Vabysmo (Faricimab)
Bispecific antibody for intravitreal injection — treats wet AMD, diabetic macular edema, and retinal vein occlusion
Vabysmo (faricimab) is the first bispecific antibody approved for intravitreal use in ophthalmology. It simultaneously targets two key proteins — angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A) — to treat neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema from retinal vein occlusion (RVO). Administered by injection into the eye by a specialist, Vabysmo may allow longer intervals between treatments compared to traditional anti-VEGF therapies.
Quick Facts
Key Takeaways
- Vabysmo is the first bispecific antibody for eye diseases, targeting both VEGF-A and Ang-2 to address two complementary pathways of retinal vascular disease.
- It is approved for wet age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema from retinal vein occlusion (RVO) in adults.
- Treatment intervals can be extended up to every 16 weeks (4 months) after an initial loading phase, potentially reducing treatment burden compared to monthly injections.
- The most common side effects are eye-related, including cataract, conjunctival hemorrhage, increased eye pressure, and floaters — most are mild and temporary.
- Vabysmo must be administered by a qualified ophthalmologist under sterile conditions and is not suitable for use during pregnancy or breastfeeding without careful medical evaluation.
What Is Vabysmo and What Is It Used For?
Vabysmo contains the active substance faricimab, which belongs to a class of medicines called anti-neovascular agents. It is a bispecific antibody, meaning it is engineered to simultaneously bind and neutralize two distinct biological targets. This innovative dual-action mechanism sets Vabysmo apart from earlier generation anti-VEGF treatments that target only a single protein.
Vabysmo is injected into the vitreous cavity of the eye (intravitreal injection) by a trained ophthalmologist to treat adults with the following conditions:
- Neovascular (wet) age-related macular degeneration (nAMD): A progressive condition where abnormal blood vessels grow beneath the retina and leak blood and fluid into the macula, the central part of the retina responsible for sharp central vision. Wet AMD is the leading cause of severe vision loss in adults over 50 in developed countries.
- Diabetic macular edema (DME): A complication of diabetes mellitus where chronically high blood sugar damages the small blood vessels of the retina, causing them to leak fluid into the macula. DME is the most common cause of vision loss in people with diabetes and affects approximately 7% of diabetic patients worldwide.
- Macular edema due to retinal vein occlusion (RVO): Blockage of one or more veins that drain blood from the retina leads to increased pressure, causing fluid to leak into the macula. RVO includes both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO), and is the second most common retinal vascular disorder after diabetic retinopathy.
How Does Vabysmo Work?
Vabysmo specifically recognizes and blocks two proteins: angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A). When these proteins are present at higher-than-normal levels in the eye, they can cause growth of abnormal blood vessels and damage to normal blood vessels. This leads to fluid leakage into the macula, causing swelling and vision impairment.
By binding to both VEGF-A and Ang-2 simultaneously, Vabysmo addresses two complementary disease pathways. VEGF-A inhibition reduces vascular permeability (leakage) and new blood vessel formation. Ang-2 inhibition helps stabilize blood vessel walls, reduce inflammation, and improve overall vascular integrity. Together, these actions can reduce macular swelling, prevent further vascular damage, and improve or preserve visual acuity.
Clinical evidence from the phase III TENAYA and LUCERNE trials (for nAMD) and the YOSEMITE and RHINE trials (for DME) demonstrated that Vabysmo provided vision gains comparable to aflibercept (Eylea), with many patients achieving extended treatment intervals of up to 16 weeks. The BALATON and COMINO trials further established Vabysmo’s efficacy in RVO. These pivotal studies formed the basis for regulatory approvals by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
What Should You Know Before Receiving Vabysmo?
Contraindications
You should not receive Vabysmo if any of the following apply to you:
- Allergy to faricimab or any of the other ingredients in Vabysmo (L-histidine, acetic acid, L-methionine, sodium chloride, sucrose, polysorbate 20, or water for injections).
- Active or suspected infection in or around the eye (ocular or periocular infection).
- Active eye inflammation (intraocular inflammation), such as eye pain or significant redness.
If any of these conditions apply to you, inform your ophthalmologist before treatment. You should not receive Vabysmo until the infection or inflammation has resolved.
Warnings and Precautions
Talk to your doctor before receiving Vabysmo if you:
- Have glaucoma (a condition often caused by elevated intraocular pressure).
- Have previously experienced flashes of light or floaters (dark spots that drift across your vision), or if these have suddenly increased in number or size.
- Have had eye surgery within the past four weeks or have eye surgery planned in the coming four weeks.
- Have a history of any other eye disease or eye treatment.
