Izervay (avacincaptad pegol)
An approved treatment for Geographic Atrophy.
The same compound appears under different names depending on the context. Here is how to identify Avacincaptad pegol wherever you encounter it, plus the key facts at a glance.
- Generic name
- Avacincaptad pegol
- Brand name
- Izervay
- Development code
- ARC1905
- Drug class
- Complement C5 inhibitor (intravitreal RNA aptamer)
- Manufacturer
- Astellas Pharma (developed by Iveric Bio, which Astellas acquired in July 2023)
- How it's taken
- Each dose is 2 mg (0.
An eye injection given once a month to slow the growth of geographic atrophy (GA), the advanced form of dry age-related macular degeneration. The FDA approved it on August 4, 2023, and on February 12, 2025 approved a label update that removed the original 12-month limit on treatment. In 2 main trials it slowed the yearly growth of GA lesions by 14% to 35% compared with sham (mock) injections, depending on the trial and time point.
Where Avacincaptad pegol fits
Izervay is 1 of 2 FDA-approved treatments for geographic atrophy, both complement inhibitors injected into the eye. Izervay blocks C5, while pegcetacoplan (Syfovre, approved February 17, 2023) blocks C3. The Izervay label contains no head-to-head trial against Syfovre[#syfovre-letter][#izervay-label].
How Avacincaptad pegol works
In GA, cells in the macula (the center of the retina) die off in spreading patches, and the GATHER1 researchers note that complement, part of the immune system, may play a key role in the disease[7]. Avacincaptad pegol is an aptamer, a short strand of RNA folded so it grips a single target, attached to polyethylene glycol (PEG). It binds complement protein C5 and stops C5 from being split into C5a and C5b, which cuts formation of the membrane attack complex, a structure that punches holes in cells. In the trials, this slowed how fast GA lesions grew, which the label ties to slower loss of light-sensing photoreceptor cells[1]. It does not reverse damage GA has already done[13].
Mechanism: PEGylated RNA aptamer injected into the eye that binds complement protein C5, blocking its cleavage into C5a and C5b and reducing formation of the membrane attack complex
Side effects and safety
- Endophthalmitis and retinal detachment. Eye injections can cause a serious infection inside the eye or separation of the retina. Report eye pain, redness, light sensitivity, blurred or reduced vision, new floaters or flashes of light right away.
- Wet AMD (choroidal neovascularization). Developed in 7% on monthly Izervay against 4% on sham by month 12, and in 12% against 9% over 24 months in GATHER2. Report straight lines looking bent, dark spots or loss of central vision.
- Raised eye pressure. Eye pressure can rise briefly after the injection, so it is checked before and right after each one.
- Eye pressure checked before each injection
- Optic nerve blood flow or eye pressure checked right after each injection
- Regular eye exams for signs of wet AMD
Izervay has no boxed warning. It must not be used when there is an infection in or around the eye or active inflammation inside the eye. Like other eye injections, it can cause endophthalmitis (a serious infection inside the eye) and retinal detachment, and eye pressure can rise briefly after each injection. The label also warns about wet AMD (abnormal new blood vessels, called choroidal neovascularization): by month 12 it developed in 7% of patients on monthly Izervay against 4% on sham, and over 24 months in GATHER2 in 12% against 9%. Across the first 12 months of both trials, the most common side effects against sham were bleeding on the white of the eye (conjunctival hemorrhage, 13% against 9%), raised eye pressure (9% against 1%), blurred vision (8% against 5%) and eye pain (4% against 3%). Over 24 months in GATHER2 they included conjunctival hemorrhage (17% against 9%), blurred vision (14% against 5%), raised eye pressure (13% against 1%) and punctate keratitis, small spots of irritation on the cornea (10% against 8%)[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Avacincaptad pegol
Each dose is 2 mg (0.1 mL) injected into the vitreous, the gel inside the eye, by a qualified physician, once a month (about every 28 days, give or take 7 days) in each affected eye. The injection is done under sterile conditions after numbing and an antiseptic, with a separate vial for each eye. Since February 12, 2025, the label has no set limit on how long treatment can continue. Vision may be blurry for a while after the injection and eye exam, so patients should not drive or use machinery until it recovers[1][3].
Availability and cost
Only available as the brand-name product.
Help paying for Izervay
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
IZERVAY Commercial Copay Program: eligible commercially insured patients 18 and older whose plan covers Izervay may pay as little as $0. Maximum benefit of $20,000 a calendar year for the drug cost share and $1,500 a calendar year for the administration cost share. Massachusetts residents or patients treated there get help with the drug cost only. Payment goes to the eye care professional; claims are due within 180 days of the explanation of benefits. Not valid with Medicare, Medicaid, Medigap, VA, DoD, TRICARE or for self-pay patients.
