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EYLEA HD was developed to achieve comparable efficacy and safety to EYLEA, but with fewer injections. EYLEA HD is supported by a robust body of research and is currently approved in the U.S. to ...
The FDA issued a complete response letter for a supplemental biologics license application, in which it did not approve ...
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, reducing the number of injections by half ...
Similar to Vabysmo, it is also available in both vials and prefilled syringes, and administered via intravitreal injection. Eylea, along with a higher-dose version at 8mg, generated global sales ...
Pharmaceuticals announced on Friday the Food and Drug Administration has issued a complete response letter regarding the ...
The FDA issued a complete response letter for a supplemental biologics license application, in which it did not approve extending the dosing intervals for Eylea HD, according to a press release ...
EYLEA HD seeks to halve the number of injections compared to current anti-VEGF therapies for RVO, which are indicated for monthly dosing. The FDA target action date for a decision on EYLEA HD is ...
EYLEA HD was developed to achieve comparable efficacy and safety to EYLEA, but with fewer injections. EYLEA HD is supported by a robust body of research and is currently approved in the U.S. to treat ...