Izervay
Generic name: avacincaptad pegol
Dosage form: intravitreal injection
Drug class: Anti-angiogenic ophthalmic agents
What is Izervay?
Izervay injection is a C5 inhibitor used to treat geographic atrophy (GA), the advanced stage of age-related macular degeneration(AMD). Izervay injection helps slow down the progression of geographic atrophy, delaying vision deterioration and allowing patients to maintain better vision for a longer time. Geographic atrophy can lead to irreversible vision loss.
Izervay is given as an intravitreal injection (injection into the eye) every 28 days by your healthcare professional (HCP). Izervay contains the active ingredient avacincaptad pegol.
Izervay FDA approval is for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) for Iveric Bio, an Astellas Company, Astellas Pharma US, Inc. Izervay FDA approval was granted on August 4, 2023, after positive results from the GATHER1 and GATHER2 Phase 3 clinical trials.
What is geographic atrophy?
Geographic atrophy is a severe and progressive form of dry AMD that can lead to irreversible vision loss. Geographic atrophy begins as small damaged areas in the retina, gradually expanding and affecting central vision, which is essential for sharp, detailed sight. This damage is primarily caused by an overactive immune response known as the complement system.
How does Izervay work?
Izervay mechanism of action is a complement C5 inhibitor, specifically targeting C5, a key protein in the complement cascade. The complement cascade is a part of the immune system that, when overactive, damages retinal cells and speeds up geographic atrophy progression.
By blocking C5, the Izervay injection reduces the immune system's overactivity, protecting retinal cells from further harm and helping preserve vision over time.
How effective is Izervay?
Clinical Trials: GATHER1 & GATHER2
Izervay’s effectiveness was evaluated in two major clinical trials: GATHER1 (NCT02686658) and GATHER2 (NCT04435366). These studies measured the drug’s ability to slow GA progression over 12–24 months.
Key Results:
GATHER1 Trial (177 Participants)
- Izervay injection: GA lesion growth rate = 1.22 mm²/year
- Placebo injection: GA lesion growth rate = 1.89 mm²/year
- Izervay patients had a 35% reduction in GA lesion growth compared to placebo
GATHER2 Trial (447 Participants)
- Izervay injection: GA lesion growth rate = 1.75 mm²/year
- Placebo injection: GA lesion growth rate = 2.12 mm²/year
- Izervay patients had an 18% reduction in GA lesion growth compared to placebo
*% difference is calculated by 100*(difference)/(least squares mean from placebo)
Study Design:
- GATHER1: 67 participants received Izervay, 110 received placebo
- GATHER2: 225 participants received Izervay, 222 received placebo
- Participants ranged in age from 51 to 97 years (average age: 77 years)
Izervay Benefits
The benefits of Izervay injection are:
-
Reducing future damage to retinal cells
- Slowing the spread of GA lesions
- Delaying vision loss, helping to maintain eyesight longer.
Izervay side effects
Common Izervay side effects:
- Increased eye pressure (9% of patients)
- Blurred vision (8%)
- Conjunctival hemorrhage (bleeding in the white of the eye) (13%)
- Choroidal neovascularization (CNV) (7%)
- Eye pain (4%)
- Vitreous floaters (2%)
- Blepharitis (eyelid inflammation) (2%)
Serious side effects:
Do not use Izervay if you are allergic to Avacincaptad Pegol or any of its ingredients.
- Signs of eye infection (swelling, severe discomfort, crusting, drainage)
- Severe eye redness or pain
- Increased sensitivity to light
- Blurred or cloudy vision
- Visual disturbances, such as flashes of light
Important: This is not a complete list of side effects. Contact your doctor for medical advice if you experience any adverse reactions. You may report side effects to the FDA at 1-800-FDA-1088.
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Warnings and precautions
- Endophthalmitis and retinal detachments
- Neovascular AMD
- Increase in intraocular pressure (IOP).
