Tag Archives: Eylea

September, 2018

13 September
FDA to Review Regeneron’s sBLA of Eylea Injection for the Treatment of Diabetic Retinopathy

TARRYTOWN, N.Y., Sept. 13, 2018 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.(NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) of EYLEA®(aflibercept) Injection for the treatment of diabetic retinopathy (DR), the leading cause of vision loss for patients with diabetes. The target action …
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17 August
FDA Approves Regeneron’s Eylea Injection sBLA in Wet Age-Related Macular Degeneration

TARRYTOWN, N.Y., Aug. 17, 2018 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ : REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on second-year …
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27 November
Regeneron Drops Eylea Combination After Phase 2 Failures

TARRYTOWN, N.Y., Nov. 27, 2017 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that results from two Phase 2 studies that added the angiopoietin2 (Ang2) antibody nesvacumab to EYLEA® (aflibercept) Injection did not provide sufficient differentiation to warrant Phase 3 development. The RUBY study evaluated patients with diabetic macular edema (DME) and the ONYX study …
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25 March
FDA Expands Approval of Regeneron’s Eylea for Diabetic Retinopathy in Patients with Diabetic Macular Edema

The US Food and Drug Administration (FDA) has expanded approval of Regeneron’s macular degeneration drug for treatment of diabetic retinopathy in patients with diabetic macular edema (DME). The agency’s approval of Regeneron Pharmaceuticals’ Eylea (afilibercept) injection for treatment of diabetic retinopathy (DR) in patients with DME marks the fourth approval …
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