Allergan announced the release of new topline clinical trial data on Bimatoprost SR, a sustained-release, biodegradable implant for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. Bimatoprost SR is designed to lower IOP for at least 4 months, achieving clinical goals while freeing patients from daily eye drop regimens.
In this first phase 3 clinical study of 594 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. This initial data showed the potential for the majority of patients to remain treatment free for 1 year after the last implant was inserted. The magnitude of IOP lowering efficacy with Bimatoprost SR observed in this study is similar to that observed with daily topical prostaglandin analogues. Bimatoprost SR was also well tolerated in the majority of patients. Additional safety data from this study and results from a second phase 3 study with an identical design will be reported in the first half of 2019. An NDA filing to the FDA is expected in the second half of 2019.
“Effective sustained-release, IOP-lowering medication has been an aspiration of the glaucoma specialty for many years,” David Nicholson, Chief Research and Development Officer, Allergan, said in a company news release. “In Allergan’s long history of innovative treatments for glaucoma and other eye diseases, this first-in-class Bimatoprost SR data represent a major milestone of which we are very proud.”
“Bimatoprost SR has the potential to be the first sustained-release option of a drop-free therapy for patients who are suffering from glaucoma. This is a real potential paradigm shift in our options to lower eye pressure in patients with glaucoma,” 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.
“Considering that as many as 80 percent 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. Allergan’s deep glaucoma heritage provides a strong platform to bring Bimatoprost SR to physicians and their patients,” said Bill Meury, Chief Commercial Officer, Allergan.
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 two dose strengths of Bimatoprost SR (after single and repeat administrations) to timolol eye drops used twice daily for up to 20 months. The patients are randomized to receive three 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) are used in the study eyes for masking purposes.