The FDA has granted Fast Track designation to Zimura (avacincaptad pegol; Iveric Bio) for the treatment of geographic atrophy secondary to dry age-related macular degeneration.
The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for abicipar pegol (Allergan), an investigational DARPin (designed ankyrin repeat proteins) therapy, in patients with neovascular (wet) age-related macular degeneration (nAMD). Abicipar pegol is comprised of DARPin molecules, which are part of a new investigational class of binding protein. It works by…
The FDA has approved Eylea (aflibercept; Regeneron) injection in a prefilled syringe formulation. Prior to the approval, Eylea had only been available in 2mg single-dose vials.
Clearside Biomedical announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Xipere (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection for the treatment of macular edema associated with uveitis.
The 0.3mg PFS marks the first approved syringe with an anti-vascular endothelial growth factor (VEGF) to treat all forms of diabetic retinopathy with or without diabetic macular edema (DME).
