Allergan announces 'positive' 3-month topline results from the second pivotal clinical trial of Bimatoprost SR for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension
In this Phase 3 clinical study of 528 subjects with open-angle glaucoma or ocular hypertension, Bimatoprost SR reduced IOP by approximately 30 percent over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator, timolol. Results of this second Phase 3 study with an identical design as the first study, showed that the magnitude of IOP-lowering efficacy with Bimatoprost SR is similar to that observed with topical prostaglandin analogues. The study also showed the potential for the vast majority of patients to remain treatment free for at least 1 year after the last implant was inserted. Overall, Bimatoprost SR was well tolerated in the majority of patients. The 20-month masked study is ongoing, and additional data will become available as patients complete the study.