Santen EMEA and NTC are delighted to announce that the results of their phase III clinical study, LEADER7, have been published in Eye. The study demonstrated for the first time that 7-day levofloxacin/dexamethasone eye drops were as effective as 14-day tobramycin/dexamethasone eye drops to treat ocular inflammation and prevent infection in post-cataract surgery patients.
The LEADER7 data establish that a fixed dose combination (FDC) of levofloxacin and dexamethasone eye drops for 7 days is as effective as the current standard tobramycin/ dexamethasone in treating cataract surgery patients prophylactically. This means that physicians are now able to effectively reduce the risks of infection or inflammatory complications, whilst reducing patients’ exposure time to antibiotics by a half.”
Prof. Francesco Bandello, University Vita-Salute (Milan, Italy) and Principal Investigator, LEADER7 study
LEADER7, an international, multi-centre, randomised, masked-assessor, parallel-group clinical study with 808 patients enrolled in 53 centres (Italy, Germany, Spain and Russia), evaluated the non-inferiority of 7-day levofloxacin/dexamethasone eye drops, followed by one week of dexamethasone alone, versus 14 days of tobramycin/dexamethasone (1 drop QID for all schedules).
The study showed that there was no statistically significant difference in patient outcomes following 7 days of levofloxacin/dexamethasone versus 14 days of tobramycin/ dexamethasone. The primary endpoint was the proportion of patients without signs of anterior ocular chamber inflammation after 14 days of treatment. Both treatments were generally well tolerated with no serious treatment-related adverse events (AEs) reported. Key findings included:
- No statistically significant difference in the proportion of patients without signs of inflammation in the anterior chamber. The intergroup difference was equal to −0.037 (95% CI: [−0.097; 0.024]) at day 4 and −0.012 (95% CI: [−0.060; 0.036]) at day 8
- No statistically significant differences in any of the secondary endpoints, with no cases of endophthalmitis reported
This levofloxacin/dexamethasone antibiotic/steroid FDC is indicated for the treatment of inflammation and prevention of infection associated with cataract surgery in adults. Currently, cataract surgery patients are prescribed a topical antibiotic/corticosteroid combination for 14 days, whereas levofloxacin/dexamethasone FDC offers a truncated 7-day combination treatment period.
As a global specialist in ophthalmology, we take our responsibility as a trusted partner to healthcare professionals and patients seriously. The results of the LEADER7 study are therefore encouraging, particularly given the growing prevalence of antibiotic resistant strains of bacteria, for which the risk of development can be exacerbated by longer antibiotic treatment regimes."
Luis Iglesias, President and Head of Santen EMEA
Antimicrobial resistance is an urgent healthcare priority that currently causes at least 700,000 deaths every year.2 Overuse and misuse are key factors in this growing issue that is estimated to kill approximately 10 million people by 2050 if no action is taken. As a trusted specialist in the ophthalmology community, Santen EMEA is committed to championing antibiotic stewardship in the field and encouraging all stakeholders to play their part in managing this global health issue.
Globally, cataract is one of the leading causes of vision impairment or blindness, affecting 65.2 million people. With more than 20 million procedures performed every year, cataract surgery can be considered one of the most common surgical intervention performed in the world. We are creating the path to a prophylaxis rationalisation for topical postoperative treatment of cataract.”
Riccardo Carbucicchio, President and CEO of NTC