Santen Launches Ducressa Post-Cataract Surgery Antibiotic/Steroid Combination

Santen EMEA has announced the launch of Ducressa, a fixed dose combination of levofloxacin/dexamethasone eye drops solution indicated for the prevention and treatment of inflammation, and the prevention of infection associated with cataract surgery in adults.[1] The launch of this new prophylactic treatment, which reduces antibiotic exposure by a half [1], will enable ophthalmologists to contribute to global efforts to reduce potential antibiotic resistance.

Levofloxacin is a proven broad-spectrum antibiotic and dexamethasone, a potent anti- inflammatory agent. As an fixed dose combination, it is the first product available in Europe to combine a quinolone antibiotic with an anti-inflammatory steroid in eye drops, according to Santen. Currently, cataract surgery patients are usually prescribed a topical antibiotic/corticosteroid combination for 14 days, whilst Ducressa offers a shorter 7 day combination treatment period.

“We know that the overuse and misuse of antibiotics has accelerated the development of new gene mutations that can lead to antibiotic resistance. With the launch of this new fixed dose combination of levofloxacin and dexamethasone, many ophthalmologists now have a new approach in their practice to prevent infection in their cataract surgery patients, whilst playing their part in combating this global health concern,” Prof. Marc Coassin, University of Rome, Italy, said in a company news release.

The results of LEADER7, a large, international, multicenter, randomized, masked-assessor, parallel-group clinical study, with 808 patients enrolled in 53 centers (Italy, Germany, Spain and Russia), evaluated the noninferiority of 1-week levofloxacin/dexamethasone fixed dose combination eye drops, followed by 1-week dexamethasone alone, versus the standard of 2-week tobramycin/dexamethasone. The study met its primary endpoint and showed that 95.2% of 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, while both arms were well tolerated.[1]

“Cataract is one of the most common and indeed treatable causes of partial or complete blindness. Cataract surgery therefore is the most performed operation worldwide in ophthalmology,” said Luis Iglesias, President and Head of Santen EMEA. “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 launch of Ducressa, cataract surgery patients across Europe will be able to access a one-week antibiotic treatment.”