IZERVAY™ 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)
Data on file. IVERIC bio, Inc., Parsippany, NJ 07054.
Kaiser PK, Khanani AM, Eichenbaum DA, et al. Safety of intravitreal avacincaptad pegol in geographic
atrophy: GATHER1 and GATHER2 results. Presented at the Retina Society 55th Annual Scientific Meeting;
November 2-5, 2022; Pasadena, CA.
Sarda SP, Heyes A, Bektas M, et al. Humanistic and economic burden of geographic atrophy: A systematic
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Chakravarthy U, Bailey CC, Johnston RL, et al. Characterizing disease burden and progression of
geographic
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Ophthalmol. 2018;125(6):842-849.
Chakravarthy U, Anegondi N, Steffen V, Ferrara D. Visual functional loss in geographic atrophy (GA):
learnings from lampalizumab trial data. Presented at Macula Society 2023 Annual Meeting; February 15-18,
2023; Miami, FL.
Boyer DS, Schmidt-Erfurth U, van Lookeren Campagne M, Henry EC, Brittain C. The pathophysiology of
geographic atrophy secondary to age-related macular degeneration and the complement pathway as a
therapeutic
target.
Retina. 2017;37(5):819-835.
Fleckenstein M, Mitchell P, Freund KB, et al. The progression of geographic atrophy secondary to
age-related macular degeneration.
Ophthalmol. 2018;125(3):369-390.
Desai D, Dugel PU. Complement cascade inhibition in geographic atrophy: a review.
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IQVIA Medical Claims (Dx) Data Jan’20-Dec’21: 24 Months.
Danzig C, Kaiser PK, Lally DR, et al. Intravitreal avacincaptad pegol in geographic atrophy: post hoc
analysis of vision loss from the GATHER Clinical Program. Presented at Association for Research in Vision
and Ophthalmology (ARVO); April 23-27, 2023; New Orleans, LA.
Khanani AM. Patel SS, Staurenghi G, et al. GATHER2 pivotal phase 3 study results: efficacy of
intravitreal
avacincaptad pegol in geographic atrophy. Presented at the Retina Society 55th Annual Scientific Meeting;
November 2-5, 2022; Pasadena, CA.
Khanani AM. Patel SS, Staurenghi G, et al. GATHER2 pivotal phase 3 study results: efficacy of
intravitreal
avacincaptad pegol in geographic atrophy. Presented at the American Academy of Ophthalmology Annual
Meeting;
September 30-October 3, 2022; Chicago, IL.
Park DH, Connor KM, Lambris JD. The challenges and promise of complement therapeutics for ocular
diseases.
Front Immunol. 2019;10:1007.
Ricklin D, Hajishengallis G, Yang K, Lambris JD. Complement: a key system for immune surveillance and
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Boyer DS, Schmidt-Erfurth U, van Lookeren Campagne M, Henry EC, Brittain C. The pathophysiology of
geographic atrophy secondary to age-related macular degeneration and the complement pathway as a
therapeutic
target.
Retina. 2017;37(5):819-835.