Allergan and Molecular Partners Present Late-Breaking Data from Phase 3 Studies of Investigational Abicipar pegol in Neovascular Wet Age-Related Macular Degeneration
Two-year results from CEDAR and SEQUOIA demonstrate that vision gains observed after one year with every 8-week and every 12-week dosing were maintained in the second year
Abicipar sustained vision gains in year two with quarterly injections compared to monthly ranibizumab
Reductions in central retinal thickness were lower in year two compared to year one for both quarterly and 8-week dosing arms of Abicipar and comparable to monthly ranibizumab
Data presented during Retina Subspecialty Day at American Academy of Ophthalmology Annual Meeting
DUBLIN, IRELAND – OCTOBER 11, 2019 – Allergan plc, (NYSE: AGN), a leading global pharmaceutical company with a more than 70-year heritage in ophthalmology and Molecular Partners (SIX: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin® therapies, today announced two-year data from the CEDAR and SEQUOIA clinical studies of investigational Abicipar in patients with neovascular (wet) age-related macular degeneration (nAMD). In the second year of these studies, four injections of Abicipar resulted in the maintenance of visual gains comparable to monthly ranibizumab. These data were presented as a late-breaking oral presentation during Retina Subspecialty Day at the Annual Meeting of the American Academy of Ophthalmology (AAO).
CEDAR and SEQUOIA are identical global Phase 3 studies designed to assess the efficacy and safety of Abicipar 8-week and 12-week treatment regimens compared with monthly ranibizumab in treatment-naïve patients with nAMD. Allergan previously announced that Abicipar met the prespecified primary end point of the proportion of patients with stable vision at week 52 demonstrating non-inferiority in both the 8-week and 12-week treatment regimens compared to monthly ranibizumab.
Through week 104, patients received Abicipar 2 mg every 8-weeks or every 12-weeks or ranibizumab 0.5 mg every 4 weeks. At week 104 in the pooled Phase 3 data, the proportion of patients with stable vision was 93%, 90% and 94% in 8-week Abicipar; 12-week Abicipar and 4-week ranibizumab treatment regimens, respectively. This continuation of stable vision in year 2 further reinforces the ability of Abicipar to deliver consistent quarterly dosing for the majority of patients.
“Current anti-VEGF treatments for neovascular age-related macular degeneration require frequent intravitreal injections,” said Rahul N. Khurana, M.D., Northern California Retina Vitreous Associates Medical Group. “Based on the results of CEDAR and SEQUOIA, which reinforce the efficacy of Abicipar while decreasing the number of injections, Abicipar could transform anti-VEGF treatment regimens.”
Mean changes in best-corrected visual acuity (BCVA) seen in year two were similar when compared to year one across all treatment arms. Central retinal thickness (CRT) continued to decrease during year two when compared to year one. CRT for patients treated with Abicipar dosed quarterly and every 8-weeks were similar to ranibizumab dosed every 4 weeks through week 104. Overall incidence rates of treatment-emergent adverse events at the end of year two were comparable between treatment groups. The pooled rate of new cases of intraocular inflammation in year two for patients who received Abicipar in the 8-and 12-week arms was 1.9%, which is similar to the ranibizumab arm of 1%.
“These late-breaking data further demonstrate the potential of Abicipar to provide consistent quarterly dosing that sustains vision gains in the majority of patients with neovascular age-related macular degeneration,” said David Nicholson, Chief Research and Development Officer, Allergan. “On the heels of regulatory filings for Abicipar in the United States and European Union, these data give us confidence in our ability to meet a serious unmet need for patients and eye doctors.”
“We are very excited at the continued success of Abicipar, our most advanced DARPin® molecule, in the treatment of patients with neovascular age-related macular degeneration,” Patrick Amstutz, PhD, CEO of Molecular Partners. “We are pleased to see a sustained response at two-years with less frequent dosing of Abicipar compared to standard of care therapy.”
The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are currently reviewing regulatory applications for Abicipar in patients with nAMD. The FDA is expected to take action on the BLA in mid-2020. A decision from the European Commission is expected in the second half of 2020.
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 for more than 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 (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 June 30, 2019. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
About Molecular Partners AG
Molecular Partners AG is a clinical-stage biopharmaceutical company that is developing a new class of therapies known as DARPin® therapies. With a management team that includes many of the founding scientists, the company continues to attract talented individuals who share the passion to develop breakthrough medicines for serious diseases. Molecular Partners has compounds in various stages of clinical and preclinical development and several more in the research stage, with a current focus on ophthalmology and oncology. The company establishes research and development partnerships with leading pharmaceutical companies and is backed by established biotech investors.