For: private insurance · source - Free medicine program
Astellas Patient Assistance Program: Izervay at no cost for patients 18 and older in the 50 states, DC or Puerto Rico who are uninsured, insured without coverage for Izervay after completing available appeals, or on Medicare Part B with coverage but unable to afford the cost-sharing. Gross annual household income must be $150,000 or less. Enrollment lasts the calendar year.
For: no insurance, underinsured, Medicare · source - Insurance and case manager help
IZERVAY My Way helps patients with commercial insurance, insurance that does not cover Izervay, no insurance, or government insurance such as Medicare find financial help. Call 1-888-C5MYWAY (1-888-256-9929), Monday to Friday, 8 AM to 8 PM ET. Product questions: 1-800-727-7003.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: Astellas's pricing page (izervaycost.com) shows a list price of $2,100 per month based on August 2024 data; it was not added to the drug entry because it may be out of date.
Access and eligibility
Approved for geographic atrophy secondary to age-related macular degeneration, in each affected eye. Not used when there is an eye infection or active inflammation inside the eye. Safety and effectiveness in children have not been established, and the GATHER trials enrolled people aged 50 and older.
Source: IZERVAY My Way (Astellas)
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
Approval rested on 2 sham-controlled trials in people with GA from AMD, in which lesion size was measured with fundus autofluorescence imaging. In GATHER1 (NCT02686658), which enrolled 286 people and tested 2 mg and 4 mg doses, lesions grew 1.22 mm² in the first year on the approved 2 mg dose against 1.89 mm² on sham, 35% slower[1][7]. In GATHER2 (NCT04435366), with 448 people, lesions grew 1.75 mm² against 2.12 mm² in year 1, 18% slower[1][8][11]. Over 2 years of monthly dosing in GATHER2, the yearly growth rate was 2.23 mm² against 2.59 mm², 14% slower, and people switched to every-other-month injections in year 2 had a rate of 2.10 mm² a year[1][9]. The main goal in both trials was slower lesion growth, not better vision.
Development history
Iveric Bio developed avacincaptad pegol, which was earlier called Zimura and ARC1905[10]. Astellas completed its purchase of Iveric Bio, for about $5.9 billion, on July 11, 2023[5], and the FDA approved Izervay for geographic atrophy secondary to AMD on August 4, 2023[2][4]. The original label limited dosing to 12 months. After an FDA action letter in November 2024 and a resubmission in December 2024, the FDA approved a label update on February 12, 2025 that added 2-year GATHER2 results and removed the limit on how long treatment can last[3][6].
Explore Geographic Atrophy trials
Common questions about Avacincaptad pegol
▸What is Avacincaptad pegol (Izervay)?
An eye injection given once a month to slow the growth of geographic atrophy (GA), the advanced form of dry age-related macular degeneration. The FDA approved it on August 4, 2023, and on February 12, 2025 approved a label update that removed the original 12-month limit on treatment. In 2 main trials it slowed the yearly growth of GA lesions by 14% to 35% compared with sham (mock) injections, depending on the trial and time point.
▸How does Avacincaptad pegol work?
In GA, cells in the macula (the center of the retina) die off in spreading patches, and the GATHER1 researchers note that complement, part of the immune system, may play a key role in the disease[7]. Avacincaptad pegol is an aptamer, a short strand of RNA folded so it grips a single target, attached to polyethylene glycol (PEG). It binds complement protein C5 and stops C5 from being split into C5a and C5b, which cuts formation of the membrane attack complex, a structure that punches holes in cells. In the trials, this slowed how fast GA lesions grew, which the label ties to slower loss of light-sensing photoreceptor cells[1]. It does not reverse damage GA has already done[13].
▸What are the side effects of Avacincaptad pegol?
Izervay has no boxed warning. It must not be used when there is an infection in or around the eye or active inflammation inside the eye. Like other eye injections, it can cause endophthalmitis (a serious infection inside the eye) and retinal detachment, and eye pressure can rise briefly after each injection. The label also warns about wet AMD (abnormal new blood vessels, called choroidal neovascularization): by month 12 it developed in 7% of patients on monthly Izervay against 4% on sham, and over 24 months in GATHER2 in 12% against 9%. Across the first 12 months of both trials, the most common side effects against sham were bleeding on the white of the eye (conjunctival hemorrhage, 13% against 9%), raised eye pressure (9% against 1%), blurred vision (8% against 5%) and eye pain (4% against 3%). Over 24 months in GATHER2 they included conjunctival hemorrhage (17% against 9%), blurred vision (14% against 5%), raised eye pressure (13% against 1%) and punctate keratitis, small spots of irritation on the cornea (10% against 8%)[1].
