Allergan Presents EARLY Analysis Data at the American Academy of Ophthalmology (AAO) Annual Meeting

Analysis of Best Corrected Visual Acuity Data Assessed Response of an Anti-VEGF Therapy Over Time

Nov 13, 2015, 14:35 ET from Allergan plc

DUBLIN, Nov. 13, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company announced today that a post-hoc analysis of best corrected visual acuity (BCVA) data in diabetic macular edema (DME) patients treated with anti-vascular endothelial growth factor (anti-VEGF) therapy suggests that long-term response in anti-VEGF treatment of DME can be assessed after three injections.i This analysis, "Early Anti-VEGF Response and Long-term efficacY (EARLY Analysis)," is based on the Protocol I study, which was a three-year Phase III multicenter trial including 691 patients (854 study eyes) with DME conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net).I

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The DRCR.net is a collaborative effort sponsored by the National Eye Institute of the National Institutes of Health (U.S. Department of Health and Human Services) for facilitating clinical research of diabetic retinopathy, macular edema and associated retinal conditions.ii Allergan conducted this post-hoc analysis to support patient care in the management of DME. 

"The EARLY Analysis study has relevance for retinal physicians looking to assess how patients will respond to anti-VEGF treatment long-term," said Pravin Dugel, M.D., Clinical Professor, USC Eye Institute, Keck School of Medicine, University of Southern California and Managing Partner of Retinal Consultants of Arizona. "This data suggests that if treatment goals are not achieved after three injections, further expected improvement may be minimal and physicians may want to consider other treatment strategies."i 

This analysis of Protocol I looked at one anti-VEGF that is FDA-approved for the treatment of DME and assessed outcomes in three cohorts based on observed BCVA response, which was defined by letters gained on the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at week 12.i The cohorts were defined as a gain of less than five letters, a gain between five and nine letters and a gain of greater than or equal to 10 letters.i The unadjusted differences in mean BCVA change from baseline was +0.3, +6.9 and +15.2 at 12 weeks, respectively, and +3.0, +8.2 and +13.8 at three years, respectively.i After multivariate adjustment, significant correlation remained between BCVA gain at week 12 and years one and three (p <0.001).i

"DME is difficult to manage and it requires a customized patient approach," said David Nicholson, Ph.D., Executive Vice President, Global Brands R&D, Allergan. "The EARLY Analysis underscores Allergan's commitment to broadening our knowledge of the current landscape of DME treatment patterns." 

While additional analysis is needed to confirm these findings, the EARLY Analysis shares information that may help shape treatment patterns for patients with DME. 

About Diabetic Macular Edema
DME is a growing public health problem due to the increasing prevalence of diabetes.iii According to the U.S. Centers for Disease Control and Prevention, as of 2014, 29.1 million people — 9.3 percent of the U.S. population — have diabetes; 1.7 million new cases of diabetes were diagnosed in people aged 20 years or older in 2012.iv A high level of health care utilization is not surprising given the overall health status of this population.v

About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

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.

For more information, visit Allergan's website at www.allergan.com.

Allergan Forward-Looking Statement
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 of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. 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 risks associated with acquisition transactions; the difficulty of predicting the timing or outcome of FDA and other regulatory approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 (such periodic public filings having been filed under the "Allergan plc" or "Actavis plc" names) and from time to time in Allergan's other investor communications. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

[i] 2015. An Analysis of Diabetic Retinotherapy Clinical Research Network PROTOCOL I Data Study.
[ii] 2015. Diabetic Retinopath Clinical Research Network. Available at
  http://drcrnet.jaeb.org/ViewPage.aspx?PageName=General_Info.
[iii] Chen E, Looman M, Laouri M, Gallagher M, Van Nuys K, Lakdawall D, et al. Burden of illness on diabetic macular edema: literature review. Curr Med Res Opin. 2010;26:15871597.
[iv] National Diabetes Fact Sheet: National Estimates and General Information on Diabetes and Prediabetes in the United States, 2014. Atlanta (GA): Centers for Disease Control and Prevention; 2014.
[v] Shea AM, Curtis LH, Hammill BG, Kowalski JW, Ravelo A, Lee PP, et al. Resource use and costs associated with diabetic macular edema in elderly persons. Arch Ophthalmol. 2008;126:1748-1754.

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