Geographic atrophy secondary to age-related macular degeneration
15 mg (0.1 mL of 150 mg/mL) intravitreally into each affected eye every 25 to 60 days
Slows lesion growth without restoring acuity, and raises the risk of converting to neovascular AMD
Contraindications
Ocular or Periocular Infections Active Intraocular Inflammation Hypersensitivity.
Available Forms
Single-dose glass vial containing an overfill to allow a single 0.1 mL dose of 150 mg/mL solution.
Mechanism of Action
Pegcetacoplan binds to complement protein C3 and its activation fragment C3b with high affinity thereby regulating the cleavage of C3 and the generation of downstream effectors of complement activation.
Warnings & Precautions
Endophthalmitis and retinal detachment may follow intravitreal injection. Retinal vasculitis and retinal vascular occlusion have been reported, typically within the first week after the first dose. Treatment increases the risk of neovascular AMD in the treated eye. Intraocular inflammation and increased intraocular pressure have been reported.
Common Side Effects
The most common adverse reactions (≥5%) reported in patients receiving SYFOVRE were ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, and conjunctival hemorrhage.
Pregnancy & Lactation
Pregnancy: No adequate and well-controlled studies in pregnant women to inform a drug-associated risk; use may be considered after weighing risks and benefits.
Lactation: No data on presence in human milk or effects on the breastfed infant.
Pediatric Use
The safety and effectiveness of SYFOVRE in pediatric patients have not been established.