Syfovre (pegcetacoplan) injection is used to treat geographic atrophy (GA), which is the dry advanced form of age-related macular degeneration (AMD).  Syfovre is a complement inhibitor that works to slow the growth of GA lesions, to help preserve vision by reducing more significant vision loss and blindness.

Syfovre is the first and only FDA approved for the treatment of geographic atrophy secondary to age-related macular degeneration.

Geographic atrophy lesions are areas in the retina that are damaged due to age-related macular degeneration. Over time the geographic atrophy lesion(s) become larger and can spread to the center of the retina (fovea), which is the area that is most important for the sharpest vision. It is the progression of the lesion over the fovea that causes vision loss and blindness. 

Syfovre injections have been shown in Phase 3 OAKS clinical trial and Phase 3 Derby studies to slow the growth and spread of GA lesions, which can help preserve vision.

You should NOT receive Syfovre if you:

• have an infection in or around your eye
• have any active swelling around or in your eye that may include pain and redness

What should I tell my doctor before receiving  Syfovre?

Tell your healthcare provider if:

• If in the past you have seen flashes of light or small specks floating in your vision and if you have a sudden increase of size and number of these specks.
• If you have high eye pressure or if you have glaucoma.

Pregnancy

Tell  your doctor if you are pregnant or planning to become pregnant. 

Women able to become pregnant should use effective contraception methods to prevent pregnancy during treatment with this medicine and for 40 days after the last dose. For women planning to become pregnant, the use of Syfovre may be considered following an assessment of the risks and benefits.

Breastfeeding

Ask your doctor for advice before taking this medicine if you are breastfeeding or planning to breastfeeding, your doctor will talk to you about about the best way to feed your baby.

Tell your healthcare provider if:

• If in the past you have seen flashes of light or small specks floating in your vision and if you have a sudden increase of size and number of these specks.
• If you have high eye pressure or if you have glaucoma.

Pregnancy

Tell  your doctor if you are pregnant or planning to become pregnant. 

Women able to become pregnant should use effective contraception methods to prevent pregnancy during treatment with this medicine and for 40 days after the last dose. For women planning to become pregnant, the use of Syfovre may be considered following an assessment of the risks and benefits.

Breastfeeding

Ask your doctor for advice before taking this medicine if you are breastfeeding or planning to breastfeeding, your doctor will talk to you about about the best way to feed your baby.

How will I received Syfovre?

Syfovre is given as an injection into the vitreous (the soft gel in the middle of your eye) by a qualified physician. 

Syfovre is given into each affected eye every 25 to 60 days, the frequency that you have your injections will be decided by your physician.

Dose

Only 0.1 mL (15 mg of Syfovre) should be given as a single dose. Any excess volume should be disposed. The injection should be given immediately after the dose has been prepared.

Common side effects of Syfovre include:

• eye discomfort
• wet age-related macular degeneration
• small specks floating in vision
• blood in the white of the eye.

Serious side effects of Syfovre include:

Eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment)

• Call your healthcare provider right away if you have redness of the eye, eye pain, increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small specks floating in your vision, flashes of light, or increased sensitivity to light.

Risk of developing wet AMD. 

• You should be monitored for signs of wet AMD and you should report any symptoms (eg, visual distortion, deterioration in vision, black spots, loss of central vision) to your healthcare provider.

Episodes of eye inflammation. 

• You should report any symptoms (eg, pain or discomfort, redness, swelling, or sensitivity to light, small specks floating in your vision, changes in vision) to your healthcare provider.

Increase in eye pressure within minutes of the injection.

•  Your healthcare provider will monitor this after each injection.

These are not all the possible side effects of this medicine.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.