Bimatoprost sustained-release implant shows positive phase 3 data
A bimatoprost sustained-release implant reduced IOP by approximately 30% over 12 weeks in a phase 3 clinical study, according to an Allergan press release.
The multicenter, randomized, masked, parallel-group study, which included 594 subjects with open-angle glaucoma or ocular hypertension, compared the efficacy and safety of two dose strengths of Bimatoprost SR and timolol eye drops used twice daily for up to 20 months. The study showed the majority of patients treated with Bimatoprost SR were potentially able to be treatment-free for 1 year after the last implant was inserted, the release said.
“Considering that as many as 80% of glaucoma patients fail to administer their drops on a regular basis, Bimatoprost SR has the potential to transform the management of glaucoma in millions of patients,” Bill Meury, chief commercial officer at Allergan, said in the release.
The implant was well tolerated in the majority of patients. Additional safety data from this study, as well as results from a second phase 3 study, are expected to be reported in the first half of 2019, and the company expects to file a new drug application with the FDA in the second half of 2019, according to the release.