- Sudden decrease or change in vision
- Increasing eye redness, pain, or discomfort
- Blurred or worsening vision
- Increased number of small particles (floaters) in your vision
- Increased sensitivity to light
These may be signs of a serious eye infection (endophthalmitis), inflammation, retinal detachment, or an allergic reaction that requires immediate treatment.
Important safety information:
- The safety and efficacy of Vabysmo administered simultaneously in both eyes has not been studied and may carry an increased risk of adverse effects.
- Intravitreal injections of Vabysmo may temporarily increase intraocular pressure (IOP) in some patients within 60 minutes of the injection. Your doctor will monitor your IOP after each treatment.
- Your ophthalmologist will assess whether you have risk factors for retinal tears or detachment, or pigment epithelial tears or detachment. If so, Vabysmo should be used with caution.
- There is a known risk, with medicines that work similarly to Vabysmo, of blood clots blocking blood vessels (arterial thromboembolic events), which could lead to heart attack or stroke. While only small amounts of the drug enter the bloodstream, there is a theoretical risk of such events after intravitreal injection.
- Patients with active infections
- Patients aged 85 years or older with nAMD or RVO
- Patients with DME caused by type 1 diabetes
- Diabetic patients with HbA1c above 10%
- Diabetic patients with proliferative diabetic retinopathy
- Diabetic patients with uncontrolled hypertension (above 140/90 mmHg)
- Patients receiving injections more frequently than every 8 weeks for extended periods
Pregnancy and Breastfeeding
Vabysmo has not been studied in pregnant women. Because it inhibits VEGF-A, which plays a role in fetal development and placental function, Vabysmo should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the fetus. Women of childbearing potential must use effective contraception during treatment and for at least 3 months after the last dose of Vabysmo.
It is not known whether faricimab passes into breast milk. Breastfeeding is not recommended during Vabysmo treatment. If you are pregnant, breastfeeding, think you may be pregnant, or are planning a pregnancy, discuss your options with your ophthalmologist before receiving this medicine.
Children and Adolescents
The use of Vabysmo in children and adolescents under 18 years has not been studied, as nAMD, DME, and RVO are conditions that predominantly occur in adults.
Driving and Operating Machinery
Temporary visual disturbances (such as blurred vision) may occur after Vabysmo injection. Do not drive or operate machinery until these symptoms have fully resolved, which typically occurs within a few hours after treatment.
How Does Vabysmo Interact with Other Drugs?
Vabysmo is administered by intravitreal injection, meaning it is delivered directly into the vitreous cavity of the eye. The systemic exposure following intravitreal injection is very low, with peak serum concentrations of faricimab approximately 200-fold lower than the concentrations achieved within the eye. Because of this local delivery route and minimal systemic absorption, clinically meaningful pharmacokinetic drug interactions with systemically administered medicines are not expected.
No formal drug interaction studies have been conducted with Vabysmo. However, based on its mechanism of action and route of administration, the following considerations apply:
| Drug / Class | Interaction Type | Clinical Significance |
|---|---|---|
| Other intravitreal anti-VEGF agents (ranibizumab, aflibercept, bevacizumab, brolucizumab) | Additive pharmacological effect | Should not be used concurrently in the same eye. Switching between agents should follow clinical guidelines with appropriate washout. |
| Intravitreal corticosteroids (dexamethasone implant, triamcinolone) | Potential additive effect on IOP | Combined use may increase risk of elevated intraocular pressure. Monitor IOP closely if co-administered. |
| Topical ocular medications (e.g., glaucoma drops, NSAIDs) | No known pharmacokinetic interaction | Continue as prescribed. Inform ophthalmologist of all topical eye drops used. |
| Systemic anticoagulants / antiplatelets (warfarin, aspirin, clopidogrel, DOACs) | Theoretical increased bleeding risk | May increase risk of conjunctival or vitreous hemorrhage following injection. Generally not required to discontinue prior to injection, but discuss with your doctor. |
| Systemic VEGF-targeted therapies (bevacizumab IV, ramucirumab) | Theoretical additive anti-VEGF effect | Patients receiving systemic anti-VEGF therapy for cancer treatment should be monitored closely for systemic anti-VEGF side effects. Discuss with both oncologist and ophthalmologist. |
Always inform your ophthalmologist about all medicines you are currently taking, have recently taken, or plan to take, including prescription medications, over-the-counter drugs, eye drops, and supplements. This is particularly important if you are receiving any other eye treatments or systemic therapies that affect blood vessel function.
What Is the Correct Dosage of Vabysmo?
Vabysmo is always administered by a qualified ophthalmologist experienced in intravitreal injections. The standard dose for all approved indications is 6 mg faricimab (0.05 mL of the 120 mg/mL solution), delivered as a single intravitreal injection per treatment session.
Wet Age-Related Macular Degeneration (nAMD)
nAMD Dosing Schedule
- Loading phase: One injection per month for the first 3 months (weeks 0, 4, and 8).
