The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept injection 8mg for the treatment of macular edema following ...

The complete response letter (CRL) specifies that the current dosage duration of aflibercept is still safe but extending the ...

The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up ...

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.

In this expert perspective, Manjot K. Gill, MD, discusses the potential FDA approval in 2025 of aflibercept 8 mg for the treatment of retinal vein occlusion.

In the European Union and United Kingdom, aflibercept 8 mg (Eylea HD in the US) is currently approved for neovascular ...

Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks ...

Patients with diabetic macular edema treated with intravitreal aflibercept have a significantly higher risk of adverse renal events compared with those treated with ranibizumab.

EYLEA ® (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion ...

SOUTH SAN FRANCISCO, Calif., April 22, 2025 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (UNITY) [NASDAQ:UBX], a ...

for EYLEA HD ® (aflibercept) Injection 8 mg across all approved indications. The CRL did not identify any issues with the safety or efficacy of EYLEA HD in its approved indications and dosing ...