FDA roundup: Recent news in ophthalmology
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Healio’s recent FDA news in ophthalmology includes the approval of Enzeevu for neovascular age-related macular degeneration and a rare pediatric disease designation for an X-linked retinoschisis candidate.
Catch up on these stories and more below.
FDA approves Enzeevu, aflibercept biosimilar for neovascular AMD
The FDA approved the Enzeevu 2 mg vial kit and prefilled syringe for intravitreal injection for the treatment of neovascular age-related macular degeneration. Read more.
Gene therapy for X-linked retinoschisis receives rare pediatric disease designation
The FDA granted rare pediatric disease designation to ATSN-201, a gene therapy candidate for the treatment of X-linked retinoschisis. Read more.
Ocular Therapeutix receives FDA nod for SOL-R registrational study of Axpaxli
Ocular Therapeutix obtained FDA support to use the phase 3 SOL-R trial as the next step in the regulatory process for Axpaxli. Read more.
FDA approves expanded access program for retinitis pigmentosa gene therapy candidate
The FDA approved Ocugen’s expanded access program for the treatment of retinitis pigmentosa with OCU400. Read more.
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.
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