EYLEA HD

EYLEA HD is administered intravitreally to exert local effects in the eye. In patients with wet AMD, or DME, following intravitreal administration of EYLEA HD, a fraction of the administered dose is expected to bind with endogenous VEGF in the eye to form an inactive aflibercept: VEGF complex. Once absorbed into the systemic circulation, aflibercept presents in the plasma as free aflibercept (unbound to VEGF) and a more predominant stable inactive form with circulating endogenous VEGF (i.e., afl...

14.1 Neovascular (Wet) Age-Related Macular Degeneration (nAMD) The safety and efficacy of EYLEA HD were assessed in a randomized, multi-center, double-masked, active-controlled study (PULSAR) in treatment-naïve patients with nAMD. A total of 1009 patients were treated and analyzed for efficacy (673 with EYLEA HD). Patients were randomly assigned in a 1:1:1 ratio to 1 of 3 treatment groups: 1) EYLEA HD administered every 12 weeks following 3 initial monthly doses (HDq12); 2) EYLEA HD administered every 16 weeks following 3 initial monthly doses (HDq16); 3) EYLEA 2 mg administered every 8 weeks ...

The following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4.3) ] Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion [see Warnings and Precautions (5.1) ] Increase in intraocular pressure [see Warnings and Precautions (5.2) ] Thromboembolic events [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥3%) reported in patients treated with EYLEA HD were cataract, conju...

Ocular or periocular infection ( 4.1 ) Active intraocular inflammation ( 4.2 ) Hypersensitivity ( 4.3 ) 4.1 Ocular or Periocular Infections EYLEA HD is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation EYLEA HD is contraindicated in patients with active intraocular inflammation. 4.3 Hypersensitivity EYLEA HD is contraindicated in patients with kn...

Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. ( 5.1 ) Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. ( 5.2 ) There is a potential risk of arterial thromboembolic events following intravit...