Santen Pharmaceutical is one of the world’s leading specialist ophthalmic pharmaceutical companies, founded in Japan over a century ago and now serving patients all over the world.
Santen EMEA has recently announced the launch of Ducressa®, a fixed dose combination (FDC) of levofloxacin/dexamethasone eye drops solution that is indicated for the prevention and treatment of inflammation, and the prevention of infection associated with cataract surgery in adults.
Cataract surgery is Europe’s most frequently performed procedure in ophthalmology. The launch of this new prophylactic treatment, which reduces antibiotic exposure by a half, will enable ophthalmologists to contribute to global efforts to reduce potential antibiotic resistance.
Antimicrobial resistance is a global healthcare concern that currently causes at least 700,000 deaths every year.Δ Overuse and misuse, including exposure to long courses of antibiotics, are key factors in this growing issue that it is estimated will kill approximately 10 million people by 2050 if no action is taken.
Levofloxacin is a proven broad-spectrum antibiotic and dexamethasone, a potent anti-inflammatory agent. As an FDC, it is the first product available in Europe to combine a quinolone antibiotic with an anti-inflammatory steroid in eye drops.
“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,” said Prof. Marc Coassin, University of Rome, Italy.
The results of LEADER7, a large, 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 one-week levofloxacin/dexamethasone FDC eye drops, followed by one-week dexamethasone alone, versus the standard of two-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).Δ No statistically significant difference was evident in any of the other secondary endpoints, while both arms were well tolerated.
“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.” Ducressa has been launched to date in Denmark, Finland, Italy, Norway, Spain and Sweden with further launches expected across Europe in the coming months.