Phase III trial success for brimatoprost SR in reduction of intraocular pressure.- Allergan

Allergan announced positive 3-month topline results from the second pivotal clinical trial of bimatoprost SR , a first-in-class sustained-release, biodegradable implant for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

In this Phase III 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 III 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. Positive results from the first Phase III trial were reported in June 2018. Bimatoprost SR is designed to lower IOP for at least 4 months, achieving clinical goals while freeing patients from daily eye drop regimens.

Comment: Allergan anticipates submitting a New Drug Application (NDA) to the FDA in the second half of 2019. Allergan is also conducting bimatoprost SR clinical trials for registration outside the United States which are ongoing.

Comment: A sustained-release Intracameral Drug Delivery System Applicator System was developed for Lumigan, at Allergan to evaluate anti-hypertensive therapies for the eye that do not require patient self-administration. The Bimatoprost PF IC DDS (preservative free intracameral drug delivery system) refers to the biodegradable preservative-free bimatoprost sustained-release implant.