Before using this medicine
You should not use Izervay injection if you have ocular or periocular infections or active intraocular inflammation.
Tell your doctor if you are pregnant or breastfeeding.
How should I receive Izervay?
Izervay injections are given as intravitreal injections, which means the medication is injected directly into the vitreous humor in the eye.
The injection usually just takes a few seconds. Your retina specialist will numb your eye first with a topical anesthetic, so you will feel little to no pain, although you may feel some pressure during the injection. Your doctor will monitor the pressure inside your eye before and after the injection.
by a qualified physician
Before use, allow Izervay to reach room temperature, 20⁰C to 25⁰C (68⁰F to 77⁰F).
Izervay Myway
Izervay My Way may help you with the cost of Izervay whether you have commercial insurance, insurance that doesn’t cover this medicine, are uninsured, or have government-issued insurance (such as Medicare). Izervay My Way is a financial assistance program by for US residents by Astellas Pharma Inc.
To find out if you are eligible for the Izervay My Way program, talk to your doctor, see our Izervay Prices, Coupons, Copay Cards & Patient Assistance page or call call 1-888-C5MYWAY (1-888-256-9929).
To find out about insurance coverage see “Is Izervay covered by your insurance plan? How to check?”
Izervay dosing information
Usual adult Izervay dose for macular degeneration:
Recommended dose: 2 mg intravitreal injection given once monthly (28 ± 7 days)
General dose information:
- Before the intravitreal injection, check the intraocular pressure (IOP).
- If necessary, ocular hypotensive medicine can be administered to reduce IOP.
Izervay injection is available: as a 2 mg (0.1 mL of 20 mg/mL) solution in a single-dose vial.
What happens if I miss a dose?
Make an appointment or call your qualified physician as soon as you realize you have missed your dose to organize a new appointment.
What should I avoid with Izervay?
You may experience temporary visual disturbances and blurring, after having your injection and the associated eye examinations. Avoid driving or using machinery until the visual function has recovered sufficiently.
What other drugs will affect Izervay?
Other drugs may interact with this medicine. Tell your doctor about all the other medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal products.
Izervay J code
Izervay J code is J2782
Your physician will need the Izervay J code when filling out forms for your treatment.
J codes are used for medicines that are not taken orally and include injections, inhalations chemotherapies. J codes are important for accurate and consistent coding for billing and reimbursement purposes
Izervay Package Insert
Review the Izervay Prescribing Information for more detailed information about this medicine. Discuss any medical questions with your doctor or other health care provider. This is not all the information you need about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.
Storage
- Store in the refrigerator between 2°C to 8°C (36°F to 46°F).
- Do not freeze. Do not shake.
- Keep the vial in the original carton to protect it from light.
Before use
- Prior to use, the unopened glass vial may be kept at room temperature, 20°C to 25°C (68°F to 77°F), for up to 24 hours.
- Ensure that the injection is given immediately after preparation of the dose.
Ingredients
Active ingredient: avacincaptad pegol (oligonucleotide basis),
Inactive ingredients: 0.198 mg dibasic sodium phosphate heptahydrate, 0.0256 mg monobasic sodium phosphate monohydrate, and 0.83 mg sodium chloride. It is formulated in Water for Injection, with a target pH of 7.3. This medicine does not contain an anti-microbial preservative.
Izervay Manufacturer
Izervay Iveric Bio, an Astellas Company, Astellas Pharma US, Inc.
Popular FAQ
How do Izervay and Syfovre compare?
Izervay (avacincaptad pegol) and Syfovre (pegcetacoplan) are injectable treatments for geographic atrophy (GA), a severe form of age-related macular degeneration (AMD) that causes progressive and irreversible vision loss. Continue reading
Is Izervay covered by your insurance plan? How to check?
To check if Izervay (avacincaptad pegol) is covered by your insurance, call them and ask about your prescription benefits. A representative can help you determine if the medication is on your plan’s formulary, and how much your copay would be. Continue reading
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.