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Positive Phase I/II Interim Data of Bimatoprost Sustained-Release Implant for IOP Therapy in Glaucoma

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Monday, November 16, 2015

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DUBLIN - Allergan plc (NYSE: AGN) announced today the 6-month interim results from a 24-month Phase I/II clinical trial of 75 patients, which showed that a single dose of Bimatoprost Sustained-Release (SR) lowered intraocular pressure (IOP) in 92 percent (n= 69) of glaucoma patients at 4 months and 71 percent (n=53) at 6 months while demonstrating a favorable efficacy and safety profile. Bimatoprost SR is a biodegradable, intracameral implant providing slow release of bimatoprost and is a differentiated approach to treat glaucoma beyond conventional daily eye drop treatments because it is a non-daily treatment administered by a physician.

"We are encouraged by these interim results, and Phase III trials are currently underway," said David Nicholson, Ph.D., Executive Vice President and President, Global Brands Research & Development, Allergan. "Bimatoprost SR has the potential to be a novel approach to treat glaucoma beyond conventional eye drop treatments and illustrates our commitment to bringing innovative solutions for physicians to help them meet the needs of their patients."

In the Phase I/II dose-ranging, paired-eye controlled clinical trial, a total of 75 patients received the implant via an intracameral injection in one eye, and daily topical bimatoprost 0.03% in the other eye. The dose strengths of Bimatoprost SR were 6, 10, 15, or 20 micrograms. All dose strengths of Bimatoprost SR were comparable with topical bimatoprost 0.03% in overall IOP reduction through week 16. The overall mean IOP reduction from baseline at 4 months in study eyes that received a single Bimatoprost SR implant ranged from 7.2 to 9.5 mm Hg while pooled fellow eyes receiving once-daily treatment with topical bimatoprost 0.03% had a reduction of 8.4 mm Hg. At month 6, 71 percent (n=53) of study eyes still had not received topical IOP-lowering rescue or a second injection of Bimatoprost SR.

"Patients having challenges in taking their daily eye drops is one of the greatest challenges we face as eye care physicians," said Richard Lewis, M.D., clinical trial investigator, former director of glaucoma at the University of California, Davis, and ophthalmologist at Sacramento Eye Consultants. "The results seen to date indicate that Bimatoprost SR may offer patients a non-daily treatment option that is administered by a physician."

There were no serious ocular adverse events in the study eye, and majority of the most common adverse events (conjunctival hyperemia, foreign body sensation, eye pain, lacrimation increase) were related to the injection procedure, graded as mild by the investigator.

About the Trial
Ongoing Phase I/II, prospective, 24-month, dose-ranging, paired-eye, controlled clinical trial. The objective of the trial is to evaluate the safety and efficacy of Bimatoprost SR in lowering IOP in patients with open angle glaucoma and ocular hypertension. Rescue with topical IOP-lowering medication was required by only 4 (5.3 percent) study eyes up to week 12 and 6 (8 percent) study eyes up to week 16. After 12 weeks, Bimatoprost SR continued to provide statistically significant (P≤.001) IOP lowering through 6 months of follow-up.

About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

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Lisa DeFrancesco
(862) 261-7152

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Mark Marmur
(973) 906-1526

Jessica Chao
(714) 246-3151

Source: Allergan, Inc.
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