News

The American Journal of Managed Care1d
FDA Delivers CRL for Longer Dosage Intervals in Aflibercept for DME, Wet AMD
The complete response letter (CRL) specifies that the current dosage duration of aflibercept is still safe but extending the ...
Ophthalmology Times1d
Regeneron announces FDA issues CRL for aflibercept 8 mg (Eylea HD) sBLA
The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up ...
MPR1d
FDA Denies Approval of Additional Extended Dosing Intervals for High Dose Aflibercept
After 3 initial monthly injections, current dosing intervals range from every 8 to 16 weeks in patients with wAMD and DME and every 8 to 12 weeks in patients with DR.
Ophthalmology Times12d
EMA application filed by Bayer to expand aflibercept 8 mg indication to include retinal vein occlusion
In the European Union and United Kingdom, aflibercept 8 mg (Eylea HD in the US) is currently approved for neovascular ...
PharmExec4d
FDA Grants Priority Review to Regeneron’s Eylea for Macular Edema Following Retinal Vein Occlusion
Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks ...
Seeking Alpha5d
EYLEA HD® (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority Review for Both the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly ...
If approved, EYLEA HD would be the first and only treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period – halving the number of injections that are ...