Syfovre
Pronunciation: Sigh-fove-ree
Generic name: pegcetacoplan
Dosage form: intravitreal injection
Drug class: Miscellaneous ophthalmic agents
What is Syfovre?
Syfovre (pegcetacoplan opthalmic) is an FDA-approved treatment for geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD) that can lead to significant vision loss. Syfovre injection helps slow vision loss by targeting an overactive part of the immune system that contributes to retinal damage.
Syfovre is given as an intravitreal injection (injection into the eye), every 25 to 60 days to help manage GA progression and preserve vision. Your retina specialist will numb your eye first with a topical anesthetic, so the injection is not painful but you may feel some pressure during the injection.
- Empaveli, a formulation of pegcetacoplan given by infusion, is used to treat paroxysmal nocturnal hemoglobinuria (PNH).
Geographic atrophy is a progressive and irreversible form of dry age-related macular degeneration (AMD) that damages retinal cells and is a leading cause of blindness. Geographic atrophy lesions start as small damaged areas that gradually 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.
Syfovre approval is for the indication of geographic atrophy secondary to age-related macular degeneration for the company Apellis, on February 17, 2023. Syfovre injection contains the active ingredient pegcetacoplan, which is a complement inhibitor.
How Does Syfovre Work?
Syfovre helps slow the progression of GA by targeting the overactive immune system response that has a damaging effect on the retinal cells
Syfovre mechanism of action is as a complement inhibitor, it inhibits C3, a key protein in the complement system—a part of the immune system that when overactive, damages retinal cells and speeds up GA progression.
By blocking C3, Syfovre injection reduces immune system overactivity, helping to:
- Reduces future damage to retinal cells
- Slow the spread of GA lesions
- Delay vision loss.
How Effective is Syfovre?
Syfovre Clinical Studies: OAKS & DERBY Trials
Syfovre treatment was evaluated in two Phase 3 clinical trials, OAKS and DERBY, which followed 1,258 patients over 24 months to measure its effectiveness in slowing geographic atrophy (GA) progression.
Key Results:
OAKS Trial (637 Participants):
- Monthly Syfovre injections slowed GA lesion growth by 22% (-0.87 mm²/24 months).
- Every-other-month injections slowed lesion growth by 18% (-0.72 mm²/24 months).
DERBY Trial (621 Participants):
- Monthly Syfovre injections slowed lesion growth by 18% (-0.73 mm²/24 months).
- Every-other-month injections slowed lesion growth by 17% (-0.70 mm²/24 months).
Study Design:
- Patients were randomly assigned to receive either Syfovre 15 mg injections or a sham injection (a procedure mimicking the real injection but without active medication).
- Participants ranged in age from 60 to 100 years (average age: 78.7 years).
- At the start of the studies, the average GA lesion size in the affected eye was approximately 8.23 mm² (OAKS) and 8.29 mm² (DERBY).
Syfovre side effects
Common Syfovre side effects
Common side effects of Syfovre are:
- Eye pain, eye irritation, foreign body sensation in eyes, ocular discomfort, abnormal sensation in the eye 13%
- Neovascular age-related macular degeneration 12%
- Seeing flashes of light or "floaters" in your vision (Vitreous floaters)
- Conjunctival bleeding 8%
- Inflammation of the cornea (keratitis) 5%
- Vitreous detachment 4%
- Retinal bleeding 4%
- Posterior capsule opacification 4%
- Intraocular inflammation 4%
- Intraocular pressure increased 2%.
These common side effects occurred in Syfovre patients having monthly injections in the Studies OAKS and DERBY clinical studies, over 24 months.
Serious Syfovre side effects
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.
Other serious side effects
Some other serious side effects may occur right after the injection. Tell your doctor right away if you have:
- signs of eye infection - swelling, severe discomfort, crusting or drainage;
- severe eye redness or pain;
- eyes being more sensitive to light;
- blurred or cloudy vision; or
- changes in your vision, seeing flashes of light.
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 FDA at 1-800-FDA-1088.
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Who should not have this injection?
You should NOT receive this 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
- hypersensitivity to the active ingredient or inactive ingredients.
Warnings and Precautions
- Endophthalmitis and retinal detachments
- Retinal vasculitis and/or retinal vascular occlusion
- Neovascular AMD
- Intraocular inflammation
- Increased intraocular pressure
What should I tell my doctor before receiving this medicine?
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 this medicinemay 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 Syfovre administered?
Syfovre is given as an injection into the vitreous (the soft gel in the middle of your eye) by a qualified physician.
The injection is given into each affected eye every 25 to 60 days; the frequency of your injections will be decided by your physician.
You will need to have frequent eye examinations before and after receiving this injection.
Syfovre J code
Syfovre J code is J2781.
J codes are used for medicines that are not taken orally and include injections, inhalations chemotherapies. J codes are important for accurate and consistent coding for billing and reimbursement purposes.
Your physician will need a Syfovre J-code when filling out forms for your treatment.
Syfovre cost
The cost of this medicine may vary depending on your insurance plan. You may also be eligible for a financial assistance program.
Syfovre dosing information
The usual Adult Dose is 15 mg (0.1 mL of 150 mg/mL solution) given as a single dose. Any excess volume should be disposed of. The injection should be given immediately after the dose has been prepared.
Comments:
- Monitor the patient for elevated intraocular pressure (IOP) using tonometry before and after the intravitreal injection; if needed, ocular hypotensive medication can be given to lower the IOP.
- Administer adequate anesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid, and ocular surface prior to the injection.
- Do not use the filter needle for injection.
- Each vial should only be used for the treatment of a single eye.
What should I avoid while receiving this medicine?
Syfovre 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
- Refrigerate between 2°C to 8°C (36°F to 46°F). Store the vial in the original carton to protect from light.
- Do not use beyond the expiration date on the carton.
- Do not shake.
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.
Syfovre Company
Syfovre Apellis Pharmaceuticals, Inc. 100 Fifth Avenue Waltham, MA 02451
Popular FAQ
How do Izervay and Syfovre compare?
Izervay (avacincaptad pegol) and Syfovre (pegcetacoplan) are injectable treatments for geographic atrophy (GA), a severe form of age-related macular degeneration (AMD) that causes progressive and irreversible vision loss. Continue reading
Is Syfovre covered by Medicare?
Medicare Part B covers eye disease treatment Syfovre if you have geographic atrophy (GA) secondary to age-related macular degeneration (AMD). After you meet your Part B deductible, your cost is 20% of the Medicare-approved amount for the drug and services. Check with your Medicare plan for coverage details. Continue reading
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. Continue reading
References
- Complement C3 Inhibitor Pegcetacoplan for Geographic Atrophy Secondary to Age-Related Macular Degeneration: A Randomized Phase 2 Trial
- Syfovre Package Insert - FDA
- Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials
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Professional resources
- Syfovre Injection prescribing information
- Pegcetacoplan (Geographic Atrophy) (Local) (AHFS Monograph)
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.