- New data to address the treatment duration potential of first-in-class sustained release biodegradable implant -
- US NDA submission expected in second half of 2019 -
DUBLIN, March 14, 2019 /PRNewswire/ -- Allergan plc, (NYSE:AGN), a leading global pharmaceutical company with more than 70 years of heritage in eye care, will present new data including a late-breaking abstract for Bimatoprost SR at the Annual Meeting of the American Glaucoma Society (AGS) to be held in San Francisco, California. The late-breaking abstract, to be presented for the first time during a podium session on Saturday, March 16th, is the initial treatment duration analysis of Phase 3 clinical data for Bimatoprost SR, a first-in-class sustained-release, biodegradable implant being evaluated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Topline Phase 3 efficacy and safety results from the ongoing studies will also be presented at a congress later this year. Allergan anticipates submitting a New Drug Application (NDA) to the FDA in the second half of 2019.
"This first presentation showing the treatment duration from the Phase 3 studies confirms that Bimatoprost SR could represent a major paradigm shift in the management of glaucoma. Bimatoprost SR demonstrated an extended duration of effect in many patients, and the potential for most patients to need no additional treatment for one year after three administrations of the implant," said Yehia Hashad, MD, Vice President and Global Head, Clinical Development, Eye Care, Allergan. "The development of Bimatoprost SR demonstrates our continued commitment to developing innovative therapies for glaucoma, a progressive disease that requires consistent IOP control to preserve vision for patients."
Allergan will present two abstracts, including one podium presentation (accepted as a late-breaking abstract) and one poster presentation (all noted in local Pacific Standard Time):
AGS Poster Session (Friday, March 15, 7:00 AM - 5:00 PM):
- Logistic Regression Analysis of Baseline Patient Characteristics Predicting IOP Control Up to 24 Months After a Single Administration of Bimatoprost SR
- Author: Ahmed IIK et al
AGS Podium Session (Saturday, March 16, 4:35 PM):
- Extended Duration of IOP Control with Intracameral Bimatoprost Sustained-Release Implant (Bim SR): Late-Breaking Phase 3 Clinical Trial Results
- Author: Ahmed IIK et al
- Time: 4:35 PM
About Allergan plc
Allergan plc (NYSE:AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology.
Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.
Allergan's success is powered by our global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
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 every day.
For more information, visit Allergan's website at www.Allergan.com.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2018. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
Manisha Narasimhan, PhD
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