How effective is Syfovre for macular degeneration?

In two 24-month long clinical studies, monthly eye injections with Syfovre slowed geographic atrophy lesion growth rate (retinal cell loss) by 18% to 22%. Injections given every other month slowed the lesion growth rate by 17% to 18%. Syfovre is used to treat geographic atrophy secondary to age-related macular degeneration.

Geographic atrophy (GA) is a progressive and irreversible form of dry age-related macular degeneration (AMD) and is a leading cause of blindness. Geographic atrophy lesions grow and can spread to the center of the retina, which is needed for sharp vision. These lesions can eventually cause vision loss and blindness.

Although GA cannot be cured, treatment with Syfovre can slow down the lesion growth and disease worsening.

Syfovre studies

In the 24-month OAKS and DERBY Phase 3 studies with a total of 1258 randomized patients, Syfovre 15 mg injection showed a slowing in the growth of areas of retinal cell loss.

The results were compared to outcomes in patients who received sham controlled therapy that mimicked the actual procedure but without active medicine. Patients ranged in age from 60 to 100 years (mean age 78.7 years).

Mean (standard deviation) total area of GA lesions(s) at baseline (the start of the study) in the study eye (in mm² ) were 8.23 and 8.29 for OAKS and DERBY studies, respectively

• In the OAKS trial (637 participants), monthly Syfovre injections slowed GA lesion growth by 22% (-0.87 mm²), and every other month injections slowed GA lesion growth by 18% (-0.72 mm²).
• In the DERBY trial (621 participants), monthly Sofovre injections slowed lesion growth by 18% (-0.73 mm²), and every other month injections slowed lesion growth by 17% (-0.70 mm²).

How does Syfovre work in geographic atrophy?

Syfovre (generic name: pegcetacoplan) works in geographic atrophy (GA) by inhibiting C3, a protein in the complement system (part of the immune system) that may be involved in the death of retinal cells in age-related macular degeneration (AMD). In GA, cell death in areas of the retina may result in dim or dark spots in the central vision.

Clinically, Syfovre helps to slow the growth of geographic atrophy (GA) lesions and preserve vision by reducing vision loss and blindness.

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How is Syfovre injected and is it painful?

Syfovre is given as an injection into the back of your eye (called an intravitreal injection) once every 25 to 60 days, usually in your retina specialist’s office or clinic. Your doctor will determine how often you will receive your treatment.

The intravitreal injection takes about a total of 10 to 15 minutes. Your retina specialist (a specialized ophthalmologist) will numb your eye first with a topical anesthetic. The injection is not painful but you may feel some pressure during the injection.

There are usually no restrictions after the injection, but your vision may be impaired or blurry. Do not drive or operate machinery until your vision recovers. Severe complications are rare after intravitreal injections.

Side effects with Syfovre

The most common side effects with Syfovre include:

• Ocular (eye) discomfort
• Neovascular age-related macular degeneration
• Vitreous floaters (small specks floating in your vision)
• Conjunctival hemorrhage (bleeding).

You should not receive Syfovre if you have an eye infection, or swelling which may include pain and redness in or around your eye.

Warnings and precautions associated with Syfovre include:

• An infection and inflammation of the eye (endophthalmitis) and retinal detachments
• Neovascular (wet) AMD
• Intraocular inflammation
• Increased intraocular pressure.

You should seek immediate medical care from an ophthalmologist if the affected eye becomes red, sensitive to light, painful, or if there is any change in vision such as flashing lights, black spots, loss of vision, blurred or wavy vision, or metamorphopsia (straight lines appear warped).

This is not all the information you need to know about Syfovre (pegcetacoplan) for safe and effective use and does not take the place of your healthcare provider’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.