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Allergan Reports Positive Topline Phase 3 Clinical Data For Bimatoprost SR

Allergan plc (AGN) 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 or 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, Allergan noted.

In this first Phase 3 clinical study of 594 subjects with open-angle glaucoma or ocular hypertension, Bimatoprost SR reduced IOP by about 30 percent over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator, timolol.

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, after single and repeat administrations, to timolol eye drops used twice daily for up to 20 months.

The patients are 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) are used in the study eyes for masking purposes.

The initial data showed the potential for the majority of patients to remain treatment free for one year after the last implant was inserted, Allergan said.

According to the company, 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.

Allergan will report additional safety data from this study and results from a second Phase 3 study with an identical design in the first half of 2019. An NDA filing to the FDA is expected in the second half of 2019.

"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, Chief of Wilmer Eye Institute at Bethesda,Vice Chair of Wilmer Practice Network and Associate Professor at Johns Hopkins University School of Medicine.

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