Opuviz FDA Approval History
Last updated by Judith Stewart, BPharm on May 21, 2024.
FDA Approved: Yes (First approved May 20, 2024)
Brand name: Opuviz
Generic name: aflibercept-yszy
Dosage form: Injection
Company: Samsung Bioepis Co., Ltd.
Treatment for: Macular Degeneration, Macular Edema Following Retinal Vein Occlusion, Diabetic Macular Edema, Diabetic Retinopathy
Opuviz (aflibercept-yszy) is a vascular endothelial growth factor (VEGF) inhibitor interchangeable biosimilar to Eylea indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
- Unlike Eylea (aflibercept), Opuviz is not indicated for the treatment of patients with retinopathy of prematurity.
- Opuviz is biosimilar to Eylea and has an interchangeability designation.
- Opuviz is administered by intravitreal injection.
- FDA approval of Opuviz was based on a comprehensive review of scientific evidence that demonstrated the product is highly similar to Eylea, and that there were no clinically meaningful differences from Eylea.
- Warnings and precautions associated with Opuviz include endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion; increases in intraocular pressure; and risk of arterial thromboembolic events.
- Common adverse reactions include conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.
- Opuviz (aflibercept-yszy) and Yesafili (aflibercept-jbvf) are the first FDA-approved Eylea biosimilars, both approved on May 20, 2024.
Development timeline for Opuviz
| Date | Article |
|---|---|
| May 20, 2024 | Approval FDA Approves Opuviz (aflibercept-yszy), an Interchangeable Biosimilar to Eylea |
Further information
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