SYFOVRE

SYFOVRE is administered directly into the vitreous to exert local effects in the eye. Following repeat intravitreal administration of pegcetacoplan at a dose of 15 mg, geometric mean (%CV) serum C max value at steady state was 2.2 μg/mL (28.7%) and 1.5 μg/mL (58.1%) for GA patients dosed monthly and every other month, respectively. The steady state geometric mean (%CV) serum trough concentrations were 1.0 μg/mL (52.3%) and 0.2 μg/mL (89.6%) for patients treated monthly and every other month, res...

The safety and efficacy of SYFOVRE were assessed in two multi-center, randomized, sham-controlled studies in patients with GA (atrophic nonexudative age-related macular degeneration), with or without subfoveal involvement, secondary to AMD in a total of 1258 randomized patients (SYFOVRE 839 patients, sham 419 patients). Studies OAKS (APL2-304; NCT03525613) and DERBY (APL2-303; NCT03525600) were 24 months in duration, in which patients received treatment for the entire length of the study. Patient ages ranged from 60 to 100 years with a mean of 78.7 years. Mean (standard deviation) total area o...

The following clinically significant adverse reactions are described elsewhere in the labeling: Ocular and periocular infections [see Contraindications (4.1) ] Active intraocular inflammation [see Contraindications (4.2) ] Hypersensitivity [see Contraindications (4.3) ] Endophthalmitis and retinal detachments [see Warnings and Precautions (5.1) ] Retinal Vasculitis and/or Retinal Vascular Occlusion [see Warnings and Precautions (5.2) ] Neovascular AMD [see Warnings and Precautions (5.3) ] Intrao...

Ocular or Periocular Infections ( 4.1 ) Active Intraocular Inflammation ( 4.2 ) Hypersensitivity ( 4.3 ) 4.1 Ocular or Periocular Infections SYFOVRE is contraindicated in patients with ocular or periocular infections [see Warnings and Precautions (5.1) ] . 4.2 Active Intraocular Inflammation SYFOVRE is contraindicated in patients with active intraocular inflammation. 4.3 Hypersensitivity SYFOVRE i...

Endophthalmitis and Retinal Detachments ( 5.1 ) Retinal Vasculitis and/or Retinal Vascular Occlusion ( 5.2 ) Neovascular AMD ( 5.3 ) Intraocular inflammation ( 5.4 ) Increased Intraocular Pressure ( 5.5 ) 5.1 Endophthalmitis and Retinal Detachments Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments [see Adverse Reactions (6.1) ] . Proper aseptic injection technique must always be used when administering SYFOVRE in order to minimi...