Diabetic Macular Edema

• FDA approval · 2023-12-14
  FDA Approved: EYLEA — Supplemental Application (Regeneron Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for EYLEA (aflibercept) from Regeneron Pharmaceuticals, Inc.

• FDA approval · 2023-10-26
  FDA Approved: VABYSMO — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for VABYSMO (faricimab) by Genentech, expanding its labeling/indication via supplemental approval.

• FDA approval · 2023-10-03
  FDA Approved: BYOOVIZ — Supplemental Application (BIOGEN INC.)

  FDA approved Biogen's BYOOVIZ (ranibizumab-nuna) via a supplemental application, providing an additional approval for this ranibizumab biosi…

• FDA approval · 2023-08-18
  FDA Approved: EYLEA HD — Original Application (Regeneron Pharmaceuticals, Inc)

  FDA approved a high-dose formulation of EYLEA (aflibercept) under a new original application for its retinal disease indications.

• FDA approval · 2023-06-16
  FDA Approved: BYOOVIZ — Supplemental Application (BIOGEN INC.)

  FDA approved a supplemental application for BYOOVIZ (ranibizumab-nuna) from Biogen Inc.

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• FDA approval · 2023-01-27
  FDA Approved: VABYSMO — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for VABYSMO (faricimab) from Genentech, Inc., regarding an updated indication or labeling. This …

• FDA approval · 2022-12-19
  FDA Approved: OZURDEX — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for OZURDEX (dexamethasone intravitreal implant) from Allergan, Inc., resulting in labeling chan…

• FDA approval · 2022-08-15
  FDA Approved: BYOOVIZ — Supplemental Application (BIOGEN INC.)

  FDA approves Biogen's BYOOVIZ (ranibizumab-nuna) via a supplemental application, authorizing the biosimilar for the same ocular indications …

• FDA approval · 2022-08-02
  FDA Approved: CIMERLI — Original Application (Coherus BioSciences Inc)

  FDA approved CIMERLI (ranibizumab-eqrn) from Coherus as an original Biologics License Application. It is a biosimilar to ranibizumab (Lucent…

• FDA approval · 2022-06-09
  FDA Approved: BYOOVIZ — Supplemental Application (BIOGEN INC.)

  The FDA approved a supplemental application for BYOOVIZ (ranibizumab-nuna) from Biogen, authorizing its use as a biosimilar to ranibizumab.

• FDA approval · 2022-01-28
  FDA Approved: VABYSMO — Original Application (Genentech, Inc.)

  FDA approves VABYSMO (faricimab) for the treatment of neovascular age-related macular degeneration and diabetic macular edema under the orig…

• FDA approval · 2021-09-17
  FDA Approved: BYOOVIZ — Original Application (BIOGEN INC.)

  BYOOVIZ, Biogen's ranibizumab-nuna biosimilar, has been approved by the FDA through its Original Application, with indications matching thos…

• FDA approval · 2019-08-12
  FDA Approved: EYLEA — Supplemental Application (Regeneron Pharmaceuticals, Inc.)

  The FDA approved Regeneron's supplemental application for EYLEA (aflibercept), updating its labeling to reflect an expanded or modified indi…

• FDA approval · 2018-08-16
  FDA Approved: EYLEA — Supplemental Application (Regeneron Pharmaceuticals, Inc.)

  FDA has approved a supplemental application for EYLEA (aflibercept) from Regeneron Pharmaceuticals, Inc. The approval indicates the suppleme…

• FDA approval · 2017-05-26
  FDA Approved: EYLEA — Supplemental Application (Regeneron Pharmaceuticals, Inc.)

  FDA approved a supplemental application for EYLEA (aflibercept) submitted by Regeneron Pharmaceuticals, Inc. The action updates labeling and…

• FDA approval · 2017-03-08
  FDA Approved: ILUVIEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for ILUVIEN (fluocinolone acetonide) submitted by ANI Pharmaceuticals, Inc.

• FDA approval · 2017-01-05
  FDA Approved: LUCENTIS — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for LUCENTIS (ranibizumab) from Genentech, Inc., modifying the existing approval.

• FDA approval · 2015-05-18
  FDA Approved: ILUVIEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application from ANI Pharmaceuticals to add a new manufacturer for ILUVIEN (fluocinolone acetonide) under the ex…

• FDA approval · 2014-09-26
  FDA Approved: ILUVIEN — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved the original application for ILUVIEN (fluocinolone acetonide) intravitreal implant by ANI Pharmaceuticals for the treatment…

• FDA approval · 2012-02-24
  FDA Approved: OZURDEX — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for OZURDEX (dexamethasone) from Allergan, Inc.

• FDA approval · 2011-11-18
  FDA Approved: EYLEA — Original Application (Regeneron Pharmaceuticals, Inc.)

  The FDA approved EYLEA (aflibercept) through its original application, establishing its initial indications for retinal diseases including a…