmology deserves to invest in new clinical evidences to support effective treatments and antibiotic prophylaxis in post cataract surgery while offering its contribution in the global fight of antibiotic resistance," said MD Francesco Bandello, Full Professor of Ophthalmology at University Vita-Salute, Ospedale San Raffaele of Milan, and Chairman of Leader7 study.
Leader7 is an international, multicenter, randomized, blinded-assessor, parallel-group clinical study comparing eye drops of the fixed combination levofloxacin 0.5% + dexamethasone 0.1% (a solution) for 7 days followed by dexamethasone 0.1% alone for an additional 7 days versus tobramycin + dexamethasone (a suspension) for 14 days for the treatment of inflammation and prevention of infection associated with cataract surgery in adults enrolling 800 patients in nearly 80 clinical centers in 4 European countries (Germany, Italy, Russia, Spain).
"The fixed combination of levofloxacine + dexamethasone in eye drops aims to represent an innovative therapeutic solution in post cataract surgery" - refers Federico Bertocchi, Chief Scientific Officer of NTC - "Thanks to its experimental design, for the first time the Leader7 study is designed to prove that a one-week course of antibiotic prophylaxis is equivalent to a two-week course. It is the first product combining a quinolone antibiotic with an anti-inflammatory steroid in eye drops in Europe".
The use of a fixed combination in ophthalmology is a growing standard, aiming at offering the best inflammation and pain control, together with an adequate powerful antibiotic protection.
"Inspired by World Health Organization programs targeting at fighting against antibiotic resistance, NTC is engaged in a variety of clinical programs designed to rationalize the use of antibiotic therapy in ophthalmology," says Riccardo Carbucicchio, CEO of NTC: "We are strongly committed in reducing the development of antibiotic resistance, offering novel clinical evidences in ophthalmology. This is the fight all pharmaceutical companies should be involved nowadays."
Among over 30 R&D projects running at present, mainly in ophthalmology, Leader7 represents a key pillar study among the NTC R&D investments.