Dry Eye Disease

• EMA approval · 2026-01-15
  EMA Authorised: Ikervis (ciclosporin) — Santen Oy

  The EMA authorised Ikervis (ciclosporin) for corneal diseases. The marketing authorization holder is Santen Oy, with a decision date of 27 F…

• FDA approval · 2025-09-18
  FDA Approved: VEVYE — Supplemental Application (Harrow Eye, LLC)

  The FDA approved a supplemental NDA for VEVYE (cyclosporine ophthalmic solution) submitted by Harrow Eye, LLC.

• FDA approval · 2024-05-28
  FDA Approved: VEVYE — Supplemental Application (Harrow Eye, LLC)

  FDA approved a supplemental application for VEVYE (cyclosporine ophthalmic solution) from Harrow Eye, LLC. The approval pertains to the opht…

• FDA approval · 2024-04-04
  FDA Approved: XIIDRA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for XIIDRA (lifitegrast) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2024-02-02
  FDA Approved: TYRVAYA — Supplemental Application (Oyster Point Pharma, Inc.)

  FDA approved a supplemental application for TYRVAYA (varenicline) from Oyster Point Pharma, expanding the regulatory approval.

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• FDA approval · 2023-11-07
  FDA Approved: LIFITEGRAST — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original ANDA for Lifitegrast, a generic treatment for dry eye disease.

• FDA approval · 2023-05-30
  FDA Approved: VEVYE — Original Application (Harrow Eye, LLC)

  FDA approved VEVYE, a cyclosporine ophthalmic solution, from Harrow Eye, LLC, through its original NDA. It is indicated for the treatment of…

• FDA approval · 2020-06-04
  FDA Approved: XIIDRA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Xiidra (lifitegrast) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2018-08-14
  FDA Approved: CEQUA — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved CEQUA (cyclosporine ophthalmic solution) from Sun Pharmaceutical Industries as an original NDA for the treatment of dry eye dis…

• FDA approval · 2017-12-17
  FDA Approved: XIIDRA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for XIIDRA (lifitegrast) by Novartis Pharmaceuticals Corporation.

• FDA approval · 2016-07-11
  FDA Approved: XIIDRA — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approved XIIDRA (lifitegrast) via an original NDA for the treatment of dry eye disease. The product is manufactured by Novartis Pharmace…

• FDA approval · 2008-02-21
  FDA Approved: LACRISERT — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for LACRISERT (hydroxypropyl cellulose) from Bausch & Lomb Incorporated.