U.S. FDA Accepts Allergan's New Drug Application for Bimatoprost Sustained-Release in Patients with Open-Angle Glaucoma or Ocular Hypertension
-- Filing included data from the Phase 3 ARTEMIS studies, which demonstrated that the majority of patients remained treatment free for at least 1 year following 3 treatments with Bimatoprost Sustained-Release --
-- Allergan continues advancement in eye care innovation, developing specialized treatments for patients --
DUBLIN, July 17, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company with more than 70 years of heritage in eye care, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for Bimatoprost Sustained-Release (SR). Bimatoprost SR if approved would be the first-in-class sustained-release, biodegradable implant for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. The FDA is expected to take action on the NDA by the end of the first half of 2020.
"With decades of experience researching and introducing innovative eye care treatments, we understand the importance of developing new and potentially sight-saving treatments for patients with glaucoma," said David Nicholson, Chief Research and Development Officer, Allergan. "The NDA is based on the positive results from the ARTEMIS Phase 3 studies and demonstrates our ongoing commitment to providing new treatments for patients living with glaucoma."
In the two Phase 3 ARTEMIS studies, Bimatoprost SR reduced intraocular pressure (IOP) by 30 percent over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator. The ARTEMIS studies evaluated 1,122 subjects on the efficacy and safety of Bimatoprost SR versus timolol, a FDA standard comparator for registrational clinical trials, in patients with open-angle glaucoma or ocular hypertension. After 3 treatments with Bimatoprost SR, greater than 80 percent of patients remained treatment free and did not need additional treatment to maintain IOP control for at least 12 months. Bimatoprost SR was well tolerated in the majority of patients.
"Millions of people are living with glaucoma, a progressive disease that requires sustained IOP control to preserve vision for patients," said Robert Weinreb, M.D., Chairman & Distinguished Professor of Ophthalmology and Director of the Shiley Eye Institute, San Diego. "Data from the ARTEMIS trials show Bimatoprost SR lowers IOP and maintains that effect for the majority of patients for one year after three administrations of the implant. Bimatoprost SR has the potential to be the first sustained-release option that could significantly shift the paradigm for treating glaucoma, a leading cause of blindness."
About Glaucoma and Long-Term Medication Compliance
Glaucoma is one of the primary causes of irreversible vision loss and blindness. In 2018, nearly 130 million people were living with glaucoma globally. This number is expected to rise to an estimated 148 million by 2023. This progressive disease is characterized by elevated IOP. Uncontrolled, elevated IOP causes damage to the optic nerve and loss of vision. Reduction of elevated IOP is the only proven way to slow the progression and vision loss associated with glaucoma.
Current treatments to lower IOP include topical medications (eye drops), laser trabeculoplasty, minimally invasive glaucoma surgery and incisional surgery. Eye drop medications are the standard first-line treatment for glaucoma, but low patient adherence to these medications is common – up to 80 percent of patients are not using topical medications as prescribed. Patients often find it difficult to adhere to their eye drop regimen every day, year after year, because they forget to take doses, cannot afford medications, do not understand their disease or have trouble instilling eye drops or sticking to the schedule. Poor adherence to topical medications relates directly to disease progression and vision loss. To remove long-term eye drop adherence as a factor in preserving vision, ophthalmologists rely on laser trabeculoplasty, minimally invasive glaucoma surgery (MIGS) and more invasive incisional surgeries and await the development of sustained-release medication.
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 social responsibility. Allergan, The Allergan Foundation and The Allergan International 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 (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader 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. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.
With colleagues and commercial operations located 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.
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 and Allergan's Quarterly Report on Form 10-Q for the period ended March 31, 2019. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.