Allergan, Inc. issued the following announcement on June 13.
Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, today announced the release of new topline clinical trial data on Bimatoprost SR, the first-in-class sustained-release, biodegradable implant for the reduction of intraocular pressure (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 non-inferiority to the study comparator, timolol. This initial data showed the potential for the majority of patients to remain treatment free for one 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," said David Nicholson, Chief Research and Development Officer, Allergan. "In Allergan's long history of innovative treatments for glaucoma and other eye diseases, this first-in-class Bimatoprost SR data represents 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.
Original source can be found here.
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