Eylea's Dosing Regimen Is Key Question As FDA Takes Draft Labeling To Advisory Committee
This article was originally published in The Pink Sheet Daily
Advisory panel to consider a bi-monthly dosing scheme for Regeneron's wet AMD and how to handle potential elevations in intraocular pressure at June 17 meeting.
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Regneron and Bayer likely to tout aflibercept's better dosing schedule over Lucentis and may seek further differentiation in wake of Lucentis v. Avastin study.
The efficacy of low-cost Avastin and pricier Lucentis for the treatment of wet-AMD are similar in the first head-to-head clinical trial to compare the two drugs, though Novartis and Genentech call out safety uncertainties.
Positive results of two Phase III studies show VEGF Trap-Eye candidate has potential for dosing every two months, but competing against Roche's Lucentis and off-label Avastin won't be easy.