- These initial data show the potential for the vast majority of patients to remain treatment free for at least 1 year -
- Allergan plans US NDA submission in second half of 2019 -
DUBLIN, Jan. 7, 2019 /PRNewswire/ -- Allergan plc, (AGN), a leading global pharmaceutical company, today announced positive 3-month topline results from the second pivotal clinical trial of Bimatoprost SR, a first-in-class sustained-release, biodegradable implant for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. Positive results from the first Phase 3 trial were reported in June 2018. Bimatoprost SR is designed to lower IOP for at least 4 months, achieving clinical goals while freeing patients from daily eye drop regimens. Allergan anticipates submitting a New Drug Application (NDA) to the FDA in the second half of 2019. Allergan is also conducting Bimatoprost SR clinical trials for registration outside the United States which are ongoing.
In this Phase 3 clinical study of 528 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. Results of this second Phase 3 study with an identical design as the first study, showed that the magnitude of IOP-lowering efficacy with Bimatoprost SR is similar to that observed with topical prostaglandin analogues.
"The data results of intracameral Bimatoprost SR were consistently demonstrated in two pivotal trials, highlighting the sustained, predictable and potentially sight-saving benefits of this exciting new approach in treating patients with glaucoma," said David Nicholson, Chief Research and Development Officer, Allergan. "We are particularly encouraged by the long-term efficacy results leading to an extended treatment-free period."
The study also showed the potential for the vast majority of patients to remain treatment free for at least 1 year after the last implant was inserted. Overall, Bimatoprost SR was well tolerated in the majority of patients. The 20-month masked study is ongoing, and additional data will become available as patients complete the study.
"Glaucoma is the second leading cause of blindness in the world, making it essential to develop innovative new treatments and technologies that effectively address the underlying cause of the disease," said Bill Meury, Chief Commercial Officer, Allergan. "Bimatoprost SR represents an entirely new treatment approach for glaucoma that delivers a trusted medication in a way that may transform treatment for the tens of millions of people around the world with glaucoma and ocular hypertension."
"Bimatoprost SR has the potential to be the first sustained-release option of a drop-free therapy for patients who are suffering from glaucoma. Proper use of eye drops continues to be a concern for eye care professionals," 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. "With the long duration of effect observed in this study, Bimatoprost SR can be a significant paradigm shift for the treatment of glaucoma."
About the Bimatoprost SR 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 to timolol eye drops used twice daily for up to 20 months. Patients were 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) were used in the study eyes for masking purposes. The topline results are reported at the prespecified primary analysis time, 12 weeks after the last patient received the first implant.
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 effective way to stop 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 compliance as a factor in preserving vision, ophthalmologists rely on laser trabeculoplasty, MIGS and 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.
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 for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
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; 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, 2017 and Allergan's Quarterly Report on Form 10-Q for the period ended September 30, 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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