The FDA has recently made several key decisions impacting the landscape of ophthalmology, including approvals for new treatments and devices, as well as designations to expedite the development of therapies for rare diseases.
Vabysmo Prefilled Syringe Approved
The FDA approved the Vabysmo (faricimab-svoa) 6-mg single-dose prefilled syringe for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). Vabysmo, developed by Roche, is a bispecific antibody that inhibits both VEGF-A and Ang-2, addressing multiple pathways involved in retinal disease. This approval offers a more convenient administration option for patients requiring this therapy.
Aflibercept Biosimilars Approved
In a significant step towards increasing access to retinal disease treatments, the FDA approved Yesafili (aflibercept-yszy) and Opuviz (aflibercept-bvfo) as the first interchangeable biosimilars to Eylea (aflibercept). These biosimilars are approved for the same indications as Eylea, including wet AMD, DME, macular edema following RVO, and diabetic retinopathy. Interchangeability allows pharmacists to substitute the biosimilar for the reference product without the intervention of the prescribing physician, potentially lowering costs and increasing patient access.
Designations for Stargardt Disease Therapy
Gildeuretinol, an investigational oral therapy for the treatment of Stargardt disease, received rare pediatric disease and fast track designations from the FDA. Stargardt disease is an inherited form of macular degeneration that causes progressive vision loss starting in childhood or adolescence. These designations are intended to accelerate the development and review of gildeuretinol, addressing a significant unmet need for patients with this rare condition. The fast track designation facilitates more frequent meetings and communication with the FDA during the drug development process, while the rare pediatric disease designation may qualify the sponsor for a priority review voucher upon approval of the therapy.
Faros Anterior Cataract Surgery System Cleared
The Faros anterior cataract surgery system from Oertli Instrumente received 510(k) clearance from the FDA. This system is designed to facilitate cataract surgery, offering surgeons advanced tools for efficient and precise procedures. The clearance expands the options available to ophthalmologists for performing cataract surgery, a common procedure to restore vision.
