The Burden of Geographic Atrophy

Geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD), currently affects approximately 5 million people around the world,³ including about 1 million people in the United States.^3,4 Worldwide, AMD is a leading cause of blindness in the elderly,⁵ and GA accounts for 20% of all legal blindness due to AMD.^6,7 In the United States, the prevalence of GA will continue to increase⁸: from age 50, the prevalence of GA quadruples every 10 years,⁹ and the number of people in the United States over age 60 will double between 2015 and 2050.

GA progresses relentlessly and can cause permanent vision loss. Clinical variables like best-corrected visual acuity (BCVA) give an incomplete picture of how GA affects patients, because visual impairment occurs before GA reaches the fovea. From a subpopulation of a retrospective analysis of 397 patients within the larger prospective Age-Related Eye Disease Study (AREDS) of 3,640 patients, for patients who developed central GA, the median time to development was just 2.5 years.¹⁰

For affected individuals, GA causes the progressive loss of functional vision. They have difficulty driving at night and performing a host of tasks and activities that were once part of their daily lives. These changes can happen rapidly: a majority of those diagnosed with GA will lose substantial vision within 2 to 3 years.

—Roger A. Goldberg, MD, MBA

INDICATION

SYFOVRE® (pegcetacoplan injection) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

• SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation

WARNINGS AND PRECAUTIONS

• Endophthalmitis and Retinal Detachments
  • Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.
• Retinal Vasculitis and/or Retinal Vascular Occlusion
  • Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE. Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without delay.
• Neovascular AMD
  • In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration.
• Intraocular Inflammation
  • In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE.
• Increased Intraocular Pressure
  • Acute increase in IOP may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed.

ADVERSE REACTIONS

• Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage.

Please see full Prescribing Information for more information.