Patients with DME who are treated using aflibercept are more likely to experience acute kidney injury or hospitalisation due to renal events than those treated with ranibizumab. Using a target trial ...

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 ...

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 Application ...

Regeneron aims for FDA approval of extended dosing for EYLEA HD in AMD and DME, with a decision by April 2025. Pre-filled syringes of high-dose aflibercept are expected to launch by mid-2025, pending ...

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Regeneron regarding the supplemental Biologics License Application (sBLA) for aflibercept 8mg injection for the ...

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 ...

The FDA issued a complete response letter to Regeneron, disagreeing with extending aflibercept 8 mg dosing intervals beyond 16 weeks. Aflibercept 8 mg is approved for wet AMD, DME, and DR with ...