Is Izervay approved by the FDA?

Yes, Izervay, which is the brand name for avacincaptad pegol, received FDA approval on August 4, 2023. It is approved for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Uses

Izervay is specifically designed to treat geographic atrophy (GA), a severe form of age-related macular degeneration (AMD). Geographic atrophy is characterized by the progressive degeneration of the retina, which can lead to irreversible vision loss. Izervay helps slow down the progression of this condition, thereby preserving vision for a longer period.

Mechanism of Action

Izervay works as a complement C5 protein inhibitor. In the case of geographic atrophy caused by AMD, an overactive complement system (part of the immune system) contributes to the damage and scarring of the retina. By inhibiting the complement protein C5, Izervay reduces the activity of the complement cascade, potentially slowing down the progression of retinal damage and geographic atrophy.

Dosage and Administration

• Recommended dosage: 2 mg intravitreal injection once monthly (every 28 ± 7 days).
• Administration: The injection is administered directly into the vitreous humor of the eye by a qualified physician. Intraocular pressure is monitored before and after the injection.

Effectiveness

Izervay is effective in slowing the progression of geographic atrophy secondary to AMD. By inhibiting the complement system, it helps maintain better vision over time.

Side Effects

Common side effects:

• Increased pressure inside the eye (9%)
• Blurred vision (8%)
• Bleeding in the white part of the eye (9%)
• Neovascular age-related macular degeneration (7%)

Serious side effects:

• Signs of eye infection (swelling, severe discomfort, crusting or drainage)
• Severe eye redness or pain
• Increased sensitivity to light
• Blurred or cloudy vision
• Changes in vision, such as seeing flashes of light

Patients are advised to call their doctor for medical advice about side effects and to report any adverse effects to the FDA at 1-800-FDA-1088.

Warnings and Precautions

• Contraindications: Do not use Izervay if you have ocular or periocular infections or active intraocular inflammation.
• Pregnancy and Breastfeeding: Inform your doctor if you are pregnant or breastfeeding. Discuss the risks and benefits with your healthcare provider.

Storage and Handling

• Store Izervay in the refrigerator between 2°C to 8°C (36°F to 46°F).
• Do not freeze or shake the vial.
• Keep the vial in its original carton to protect it from light.
• Before use, allow the unopened glass vial to reach room temperature (20°C to 25°C / 68°F to 77°F) for up to 24 hours.

Summary

Izervay, approved by the FDA on August 4, 2023, provides a crucial treatment option for patients with geographic atrophy secondary to age-related macular degeneration. By inhibiting the complement C5 protein, Izervay helps slow the progression of this vision-threatening condition, offering hope for better vision preservation.

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