Pegcetacoplan eye injections
Pronunciation: peg-SET-a-KOE-plan
Generic name: pegcetacoplan ophthalmic
Brand name: Syfovre
Dosage form: intravitreal injection (15 mg/0.1 mL)
Drug class: Miscellaneous ophthalmic agents
What is pegcetacoplan?
Intravitreal pegcetacoplan (Syfovre) is used to treat geographic atrophy (GA), the dry, advanced form of age-related macular degeneration (AMD). It is given as an injection into each affected eye by a qualified healthcare provider every 25 to 60 days.
Pegcetacoplan for injection into the eye gained FDA approval on February 17, 2023, under the brand name Syfovre. It is manufactured by Apellis Pharmaceuticals Inc. There is no generic.
- A formulation of pegcetacoplan given by infusion (Empaveli) is used to treat paroxysmal nocturnal hemoglobinuria (PNH).
How does intravitreal pegcetacoplan work?
Pegcetacoplan works by targeting an overactive immune response that can harm cells in the retina. It focuses on a protein called C3 which is part of the complement system - an immune system component that, when too active, can damage retinal cells and accelerate GA progression.
By inhibiting the C3 protein, intravitreal pegcetacoplan helps:
- Protect retinal cells from further immune system damage
- Reduce the expansion of GA lesions in the eye
- Help preserve vision for a longer period by slowing disease progression.
Pegcetacoplan belongs to the drug class called complement inhibitors.
How effective is intravitreal pegcetacoplan?
Clinical trials, including two Phase 3 clinical trials, OAKS and DERBY, which followed 1,258 patients over 24 months reported:
- Slowing of GA lesions by 18 to 22% (-0.72 mm² to -0.87 mm²/24 months) with monthly pegcetacoplan injections
- Slowing of GA lesions by 17 to 18% (-0.70 mm² to -0.72 mm²/24 months) with pegcetacoplan injections every 2 months.
Pegcetacoplan side effects
The most common side effects of pegcetacoplan injections into the eye are:
- Eye discomfort, such as pain, irritation, or a feeling that something is in your eye
- Development of wet macular degeneration
- Seeing flashes of light or "floaters" in vision (vitreous floaters)
- Minor eye bleeding (conjunctival bleeding)
- Inflammation of the cornea (clear outer layer at the front of the eye) and other parts of the eye
- Vitreous detachment (when a gel-like substance within the eye separates from the retina)
- Retinal bleeding
- Clouding of the eye’s lens capsule (posterior capsule opacification)
- Increased eye pressure.
Serious pegcetacoplan injection side effects
Intravitreal pegcetacoplan can cause the following serious side effects.
Eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment). Call your healthcare provider right away if you have eye redness, light sensitivity, eye pain, or any change in vision including blurred, wavy/distorted vision, small specks floating in your vision, or flashing lights.
Severe inflammation of the vessels in the retina that may result in severe vision loss. Call your healthcare provider right away if you have eye redness, light sensitivity, eye pain, or any change in vision including blurred, wavy/distorted vision, or flashing lights
Risk of developing wet AMD. You should be monitored for signs of wet AMD and you should report if you have any change in vision including blurred, wavy/distorted vision, black spots, or loss of central vision to your healthcare provider.
Episodes of eye inflammation. You should report any symptoms including eye redness, light sensitivity, eye pain, specks floating in your vision, or any 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.
Allergic reactions: Get emergency medical help if you have signs of an allergic reaction with symptoms of hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Before receiving
Do NOT receive a pegcetacoplan injection 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
- are allergic to the active ingredient or inactive ingredients.
Before receiving this medicine, tell your healthcare provider about all your medical conditions, including if you:
- Have a history of seeing flashes of light or specks floating in your vision and notice a sudden increase in the size and number of these specks
- Have high pressure in the eye or glaucoma
- Are pregnant or planning to become pregnant
- Are breastfeeding or planning to breastfeed.
Pregnancy
Females who can become pregnant should use effective contraception methods to prevent pregnancy during treatment with this medicine and for 40 days after the last dose. The use of this medicine 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 breastfeed, your doctor will talk to you about the best way to feed your baby.
How is pegcetacoplan administered?
Pegcetacoplan is given as an injection into the soft gel (vitreous) in the middle of your eye by a qualified healthcare provider. This is called an intravitreal injection.
- The injection is given into each affected eye 1 time every 25 to 60 days.
- Your healthcare provider will decide how often you receive your injections.
You will need frequent eye examinations before and after receiving this injection.
Pegcetacoplan dosing information
Before giving you the eye injection, your healthcare provider will numb (anesthetize) your eye and use a broad-spectrum antibiotic eye drop to disinfect the periocular skin, eyelid, and ocular surface prior to the injection.
Adult Dose for GA caused by AMD: Pegcetacoplan 15 mg (0.1 mL of a 150 mg/mL solution).
- Administer a single dose into each affected eye.
- Dispose of any excess volume.
After the eye injection
- Your healthcare provider will monitor you for any increase in eye pressure.
What should I avoid while receiving this medicine?
Pegcetacoplan injection may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.
Storage
Your healthcare provider will store pegcetacoplan in the refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
- The vial should not be shaken or used beyond the expiration date on the carton.
What other drugs will affect this medicine?
Medicine used in the eyes is not likely to be affected by other drugs you use. But many drugs can interact. Tell your doctor about all your current medicines, including prescription and over-the-counter medicines, vitamins, and herbal products.
Who makes pegcetacoplan?
Intravitreal pegcetacoplan is made by Apellis Pharmaceuticals, Inc., under the brand name Syfovre.
This company is based in Waltham, MA 02451 and also makes Empaveli, a formulation of pegcetacoplan that is given as an infusion and used to treat paroxysmal nocturnal hemoglobinuria (PNH).
References
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- Drug class: miscellaneous ophthalmic agents
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