-New data will provide insights on treatment duration and biodegradation of the experimental implant in patients with open-angle glaucoma or ocular hypertension-
-Company also will present a late-breaking abstract on XEN Gel Stent-
DUBLIN, May 3, 2019 /PRNewswire/ -- Allergan plc, (AGN), a leading global pharmaceutical company with a heritage of more than 70 years in eye care, will present new data for its investigational implant, Bimatoprost SR, and a late-breaking analysis on its subconjunctival gelatin implant, XEN Gel Stent, at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting to be held in San Diego, California from May 3rd – 7th. During a podium session on Sunday, May 5th, Allergan will present an analysis exploring the treatment duration of Bimatoprost SR and a separate presentation on the biodegradation data from a Phase 1/2 study. These presentations follow data that was presented at the most recent Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.
"The data presented at ASCRS underscores our commitment to turning innovative research into meaningful treatment options that improve the experience for patients with open-angle glaucoma or ocular hypertension," said Yehia Hashad, M.D., Senior Vice President, Head of Global Clinical Development, Allergan. "Building upon the intraocular pressure lowering control of Bimatoprost SR seen in our Phase 3 trials, this new data provides insights into how the duration of treatment and rate of biodegradation may factor into the medicine's overall effectiveness."
Bimatoprost SR is a first-in-class sustained-release, biodegradable implant being evaluated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. Topline Phase 3 efficacy and safety results from ongoing studies will 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.
The data analysis from a Phase 1/2, 24-month, prospective, multicenter, dose-ranging study of 75 open-angle glaucoma patients evaluated the rate of biodegradation on the implant and the impact on the intraocular pressure (IOP) lowering effect of Bimatoprost SR. A second analysis of data from the Phase 1/2 and Phase 3 clinical studies assessed the duration of IOP control based on the time after administration of Bimatoprost SR without the use of other IOP-lowering therapies.
Allergan will present two abstracts as podium presentations and will have one late-breaking abstract (all noted in local Pacific Time):
- Duration of Effect of Intracameral Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Phase 1/2 and Phase 3 Clinical Studies
- Biodegradation of Intracameral Bimatoprost Sustained-Release Implant (Bimatoprost SR) in a 24-Month, Phase 1/2 Study in Glaucoma Patients
- Effectiveness and Safety of the Subconjunctival Gelatin Implant Alone or Combined with Cataract Surgery
Disclaimer: All educational content of the ASCRS•ASOA Annual Meeting is planned by its program committee, and ASCRS•ASOA does not endorse, promote, approve, or recommend the use of any products, devices, or services.
The XEN® Glaucoma Treatment System (XEN® 45 Gel Stent preloaded into a XEN® Injector) is indicated for the management of refractory glaucomas, including cases where previous surgical treatment has failed, cases of primary open-angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.
IMPORTANT SAFETY INFORMATION
XEN® Gel Stent is contraindicated in angle-closure glaucoma where angle has not been surgically opened, previous glaucoma shunt/valve or conjunctival scarring/pathologies in the target quadrant, active inflammation, active iris neovascularization, anterior chamber intraocular lens, intraocular silicone oil, and vitreous in the anterior chamber.
XEN® Gel Stent complications may include choroidal effusion, hyphema, hypotony, implant migration, implant exposure, wound leak, need for secondary surgical intervention, and intraocular surgery complications. Safety and effectiveness in neovascular, congenital, and infantile glaucoma has not been established. Avoid digital pressure following implantation of the XEN® Gel Stent to avoid the potential for implant damage.
Examine the XEN® Gel Stent and XEN® Injector in the operating room prior to use. Monitor intraocular pressure (IOP) postoperatively and if not adequately maintained, manage appropriately. Stop the procedure immediately if increased resistance is observed during implantation and use a new XEN® system. Safety and effectiveness of more than a single implanted XEN® Gel Stent has not been studied.
The most common postoperative adverse events included best-corrected visual acuity loss of ≥ 2 lines (≤ 30 days 15.4%; > 30 days 10.8%; 12 months 6.2%), hypotony IOP < 6 mm Hg at any time (24.6%; no clinically significant consequences were associated, no cases of persistent hypotony, and no surgical intervention was required), IOP increase ≥ 10 mm Hg from baseline (21.5%), and needling procedure (32.3%).
Caution: Federal law restricts this device to sale by or on the order of a licensed physician. For the full Directions for Use, please visit www.allergan.com/xen/usa.htm or call 1-800-678-1605. Please call 1-800-433-8871 to report an adverse event.
About Allergan Eye Care
As a leader in eye care, Allergan has discovered, developed, and delivered some of the most innovative products in the industry over the last 70 years. Allergan has launched over 125 eye care products and invested billions of dollars in new treatments for the most prevalent eye conditions including glaucoma, ocular surface disease, and retinal diseases such as diabetic macular edema and retinal vein occlusion. Our eye care pipeline includes 13 additional agents for multiple ocular conditions.
Our commitment to the well-being of patients is also reflected in philanthropy. Allergan and The Allergan Foundation support more than 150 organizations around the world working to improve lives and communities. We remain steadfast in helping eye care providers deliver the best in patient care through innovative products and outreach programs.
About Allergan plc
Allergan plc (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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