Xipere for Suprachoroidal Use Approved for Macular Edema Associated With Uveitis
The approval was based on data from the pivotal phase 3 PEACHTREE trial, the phase 3 MAGNOLIA study, and the open-label safety AZALEA trial.
Macular Edema
First Biosimilar to Lucentis Gets FDA Approval
The approval of Byooviz was based on a review of evidence demonstrating a high degree of similarity to the reference product.
Faricimab Gets Priority Review for Wet AMD, Diabetic Macular Edema
The BLA submission is based on positive results across four phase 3 studies in wet AMD and DME.
Aflibercept Cuts Vision-Threatening Complications of Diabetic Retinopathy
But no improvement in visual acuity seen with aflibercept versus sham for eyes with nonproliferative diabetic retinopathy
Zimura Gets Fast Track Status for Geographic Atrophy Secondary to Dry AMD
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.
FDA Accepts BLA for Abicipar Pegol for Neovascular 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…
Prefilled Syringe Formulation of Eylea Gets FDA Approval
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.
Xipere Under FDA Review for Macular Edema Associated With Uveitis
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.
Additional Strength of Lucentis Prefilled Syringe FDA-Approved
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).
