Safety

Proven safety through 2 years in the GATHER trials2

IZERVAY is the only FDA-approved GA treatment with no warning and precaution for intraocular inflammation or retinal vasculitis2,4

GATHER1 and GATHER2

Common ocular adverse reactions (≥2%) and greater than sham in study eye through 12 months2

IZERVAY

(n=292)

Sham

(n=332)
Conjunctival hemorrhage13%9%
Increased intraocular pressure (IOP)9%1%
Blurred vision*8%5%
Choroidal neovascularization (CNV)7%4%
Eye pain4%3%
Vitreous floaters2%<1%
Blepharitis2%<1%

GATHER1
(0-12 months)

GATHER2
(0-24 months)

Adverse events of special interest5,10,11

IZERVAY

(n=67)

Sham

(n=110)

IZERVAY

(n=225)

Sham

(n=222)
Intraocular inflammation (IOI), n1010
Endophthalmitis, n0010
Ischemic optic neuropathy, n0000
Retinal vasculitis, n0000

Dr. Kim: Talking to patients about GA and IZERVAY

Image of Dr. Esther Kim

Dr. Esther Kim shares how open conversations can help GA patients better understand their condition, feel empowered in their choice of treatment, and make informed choices that may preserve their vision for longer.1,2

The real-world safety profile across more than 400k vials of IZERVAY remains consistent with findings from the GATHER trials2,5§

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

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

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.

§As of 08/25. Based on samples and commercially distributed vials.

Learn more about IZERVAY

Next page

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.

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.