Bayer Plans Two P-III Studies to Evaluate Aflibercept 8mg Formulation

Bayer Plans Two P-III Studies to Evaluate Aflibercept 8mg Formulation

Shots:

  • The two P-III studies, PHOTON and PULSAR will assess aflibercept 8mg formulation for intravitreal injection in adults with visual impairment due to DME & wet AMD respectively for 12wks with their expected initiation in 2020
  • In 2006, the companies collaborated for aflibercept, under which Regeneron retains rights to Eylea (aflibercept, 2mg) in the US while Bayer has exclusive commercial right outside the US with 50/50 profit sharing, except for Japan where Regeneron received a percentage of total sales
  • Aflibercept solution for injection is a recombinant fusion protein, consisting of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for IVT

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