Macular Edema Following Retinal Vein Occlusion

• FDA approval · 2026-04-02
  FDA Approved: EYLEA HD — Supplemental Application (Regeneron Pharmaceuticals, Inc)

  FDA approved a supplemental application for EYLEA HD, a high-dose formulation of aflibercept, expanding the product's labeling.

• FDA approval · 2026-03-11
  FDA Approved: OZURDEX — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for OZURDEX (dexamethasone intravitreal implant) submitted by Allergan, Inc.

• FDA approval · 2025-08-15
  FDA Approved: BYOOVIZ — Supplemental Application (BIOGEN INC.)

  FDA approved a supplemental application for BYOOVIZ (ranibizumab-nuna) from Biogen, updating its labeling with additional indications for oc…

• FDA approval · 2024-10-10
  FDA Approved: EYLEA HD — Supplemental Application (Regeneron Pharmaceuticals, Inc)

  The FDA approved a supplemental application for EYLEA HD (aflibercept) from Regeneron, enabling use of the high-dose formulation for treatin…

• 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…

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• 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.

• 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 · 2021-10-22
  FDA Approved: XIPERE — Original Application (Bausch & Lomb Incorporated)

  FDA approved XIPERE (triamcinolone acetonide) through an original application for the treatment of macular edema following retinal vein occl…

• 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 · 2016-02-05
  FDA Approved: OZURDEX — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for Ozurdex (dexamethasone) by Allergan, authorizing an expanded indication for the product.

• 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…