On Aug. 4, 2023, the U.S. Food and Drug Administration (FDA) approved Iveric Bio’s Izervay™ (avacincaptad pegol intravitreal solution), a complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). In a sterile setting, a specialized eye care professional injects it into the back of each affected eye. Treatments are administered once monthly at a dose of 2mg (0.1mL) per eye for up to 12 months. The launch is expected within two to four weeks. Pricing information is not yet available. For full prescribing information, look here.
At a Glance
- Brand (Generic) Name: Izervay (avacincaptad pegol intravitreal solution)
- Manufacturer: Iveric Bio, an Astellas Company
- Date Approved: Aug. 4, 2023
- Indication: to treat GA secondary to AMD
- Dosage Forms Available: single-dose vials containing 20mg/mL
- Launch Date: within two to four weeks
- Estimated Annual Cost: Pricing information is not yet available.
- The worldwide prevalence of GA is believed to be 4% for patients up to about 85 years old, but then it jumps to roughly 22% at age 90. Approximately 1.5 million Americans are estimated to have GA; however, about three-quarters of those patients are undiagnosed.
- GA causes lesions on the retinas, which result in permanent pigment loss in central areas of vision – typically in both eyes. As many as two-thirds of untreated patients may become blind or severely visually impaired.
- Izervay blocks an immune system protein, complement C5, to interfere with the progression of GA. It does not restore lost vision, however.
- In two phase III clinical trials, Izervay reduced disease progression by 35% at one year compared to placebo injections.
- The most common adverse effects in the studies included conjunctival hemorrhage, increased intraocular pressure (IOP), blurred vision, and neovascular (wet) AMD.
- Apellis Pharmaceuticals’ Syfovre™ (pegcetacoplan intravitreal solution) is a complement C3 inhibitor that was approved on Feb. 17, 2023, for the treatment of GA secondary to AMD.
- Izervay was designated as a Breakthrough Therapy and given Priority Review.