Age-related Macular Degeneration

• FDA approval · 2026-02-27
  FDA Approved: IZERVAY — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for IZERVAY (avacincaptad pegol) from Astellas Pharma US, expanding its label for geographic atr…

• FDA approval · 2025-11-19
  FDA Approved: EYLEA HD — Supplemental Application (Regeneron Pharmaceuticals, Inc)

  The FDA approved a supplemental application for EYLEA HD (aflibercept) by Regeneron, introducing a high-dose formulation.

• FDA approval · 2025-11-12
  FDA Approved: BYOOVIZ — Supplemental Application (BIOGEN INC.)

  The FDA approved a supplemental Biologics License Application for BYOOVIZ (ranibizumab-nuna) from Biogen, expanding regulatory clearance for…

• FDA approval · 2025-02-12
  FDA Approved: IZERVAY — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for IZERVAY (avacincaptad pegol) submitted by Astellas Pharma US, Inc.

• FDA approval · 2024-07-29
  FDA Approved: BEOVU — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

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• FDA approval · 2023-09-28
  FDA Approved: BEOVU — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for BEOVU (brolucizumab) from Novartis, indicating a regulatory action that may involve labeling upd…

• 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 · 2023-02-17
  FDA Approved: SYFOVRE — Original Application (Apellis Pharmaceuticals, Inc.)

  FDA approved SYFOVRE (pegcetacoplan) from Apellis Pharmaceuticals for geographic atrophy associated with age-related macular degeneration, m…

• 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 · 2021-07-09
  FDA Approved: VISUDYNE — Supplemental Application (Bausch & Lomb Incorporated)

  The FDA approved a supplemental application for VISUDYNE (verteporfin for injection) from Bausch & Lomb Incorporated, updating the product a…

• EMA approval · 2020-09-16
  EMA Authorised: Visudyne (verteporfin) — CHEPLAPHARM Arzneimittel GmbH

  EMA confirms authorisation of Visudyne (verteporfin) by CHEPLAPHARM Arzneimittel GmbH for indications related to degenerative myopia and mac…

• 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 · 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 · 2016-05-11
  FDA Approved: VISUDYNE — Supplemental Application (Bausch & Lomb Incorporated)

  The FDA approved a supplemental application for VISUDYNE (verteporfin for injection) from Bausch & Lomb Incorporated.

• FDA approval · 2014-05-06
  FDA Approved: VISUDYNE — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for VISUDYNE (verteporfin for injection) filed by Bausch & Lomb Incorporated.

• FDA approval · 2013-10-08
  FDA Approved: VISUDYNE — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for Visudyne (verteporfin for injection) filed by Bausch & Lomb Incorporated.

• FDA approval · 2012-06-28
  FDA Approved: VISUDYNE — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for VISUDYNE (verteporfin for injection) submitted by Bausch & Lomb Incorporated. The action updates…

• 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…