Now approved for use beyond 12 months10
The #1 prescribed FDA-approved treatment for new GA patients12*

*Based on Symphony data from 3/24-1/25. May not represent entire patient population.

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For US Healthcare Professionals Only IzervayECP.com Full Prescribing Information References
For US Healthcare
Professionals Only

Act early with IZERVAY

Early treatment intervention offers an opportunity to slow geographic atrophy (GA) progression.2,3,10

Dr. Chris Wolfe’s tips for preparing your patients for IZERVAY

  • Be direct. Explain the natural progression of GA
  • Tell the patient what you're seeing. Share images to help your patient better understand their condition
  • Make a recommendation for treatment. Referring early offers the opportunity to get ahead of GA progression

IZERVAY is the only treatment to demonstrate a statistically significant reduction in the rate of GA growth across two Phase 3 trials at 12 months10,11

Reductions in mean rate of GA growth (MMRM analysis) at 12 months vs sham10:

*Twelve months: (95% CI) mm2/year=0.67 (0.21‑1.13).10

‡Twelve months: (95% CI) mm2/year=0.38 (0.12‑0.63).10

Proven with 2 years of data,

IZERVAY continued to slow lesion growth through 24 months
and demonstrated an increasing treatment effect10

The annualized rate of GA growth (MMRM analysis)§ at 24 months in GATHER2

IZERVAY 2 mg EM

  • 2.23 mm2/year
  • 14% reduction at 24 months; difference vs sham (95% CI) mm2/year†=0.36 (0.07‑0.66); p=0.0165

IZERVAY 2 mg EM to EOM

  • 2.10 mm2/year
  • Due to hierarchical testing procedure, no statistical test was performed for the EOM treatment group

The recommended dose for IZERVAY is 2 mg once monthly (approximately 28 ± 7 days)

§Non-transformed GA growth slope analysis.

†Percent difference is calculated by 100×(difference)/(least square mean from sham).

CI=confidence interval; MMRM=mixed models for repeated measure.

Trial Design: The efficacy and safety of IZERVAY were demonstrated in 2 randomized, multicenter, double-masked, sham-controlled, 18‑month and 24‑month studies in patients with GA due to AMD. The primary endpoint evaluated the mean rate of GA growth (slope) from baseline to Month 12, measured by FAF at 3 time points (baseline, Month 6, and Month 12). In GATHER2, the mean rate of GA growth (slope) measured by FAF was evaluated at 2 additional time points (Month 18 and Month 24).10

Patients continuing in the study through 24 months and originally randomized to the IZERVAY 2‑:mg arm at the outset of the study were re-randomized at Month 12 to either continue to receive IZERVAY every month (EM) (n=96) or receive IZERVAY every other month (EOM) (n=93). Patients treated with sham in the first 12 months continued monthly sham treatment.10,12

For additional IZERVAY clinical trial data, visit IzervayECP.com.

The only FDA-approved GA treatment with no Warning and Precaution for intraocular inflammation or retinal vasculitis10,11

Safety data observed in patients with GA secondary to AMD up to 24 months were consistent with those seen at 12 months10

  • 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 group10

∥Blurred vision includes visual impairment, vision blurred, visual acuity reduced, and 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.12,14

#Culture positive.12

IZERVAY is made to work differently

Only IZERVAY directly targets C5, preserving the upstream
homeostasis of the complement system10,15

TARGETS DIFFERENTLY

By inhibiting C5, IZERVAY may10,17

  • Reduce inflammation
  • Reduce retinal cell death
  • Reduce loss of photoreceptors

RNA=ribonucleic acid.

IZERVAYECP.com

Learn more about IZERVAY

Patient resources

Help support your patients in taking charge of their treatment with IZERVAY.

Find a practice experienced with IZERVAY

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Patient brochure

Download this brochure to inform your patients about IZERVAY.

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IMPORTANT SAFETY INFORMATION AND INDICATION

INDICATION

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

CONTRAINDICATIONS

IZERVAY is contraindicated in patients with ocular or periocular infections and in patients with active intraocular inflammation.

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.

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.

Images courtesy of Heidelberg Engineering, Dr. Julie Rodman, and Dr. Mohammad Rafieetary.