DucressaPostoperative ocular inflammation and infection in adults
Development and Regulatory status
Feb 21Santen launches Ducressa, after approval using the EMA decentralised procedure, in Denmark, Finland, Italy, Norway, Spain and Sweden, with further launches in Europe expected .
Fixed dose combination product combining a quinolone antibiotic with an anti-inflammatory steroid in eye drops
Globally, cataracts are the leading cause of blindness, responsible for 51% of world blindness, representing 20 million people in 2010. Cataracts are a global health priority for the WHO. The prevalence increases with age. In the UK, cataracts are thought to affect around half of those aged >65 years to some degree, rising to 70% in those aged >85yrs. Surgical removal of the cataract is the only effective treatment to restore or maintain vision. Pain and inflammation are common post surgery .
Postoperative ocular inflammation and infection in adults
Trial or other data
Feb 21The LEADER7 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, 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 .
Dec 18Primary outcome data collection completes in PIII LEADER7 trial .
Sep 18PIII LEADER7 trial to demonstrate the non-inferiority of the study treatment (combined levofloxacin + dexamethasone eye drops) followed by dexamethasone eye drops alone vs. standard treatment in the prevention and treatment of postoperative ocular inflammation and prevention of infection starts (NCT03739528). 808 adults due to have cataract surgery will be recruited in Italy. Patients will be randomised to levofloxacin 5 mg/ml + dexamethasone 1 mg/ml (7 days,1 drop/4 times a day) followed by dexamethasone 1 mg/ml (7 days,1 drop/4 times a day) OR tobramycin + dexamethasone (14 days, 1 drop/4 times a day). Primary outcome is number of participants without signs of anterior chamber inflammation (sum of cells and flare score = 0) at day 15 .