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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