Common ocular adverse reactions (≥2%) and greater than sham in study eye through month 121
Common Adverse Events
IZERVAY (n=292)
Sham (n=332)
Conjunctival hemorrhage 13% 9%
Intraocular pressure (IOP)* 9% 1%
Blurred vision† 8% 5%
Choroidal neovascularization (CNV) 7% 4%
Eye pain 4% 3%
Vitreous floaters 2% <1%
Blepharitis 2% <1%
*Increased intraocular pressure (IOP) was transient.
†Blurred vision includes visual impairment, vision blurred, visual acuity reduced, visual acuity reduced transiently.
Discontinuation rates in the GATHER trials due to adverse events were <2% through 12 months3

Patient retention measured by injection fidelity rates at 12 months12:

Injection fidelity rate is calculated by dividing the total number of administered injections by the total number of expected injections on the number of enrolled patients.
GATHER1
Injection fidelity rate
GATHER2
Injection fidelity rate

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IZERVAY™ IMPORTANT SAFETY INFORMATION AND INDICATION
Contraindications
  • IZERVAY 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 IZERVAY, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering IZERVAY in order 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.
  • Neovascular AMD
    • In clinical trials, use of IZERVAY was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (7% when administered monthly and 4% in the sham group) by Month 12. Patients receiving IZERVAY should be monitored for signs of neovascular AMD.
  • Increase in Intraocular Pressure
    • Transient increases in intraocular pressure (IOP) may occur after any intravitreal injection, including with IZERVAY. Perfusion of the optic nerve head should be monitored following the injection and managed appropriately.
Adverse Reactions
  • Most common adverse reactions (incidence ≥5%) reported in patients receiving IZERVAY were conjunctival hemorrhage, increased IOP, blurred vision, and neovascular age-related macular degeneration.
INDICATION

IZERVAY™ (avacincaptad pegol intravitreal solution) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

Please see full Prescribing Information for more information.