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

ACT EARLY

Take the next step against GA progression

A prompt referral for IZERVAY can make a significant difference. See how Dr. Chris Wolfe communicates the advantage of starting IZERVAY early to his patients.

Prepare 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 slowed GA growth as early as 6 months and significantly in just 12 months4

Reductions in mean rate of GA growth (MMRM analysis) at 12 months vs sham4:

*Twelve months: (95% CI) mm2/year=0.67 (0.21-1.13).
Six months: (95% CI) mm2/year=0.323 (0.068-0.579).4,10

†Twelve months: (95% CI) mm2/year=0.38 (0.12-0.63).
Six months: (95% CI) mm2/year=0.188 (0.061, 0.315).4,10

Trial Design: The safety and efficacy of IZERVAY were demonstrated in GATHER1 and GATHER2: 2 randomized, multicenter, double-masked, sham-controlled studies in patients with age-related macular degeneration. 292 patients were treated with IZERVAY 2 mg, and 332 patients received sham. The primary efficacy endpoint in GATHER1 (n=177) and GATHER2 (n=447) was the mean rate of GA growth (slope) from baseline to Month 12 over 3 timepoints: baseline, Month 6, and Month 12.4

MMRM=mixed models for repeated measure.

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

Observed effect doubled from Months 6 to 1210

Given the exploratory post hoc nature of the data, these results should be interpreted with caution and cannot be considered conclusive. This is a simplified piecewise slope spline multivariate and repeated measures analysis.

Consistent safety

The only FDA-approved GA treatment with no Warning and Precaution for intraocular inflammation or retinal vasculitis4,11

No reported cases of permanent vision loss due to adverse events in the 12-month GATHER clinical trials.12,13

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.

The only GA treatment with RNA aptamer technology4

IZERVAY is designed differently to directly target the source of retinal cell death.4,15

Designed Differently

TARGETS DIFFERENTLY

Only IZERVAY directly targets C5, preserving upstream homeostasis of the complement system4,15

RNA=ribonucleic acid.

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Patient resources

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Patient brochure

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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. 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. 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.