Thursday, June 14, 2012

Fovista ushers in good news for Wet AMD patients - Regeneron, Santen, Bayer stock may be impacted

In a prospective, randomized, controlled Phase 2b clinical trial of 449 patients with wet AMD, Ophthotech’s FovistaTM anti-PDGF therapy (1.5 mg), administered in combination with Lucentis anti-VEGF therapy, met the pre-specified primary efficacy endpoint of mean vision gain. Patients receiving the combination of Fovista (1.5 mg) and Lucentis gained a mean of 10.6 letters of vision on the ETDRS standardized chart at 24 weeks, compared to 6.5 letters for patients receiving Lucentis monotherapy (p=0.019), representing a 62% additional benefits, which represents a paradigm shift in the treatment of wet AMD. 

Fovista once approved would give a boost to Lucentis sales, which have been otherwise impacted becasue of Eylea launch.  The shares of Regeneron were down 12%, as it may impact Eylea sales once approved. Although Fovista may work as well in combination with Eylea, as observed with Lucentis, but in absence of clinical trials, it is unlikely that physicians would prefer to use it otherwise. Santen which has copromotion rights with Bayer for Eylea in Japan may also be impacted because of this development.

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