Izervay

Izervay (avacincaptad pegol) is a prescription injection used for geographic atrophy (GA), the advanced stage of age-related macular degeneration(AMD), to help preserve vision. Izervay is a C5 inhibitor that helps slow down the progression of geographic atrophy, delaying vision deterioration and allowing patients to maintain better vision for a longer time.

Izervay works by targeting C5 complement, a protein that is a part of the immune system, and 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.

Izervay belongs to a group of medicines called complement inhibitors.

Izervay is administered every 28 days as an intravitreal injection (injection into the eye) by your healthcare professional (HCP).

Izervay patients had a 35% reduction in GA lesion growth compared to placebo, in the GATHER1 Trial.

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 a placebo.
• GATHER2: 225 participants received Izervay, 222 received a placebo.
• Participants ranged in age from 51 to 97 years (average age: 77 years)

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.

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.

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 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 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 1-888-C5MYWAY (1-888-256-9929).

To find out about insurance coverage, see “Is Izervay covered by your insurance plan? How to check?”

• Endophthalmitis and retinal detachments
• Neovascular AMD
• Increase in intraocular pressure (IOP).

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.

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

After Izervay Treatment

Patients may be at risk for serious eye conditions, including neovascular AMD, eye infections, increased eye pressure, and retinal detachment.

Seek immediate medical attention if you notice:

• Red, painful, or light-sensitive eyes
• Any vision changes

Temporary effects: Blurred vision may occur after injection. Avoid driving or using machinery until your vision returns to normal.

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.

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.

Make an appointment or call your qualified physician as soon as you realize you have missed your dose to organize a new appointment.

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.

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 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

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.

• 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

• Before 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.

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 antimicrobial preservative.

Izervay Iveric Bio, an Astellas Company, Astellas Pharma US, Inc.