Neovascular Age-related Macular Degeneration

• EMA approval · 2026-07-24
  New treatment option for neovascular age-related macular degeneration

  EMA announces Susvimo as a new treatment option for neovascular age-related macular degeneration, delivered via an ocular implant to reduce …

• 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 · 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 · 2025-05-21
  FDA Approved: SUSVIMO — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for SUSVIMO (ranibizumab) from Genentech, expanding the regulatory approval for this port delive…

• 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…

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• FDA approval · 2024-07-03
  FDA Approved: VABYSMO — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for VABYSMO (faricimab) submitted by Genentech, Inc., indicating an update to the product labeling o…

• 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 · 2023-01-27
  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: BEOVU — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for BEOVU (brolucizumab) from Novartis Pharmaceuticals Corporation. This action approves an expa…

• 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 · 2022-06-09
  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 · 2022-04-18
  FDA Approved: SUSVIMO — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for SUSVIMO, Genentech's port delivery system for ranibizumab, expanding its use for the treatme…

• FDA approval · 2022-03-09
  FDA Approved: BEOVU — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for BEOVU (brolucizumab) from Novartis Pharmaceuticals Corporation, resulting in an updated labe…

• 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 · 2020-06-09
  FDA Approved: BEOVU — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for BEOVU (brolucizumab) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2019-10-07
  FDA Approved: BEOVU — Original Application (Novartis Pharmaceuticals Corporation)

  The FDA approved BEOVU (brolucizumab) under an original application from Novartis Pharmaceuticals Corporation for the treatment of neovascul…

• 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.