Common ocular adverse reactions (≥2%) and greater than sham in study eye through month 121
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%
*Blurred vision includes visual impairment, vision blurred, visual acuity reduced, visual acuity reduced transiently.
No reported cases of permanent vision loss due to AEs in the 12-month GATHER clinical trials
Adverse events of special interest3
GATHER1 IZERVAY (n=67)
GATHER1 Sham (n=110)
GATHER2 IZERVAY (n=225)
GATHER2 Sham (n=222)
Intraocular inflammation (IOI), n† 1 0 0 0
Endophthalmitis, n 0 0 0 0
Ischemic optic neuropathy, n 0 0 0 0
Retinal vasculitis, n 0 0 0 0
†A single case of IOI was reported at Month 7 without any anterior chamber inflammation. This event was mild with no effect on visual acuity. Per the investigator, the event was not drug- or injection procedure-related.
medicine 10,000+
As of March 2024
Over 35,000 vials distributed.‡ Countless moments preserved.
‡Includes samples and commercially distributed vials.

Low discontinuation rate (<2%) due to AEs in the GATHER clinical trials13

Patient retention measured by injection fidelity rates at 12 months
GATHER1
Injection fidelity rate
GATHER2
Injection fidelity rate
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.

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IMPORTANT SAFETY INFORMATION AND INDICATION
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.

To request medical information, please call 1-800-727-7003 or send an email to medinfo.americas@astellas.com. To report an adverse event or product complaint, please call 1-800-727-7003 or send an email to safety-us@astellas.com.