Allergan and Molecular Partners Report Acceptance of FDA’s BLA and Validation of EMA’s MAA for Abicipar Pegol

Allergan Reports FDA’s Acceptance of NDA for Bimatoprost Sustained-Release to Treat Glaucoma or Ocular Hypertension

Shots:

  • The BLA and MAA are based on P-III CEDAR and SEQUOIA studies assessing Abicipar (quarterly dosing regimen) vs ranibizumab in patients with neovascular (wet) age-related macular degeneration resulting in maintaining vision gains with 6/8 vs 13 injection @52wks. with its expected approval in H2’2020 in the US & EU
  • The acceptance of the FDA’s BLA is an important milestone for the Molecular’s DARPin technology as Abicipar is the first DARPin candidate to receive the FDA’s acceptance
  • DARPin molecules are genetically engineered Ab mimetic protein, exhibiting high-affinity target protein binding, derived from natural ankyrin protein and are being evaluated for ophthalmology, oncology and immuno-oncology

Click here to­ read full press release/ article | Ref: Allergan | Image: WSJ