Santen EMEA and NTC, have announced the completion and positive outcome of the European Decentralised Procedure (DCP) for a fixed dose combination of levofloxacin and dexamethasone (Ducressa), offering reduced exposure to antibiotics following cataract surgery.1 Levofloxacin is a broad spectrum antibiotic, and dexamethasone, a potent anti-inflammatory agent. Germany acted as the Reference Member State (BfArM) on behalf of 27 European Economic Area (EEA) states.*
“Cataract is the leading cause of blindness and cataract surgery is the most common operation performed worldwide,” Luis Iglesias, President and Head of Santen EMEA, said in a company news release. “Antibiotic treatment is essential to prevent infection following cataract surgery. However, the risk of antibiotic resistance to patients and to society at large is real and increasing. With the positive outcome of the DCP, cataract surgery patients are one step closer to a one week antibiotic treatment and reduced exposure time compared to standard antibiotic courses.”
“Our levofloxacin and dexamethasone FDC represents a new treatment strategy that can also lead to a re-evaluation on whether there is a need for routine steroid therapy beyond 1 week after cataract surgery. And this would be a clear benefit for both patients and their doctors as shortening corticosteroid treatment may prevent common adverse reactions linked to this class of medicines,” added Riccardo Carbucicchio, President and CEO of NTC.
Levofloxacin/dexamethasone, the first product combining a quinolone antibiotic with an anti-inflammatory steroid in eye drops in Europe, is indicated for the prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults.1 Currently, cataract surgery patients are usually prescribed a topical antibiotic/corticosteroid combination for 14 days, whereas levofloxacin/dexamethasone offers a truncated 7 day combination treatment period.1
The results of LEADER7, a large, 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 1-week levofloxacin/dexamethasone eye drops, followed by 1-week dexamethasone alone, versus the gold-standard of 2-week tobramycin/dexamethasone. The study showed that 95.2% of the patients in the test arm versus 94.9% of the control arm had no signs of inflammation in the anterior chamber (difference between proportions of patients = 0.028; 95% CI: -0.0275 / 0.0331). No statistically significant difference was evident in any of the other secondary endpoints, whilst both treatments were generally well tolerated.1
Submissions will now be made to the relevant authorities in all 27 EEA states, to seek consideration for marketing authorization for levofloxacin/dexamethasone.
*The 27 EEA states that the DCP apply to are Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.
- Bandello F., et al. One week of levofloxacin plus dexamethasone eye drops for cataract surgery: an innovative and rational therapeutic strategy. Eye (2020), https://doi.org/10.1038/s41433-020-0869-1