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 ...

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 ...

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 ...

Background To investigate the short-term outcomes of treatment with intravitreal aflibercept in cases with wet age-related macular degeneration (AMD) resistant to ranibizumab. Methods The study ...

The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application (sBLA) for Eylea HD (aflibercept) injection 8mg for priority review.

Further information Decision makers noted that Aflibercept 8mg is clinically equivalent and of at least equal cost-effectiveness to the NICE recommended aflibercept 2mg formulation (TA 346 and TA294).

One trial evaluated sozinibercept in combination with aflibercept 2 mg (Eylea), the other in combination with ranibizumab 0.5 mg (Lucentis). The comparator in both trials was aflibercept or ...

The primary endpoint was the mean change in best corrected visual acuity at 52 weeks. Aflibercept monotherapy demonstrated better BCVA change vs. sozinibercept combination therapy. Editor’s note ...

UBX1325 did not meet statistical noninferiority to aflibercept on the average of weeks 20 and 24. Patients treated with UBX1325 had vision gains comparable to aflibercept at weeks 24 and 36.