■ Allergan released positive 3-month top-line results from the second pivotal clinical trial of Bimatoprost SR, a first-in-class sustained-release, biodegradable implant for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. Positive results from the first phase 3 trial were previously reported. Bimatoprost SR is designed to lower IOP for at least 4 months, achieving clinical goals while freeing patients from daily eye drop regimens. Allergan expects to submit a new drug application (NDA) to the FDA in the second half of 2019.
In this phase 3 clinical study of 528 subjects with open-angle glaucoma or ocular hypertension, Bimatoprost SR reduced IOP by approximately 30% during the 12-week primary efficacy period, meeting the predefined criteria for noninferiority to the study comparator, timolol. Results of this second phase 3 study, which had an identical design to the first study, showed that the magnitude of IOP-lowering efficacy with Bimatoprost SR is similar to that observed with topical prostaglandin analogues.
“The data results of intracameral Bimatoprost SR were consistently demonstrated in 2 pivotal trials, highlighting the sustained, predictable, and potentially sight-saving benefits of this exciting new approach in treating patients with glaucoma,” said David Nicholson, chief research and development officer at Allergan, in a news release. “We are particularly encouraged by the long-term efficacy results leading to an extended treatment-free period.”
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.