Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Bayer Files Eylea for DME in EU | Contract Pharma

What are you searching for?

Sign in
Breaking News, Trials & Filings

Bayer Files Eylea for DME in EU

Would make third indication after AMD and CRVO

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Bayer HealthCare has submitted an MAA in the EU for Eylea (aflibercept) Injection for the treatment of patients with Diabetic Macular Edema (DME). Development partner Regeneron has submitted a supplemental BLA for Eylea in this indication to the FDA.

DME would be Eylea’s third indication in Europe. The submission for DME is based on data from the positive Phase III VISTA-DME and VIVID-DME studies. One-year data from both trials have been presented at medical conferences. The VISTA-DME and VIVID-DME trials are planned to continue up to 148 weeks.

Eylea was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012. Eylea has also been approved in the EU, Japan, Australia, and in several other countries for use in wet AMD. Eylea has also been approved by the European Commission for the treatment of visual impairment due to macular edema secondary to CRVO, as well as in selected countries in Asia and Latin America.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters

Topics