According to the letter, the FDA did not agree with the proposition to include additional extended dosing intervals greater than 16 weeks. The Food and Drug Administration (FDA) has issued a ...

An FDA target action date of August 19, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License ...

High-dose aflibercept offers extended dosing intervals for DME and wet AMD, with sustained visual and anatomical improvements. The PULSAR and PHOTON trials showed efficacy in maintaining vision ...

Back to Healio 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. Gill, vice chair of ...

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 ...

EYLEA HD® (aflibercept) Injection 8 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and ...