▸How is Avacincaptad pegol taken?
Each dose is 2 mg (0.1 mL) injected into the vitreous, the gel inside the eye, by a qualified physician, once a month (about every 28 days, give or take 7 days) in each affected eye. The injection is done under sterile conditions after numbing and an antiseptic, with a separate vial for each eye. Since February 12, 2025, the label has no set limit on how long treatment can continue. Vision may be blurry for a while after the injection and eye exam, so patients should not drive or use machinery until it recovers[1][3].
▸Is Avacincaptad pegol FDA approved?
Yes, Avacincaptad pegol (Izervay) is FDA approved (2023) for the treatment of Geographic Atrophy.
▸How often do you get Izervay injections?
The label dose is 2 mg injected into each affected eye once a month, about every 28 days give or take 7 days. Since a label update on February 12, 2025, there is no set limit on how long treatment can continue. In GATHER2, people switched to every-other-month injections in the second year had a GA growth rate of 2.10 mm² a year, but the approved schedule remains monthly.
▸Does Izervay improve vision?
No. Izervay is approved to slow the growth of geographic atrophy lesions, and Astellas says it will not reverse damage GA has already done. In the trials, the main measure was how fast lesions grew: 35% slower than sham in GATHER1 and 18% slower in GATHER2 over the first year.
▸What is the difference between Izervay and Syfovre?
Both are complement inhibitors injected into the eye to slow geographic atrophy. Izervay (avacincaptad pegol, Astellas) blocks complement protein C5 and was approved on August 4, 2023. Syfovre (pegcetacoplan, Apellis) blocks C3 and was approved on February 17, 2023. The Izervay label has no head-to-head trial against Syfovre, so results from their separate trials cannot be directly compared.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed · 2026-09. IZERVAY (avacincaptad pegol intravitreal solution): prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1642fe6a-dc26-4d20-ae6e-654af744e3bd
- U.S. Food and Drug Administration · 2023-08-04. NDA 217225 approval letter. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217225Orig1s000ltr.pdf
- U.S. Food and Drug Administration · 2025-02-12. NDA 217225/S-001 supplement approval (expanded dosing beyond 12 months). https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217225Orig1s001ltr.pdf
- Astellas Pharma · 2023-08-05. Iveric Bio receives U.S. FDA approval for IZERVAY (avacincaptad pegol intravitreal solution), a new treatment for geographic atrophy. https://newsroom.astellas.com/2023-08-05-Iveric-Bio-Receives-U-S-FDA-Approval-for-IZERVAY-TM-avacincaptad-pegol-intravitreal-solution-,-a-New-Treatment-for-Geographic-Atrophy
- Astellas Pharma · 2023-07-11. Astellas completes acquisition of Iveric Bio. https://newsroom.astellas.com/2023-07-11-Astellas-Completes-Acquisition-of-Iveric-Bio
- Astellas Pharma · 2025-02-13. U.S. FDA approves expanded label for Astellas' IZERVAY (avacincaptad pegol intravitreal solution) for geographic atrophy. https://newsroom.astellas.com/2025-02-13-U-S-FDA-Approves-Expanded-Label-for-Astellas-IZERVAY-TM-avacincaptad-pegol-intravitreal-solution-for-Geographic-Atrophy
- Ophthalmology · 2021. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial. https://doi.org/10.1016/j.ophtha.2020.08.027
- The Lancet · 2023. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. https://doi.org/10.1016/S0140-6736(23)01583-0
- Ophthalmology · 2026. Avacincaptad Pegol for Geographic Atrophy Secondary to Age-Related Macular Degeneration: Two-Year Efficacy and Safety Results from the GATHER2 trial. https://doi.org/10.1016/j.ophtha.2025.12.011
- ClinicalTrials.gov. Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration (GATHER1). https://clinicaltrials.gov/study/NCT02686658
- ClinicalTrials.gov. A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor) (GATHER2). https://clinicaltrials.gov/study/NCT04435366
- U.S. Food and Drug Administration · 2023-02-17. NDA 217171 approval letter (Syfovre, pegcetacoplan injection). https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217171Orig1s000ltr.pdf
- Astellas Pharma. IZERVAY (avacincaptad pegol intravitreal solution) official patient website. https://www.izervay.com/