Summary
Regeneron Pharmaceuticals, Inc. (REGN) announced on June 17, 2011, a significant positive development for its lead product candidate, EYLEA™ (aflibercept ophthalmic solution), also known as VEGF Trap-Eye. The Dermatologic and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously to recommend the approval of EYLEA™ for the treatment of wet age-related macular degeneration (AMD). This unanimous recommendation from the FDA advisory committee is a critical step towards potential market approval and represents strong clinical validation for EYLEA™. The recommended dosing regimen is 2 mg every eight weeks, following an initial three doses every four weeks. This positive outcome is a key event for investors, signaling a potential major new revenue stream for Regeneron in the ophthalmology market.
Key Highlights
- 1FDA Advisory Committee unanimously recommended approval for EYLEA™ (aflibercept ophthalmic solution) for wet AMD.
- 2EYLEA™ is also known as VEGF Trap-Eye.
- 3The recommended dosing for EYLEA™ is 2 mg every eight weeks after initial loading doses.
- 4This recommendation is a crucial step towards potential market approval by the FDA.
- 5The event date was June 19, 2011, with the press release issued on June 17, 2011.
- 6This filing is an 8-K report, specifically under Item 8.01 Other Events and Item 9.01 Exhibits.