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 IOP in patients with open-angle glaucoma or ocular hypertension. Positive results from the first phase 3 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. 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.
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 noninferiority 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 data results of intracameral Bimatoprost SR were consistently demonstrated in two pivotal trials, highlighting the sustained, predictable and potentially sight-saving benefits of this exciting new approach in treating patients with glaucoma,” David Nicholson, Chief Research and Development Officer, Allergan, said in a company 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.
“Glaucoma is the second leading cause of blindness in the world, making it essential to develop innovative new treatments and technologies that effectively address the underlying cause of the disease,” Bill Meury, Chief Commercial Officer, Allergan, said in a company news release. “Bimatoprost SR represents an entirely new treatment approach for glaucoma that delivers a trusted medication in a way that may transform treatment for the tens of millions of people around the world with glaucoma and ocular hypertension.”
“Bimatoprost SR has the potential to be the first sustained-release option of a drop-free therapy for patients who are suffering from glaucoma. Proper use of eye drops continues to be a concern for eye care professionals,” said Randy Craven, MD, Chief, Wilmer Eye Institute at Bethesda, Vice Chair of Wilmer Practice Network and Associate Professor at Johns Hopkins University School of Medicine. “With the long duration of effect observed in this study, Bimatoprost SR can be a significant paradigm shift for the treatment of glaucoma.”
About the Bimatoprost SR Study Design
This multicenter, randomized, masked, parallel-group study in patients with open-angle glaucoma or ocular hypertension compares the efficacy and safety of 2 dose strengths of Bimatoprost SR to timolol eye drops used twice daily for up to 20 months. Patients were randomized to receive 3 administration cycles (Day 1, Week 16 and Week 32) of Bimatoprost SR or twice-daily timolol eye drops in the study eyes. Vehicle eye drops or sham administrations (Day 1, Week 16 and Week 32) were used in the study eyes for masking purposes. The topline results are reported at the prespecified primary analysis time, 12 weeks after the last patient received the first implant.