Generic name: avacincaptad pegol
Dosage form: intravitreal injection
Drug class: Anti-angiogenic ophthalmic agents
What is Izervay?
Izervay (avacincaptad pegol) injection is a treatment for geographic atrophy (GA), which is 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).
Izervay FDA approval is for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) for Astellas Pharma Inc. The FDA approval was granted on August 4, 2023.
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 helps slow the progression of GA by targeting an overactive immune system response that has a damaging effect on the retinal cells.
Izervay mechanism of action is a complement inhibitor, specifically targeting C5, a key protein in the complement cascade—a part of the immune system that when overactive, damages retinal cells and speeds up GA progression.
By blocking C5, Izervay reduces immune overactivity and slows GA progression.
Benefits of Izervay Treatment:
- Reduces future damage to retinal cells
- Slows the spread of GA lesions
- Delays vision loss, helping to maintain eyesight longer.
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
- 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
- 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 Side Effects
Common 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 .
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 by a qualified physician as intravitreal injections, which means the medication is injected directly into the vitreous humor in the eye. Your doctor will monitor the pressure inside your eye before and after the injection.
Before use, allow Izervay to reach room temperature, 20⁰C to 25⁰C (68⁰F to 77⁰F).
Izervay cost
The cost of this medicine may vary depending on your insurance plan. You may also be eligible for a financial assistance program.
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.
