December 27, 2024
1 min read
Healio’s top FDA articles in ophthalmology this year included updates on the Vabsymo prefilled syringe, two new aflibercept biosimilars and an oral therapy for Stargardt disease.
Check out 2024’s top FDA news below.
FDA clears Faros anterior cataract surgery system
The FDA granted 510(k) clearance to the Faros anterior cataract surgery system from Oertli Instrumente. Read more.
FDA approves Vabysmo prefilled syringe for retinal diseases
The FDA approved the Vabysmo 6-mg single-dose prefilled syringe for the treatment of wet age-related macular degeneration, diabetic macular edema and macular edema following retinal vein occlusion. Read more.
FDA approves aflibercept biosimilars Yesafili, Opuviz
The FDA approved Yesafili and Opuviz as the first interchangeable biosimilars to Eylea. Read more.
FDA grants rare pediatric disease, fast track designations to Stargardt disease therapy
The FDA granted rare pediatric disease and fast track designations to gildeuretinol, an investigational oral therapy for the treatment of Stargardt disease. Read more.
FDA grants de novo classification to Fysx ocular pressure adjusting pump
The FDA granted de novo classification to the Fysx ocular pressure adjusting pump for patients with normal-tension glaucoma or open-angle glaucoma with IOP of 21 mm Hg or less. Read more.
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