Allergan Announces Positive Topline Phase 3 Clinical Data for Bimatoprost SR (Sustained-Release) Implant for IOP Lowering in Patients with Open-Angle Glaucoma or Ocular Hypertension
-An investigational implant being developed as the first sustained-release drop-free treatment option for patients-
-Data showed potential for majority of patients to remain treatment free for one year-
DUBLIN /PRNewswire/ -- Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, today 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 (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.
In this first Phase 3 clinical study of 594 subjects with open-angle glaucoma or ocular hypertension, Bimatoprost SR reduced IOP by approximately 30 percent over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator, timolol. This initial data showed the potential for the majority of patients to remain treatment free for one year after the last implant was inserted. 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. Additional safety data from this study and results from a second Phase 3 study with an identical design will be reported in the first half of 2019. An NDA filing to the FDA is expected in the second half of 2019.
"Effective sustained-release, IOP-lowering medication has been an aspiration of the glaucoma specialty for many years," said David Nicholson, Chief Research and Development Officer, Allergan. "In Allergan's long history of innovative treatments for glaucoma and other eye diseases, this first-in-class Bimatoprost SR data represents a major milestone of which we are very proud."
"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, MD, Chief, Wilmer Eye Institute at Bethesda,Vice Chair of Wilmer Practice Network and Associate Professor at Johns Hopkins University School of Medicine.
"Considering that as many as 80 percent of glaucoma patients fail to administer their drops on a regular basis, Bimatoprost SR has the potential to transform the management of glaucoma in millions of patients. Allergan's deep glaucoma heritage provides a strong platform to bring Bimatoprost SR to physicians and their patients," said Bill Meury, Chief Commercial Officer, Allergan.
About the Bimatoprost Study Design
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.
About Glaucoma and Long-Term Medication Compliance
Glaucoma is one of the primary causes of irreversible vision loss and blindness. In 2010, 60.5 million people in the world were living with glaucoma, a number that is expected to rise to nearly 80 million by 2020. 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 effective way to stop progression and vision loss associated with glaucoma.
Current treatments to lower IOP include topical medications (eye drops), laser trabeculoplasty, minimally invasive glaucoma surgery (MIGS), 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 compliance as a factor in preserving vision, ophthalmologists rely on laser trabeculectomy, MIGS & more invasive incisional surgeries and await the development of sustained-release medication.
Allergan: 70 Years Advancing 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.
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; uncertainty associated with financial projections, projected cost reductions, 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, 2017 and Allergan's Quarterly Report on Form 10-Q for the period ended March 31, 2018. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.