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Xipere FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 26, 2021.

FDA Approved: Yes (First approved October 22, 2021)
Brand name: Xipere
Generic name: triamcinolone acetonide
Dosage form: Injection
Company: Clearside Biomedical, Inc.
Treatment for: Macular Edema, Uveitis

Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use is a corticosteroid indicated for the treatment of macular edema associated with uveitis.

  • Corticosteroids such as triamcinolone acetonide are the standard of care in uveitis and are effective at treating the inflammatory aspect of ocular disease. Approximately one-third of uveitis patients develop uveitic macular edema, a build-up of fluid in the macula which causes retinal swelling and distorted vision, and may lead to permanent vision loss.
  • Xipere is administered via the SCS Microinjector® to provide targeted delivery into the suprachoroidal space in the back of the eye. Targeted delivery means the drug has the potential to act for a longer period of time, while minimizing harm to the surrounding healthy parts of the eye.
  • Common adverse reactions include elevated intraocular pressure and eye pain.

Development Timeline for Xipere

DateArticle
Oct 25, 2021Approval  FDA Approves Xipere (triamcinolone acetonide injectable suspension) for the Treatment of Macular Edema Associated with Uveitis
May  3, 2021Clearside Biomedical Announces Resubmission of New Drug Application for Xipere for Treatment of Macular Edema Associated with Uveitis
Aug 22, 2019Clearside Biomedical Provides New Drug Application Update for Xipere (triamcinolone acetonide suprachoroidal injectable suspension)
Dec 19, 2018Clearside Biomedical Submits New Drug Application for Xipere for the Treatment of Macular Edema Associated with Uveitis

Further information

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