Santen and NTC Release Results of Phase 3 Clinical Study Examining 7-Day Fixed Dose Combination of Levofloxacin

Santen EMEA and NTC have announced that the results of their phase 3 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.[1]

“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,” Prof. Francesco Bandello, University Vita-Salute (Milan, Italy) and Principal Investigator, LEADER7 study, said in a company news release. “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.”

LEADER7, an international, multicenter, randomised, masked-assessor, parallel-group clinical study with 808 patients enrolled in 53 centres (Italy, Germany, Spain and Russia), evaluated the noninferiority of 7-day levofloxacin/dexamethasone eye drops, followed by 1 week of dexamethasone alone, versus 14 days of tobramycin/dexamethasone (1 drop QID for all schedules).[1]

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.