FDA news: Top stories in ophthalmology
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Catch up on Healio’s top stories on the latest FDA news in ophthalmology.
Topics include the approval of an Eylea biosimilar, clearance of Alcon’s Unity cataract and vitreoretinal cataract systems and more.
FDA approves Vabysmo prefilled syringe for retinal diseases
The prefilled syringe is indicated for wet age-related macular degeneration, diabetic macular edema and retinal vein occlusion. Read more.
FDA approves Eylea biosimilar FYB203/Ahzantive
FYB203/Ahzantive (aflibercept-mrbb) was approved for the treatment of neovascular age-related macular degeneration, diabetic macular edema, diabetic retinopathy and macular edema following retinal vein occlusion. Read more.
FDA grants de novo classification to Fysx ocular pressure adjusting pump
The device features a portable pump as well as pressure-sensing googles that are worn at night, when IOP typically increases. It is indicated in patients who are using or have undergone another IOP-lowering treatment. Read more.
FDA clears Alcon’s Unity cataract system, Unity vitreoretinal cataract system
The company said the systems provide workflow efficiencies over its current Constellation vision system for vitreoretinal surgery and Centurian vision system for cataract surgery. Read more.
FDA grants priority review of NT-501 for macular telangiectasia type 2
The ocular implant is designed to deliver sustained therapeutic doses of ciliary neurotrophic factor to the retina. Read more.
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