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, while the global pharmaceutical leader noted the positive results from the first Phase 3 trial were reported in June 2018.
Bimatoprost SR is aimed to lower IOP for at least 4 months, achieving clinical goals while freeing patients from daily eye drop regimens. Allergan plans to submitting a New Drug Application (NDA) to the FDA in the second half of 2019, and it will be conducting Bimatoprost SR clinical trials for registration outside the United States which are ongoing.
Allergans chief researcher, David Nicholson, said that 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. He said, “We are particularly encouraged by the long-term efficacy results leading to an extended treatment-free period.”
Allergan said that 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 Dublin-headquartered drugmaker’s boss, Bill Meury, reminded in the announcement that 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. He pointed out that 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.
Randy Craven, from Wilmer Eye Institute and Bethesda Johns Hopkins University School of Medicine said that Bimatoprost SR has the potential to be the first sustained-release option of a drop-free therapy for patients who are suffering from glaucoma. Craven said that proper use of eye drops continues to be a concern for eye care professionals. With the long duration of effect observed in this study, Bimatoprost SR can be a significant paradigm shift for the treatment of glaucoma.