GATHER1 and GATHER2
Common ocular adverse reactions (≥2%) and greater than sham in study eye through 12 months7
IZERVAY (n=292)
Sham (n=332)
Conjunctival hemorrhage 13% 9%
Increased 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%

GATHER1
(0-12 months)

GATHER2†
(0-24 months)
Adverse events of special interest1,16,17
IZERVAY (n=67)
Sham (n=110)
IZERVAY (n=225)
Sham (n=222)
Intraocular inflammation (IOI), n‡ 1 0 1 0
Endophthalmitis, n 0 0 1§ 0
Ischemic optic neuropathy, n 0 0 0 0
Retinal vasculitis, n 0 0 0 0

  • Over 24 months, the rate of neovascular (wet) AMD or choroidal neovascularization in the GATHER2 trial was 12% in the IZERVAY group and 9% in the sham group7

*Blurred vision includes visual impairment, vision blurred, visual acuity reduced, visual acuity reduced transiently.

†The safety analysis set included all patients who received at least 1 dose of study drug.

‡In GATHER1, one case of IOI was reported at Month 7 without any antechamber inflammation. This event was mild with no effect on visual acuity. Per the investigator, the event was not drug- or injection procedure-related. In GATHER2, one case of nonserious IOI occurred during Year 2 of treatment. This event was reported as trace vitreous cells and was not related to the study drug or injection procedure.

§Culture positive.

AE=adverse event; AMD=age-related macular degeneration; GA=geographic atrophy.

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As of March 2025

Over 275,000 vials distributed.1|| Countless moments preserved.

||As of March 31, 2025. Based on samples and commercially distributed vials.

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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. Over 24 months, the rate of neovascular (wet) AMD or choroidal neovascularization in the GATHER2 trial was 12% in the IZERVAY group and 9% in the sham group. 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.