- Maintenance phase: Injection intervals are then adjusted based on disease activity assessed by the treating physician. Intervals may be extended in 4-week increments up to a maximum of every 16 weeks (4 months).
- If disease activity worsens, the interval may be shortened accordingly.
Diabetic Macular Edema (DME)
DME Dosing Schedule
- Loading phase: One injection per month for at least 3 months (weeks 0, 4, and 8).
- Maintenance phase: Injection intervals may be extended based on disease activity. The physician adjusts intervals in 4-week increments, with a potential maximum interval of up to every 16 weeks.
- Some patients may require continued monthly injections if their disease does not adequately respond to extended intervals.
Retinal Vein Occlusion (RVO)
RVO Dosing Schedule (BRVO and CRVO)
- Loading phase: One injection per month for at least 3 months.
- Maintenance phase: Injection intervals may be extended based on disease activity, as determined by the physician.
How Vabysmo Is Administered
Vabysmo is injected into the vitreous cavity of the eye under aseptic conditions by an experienced ophthalmologist. Before the injection, your doctor will carefully clean the eye with antiseptic solution to prevent infection, and administer local anesthetic eye drops to numb the eye and minimize discomfort during the procedure. The injection itself takes only a few seconds.
Each Vabysmo vial is for single use only and contains sufficient volume to deliver the 0.05 mL dose. The vial contents are drawn up using a sterile filter needle (included in the package), then transferred to a sterile injection syringe fitted with a 30-gauge needle for the actual injection. Any excess solution is discarded.
Missed Dose
If you miss a scheduled appointment for your Vabysmo injection, contact your ophthalmologist’s office as soon as possible to reschedule. Missing doses can allow your condition to worsen and lead to further vision loss. Your doctor will assess your eye at the rescheduled visit and determine the appropriate treatment plan going forward.
Stopping Treatment
Do not stop treatment without discussing it with your doctor. Discontinuing Vabysmo prematurely may result in disease recurrence, progressive macular damage, and irreversible vision loss. If you have concerns about your treatment, speak with your ophthalmologist who can discuss the benefits and risks of continuing therapy.
Vabysmo treatment for nAMD, DME, and RVO is typically long-term and may continue for months or years. Your ophthalmologist will regularly monitor your condition with eye examinations and imaging to ensure the treatment is working effectively and to adjust the injection interval as needed.
What Are the Side Effects of Vabysmo?
Like all medicines, Vabysmo can cause side effects, although not everyone experiences them. Side effects may result from either the medication itself or from the injection procedure, and they predominantly affect the treated eye. Most side effects are mild to moderate in severity and generally resolve within one week of the injection.
Eye pain, increasing discomfort, worsening redness, blurred or decreased vision, increased floaters, or light sensitivity. These may indicate a serious infection (endophthalmitis), inflammation, or retinal detachment requiring urgent treatment. A sudden deterioration or change in vision also requires immediate medical attention.
Common
May affect up to 1 in 10 people
- Cataract (clouding of the eye lens)
- Retinal pigment epithelium tear (in nAMD patients only)
- Vitreous detachment (separation of the gel-like substance inside the eye)
- Increased intraocular pressure (elevated eye pressure)
- Conjunctival hemorrhage (bleeding from small blood vessels on the eye surface)
- Vitreous floaters (moving spots or dark shadows in the field of vision)
- Eye pain
Uncommon
May affect up to 1 in 100 people
- Endophthalmitis (serious infection inside the eye)
- Vitritis (inflammation of the vitreous) / red eye
- Uveitis, iritis, iridocyclitis (inflammation of eye structures)
- Vitreous hemorrhage (bleeding inside the eye)
- Eye discomfort and eye irritation
- Eye itching (ocular pruritus)
- Retinal tear or retinal detachment
- Conjunctival hyperemia (red eye)
- Foreign body sensation in the eye
- Blurred vision and decreased visual acuity
- Injection site pain
- Increased lacrimation (tearing)
- Corneal abrasion (scratch on the eye surface)
Rare
May affect up to 1 in 1,000 people
- Transient decreased visual acuity (temporary vision reduction)
- Traumatic cataract (lens clouding from injury during injection)
Not Known
Frequency cannot be estimated from available data
- Retinal vasculitis (inflammation of blood vessels at the back of the eye)
- Retinal occlusive vasculitis (blockage of retinal blood vessels), commonly associated with inflammation
As with other medicines that inhibit VEGF, there is a known class-wide risk of arterial thromboembolic events (blood clots that can cause heart attack or stroke). Although only very small amounts of faricimab reach the systemic circulation, a theoretical risk of such events exists following intravitreal injection. Patients with a history of cardiovascular disease should discuss this risk with their doctor.
If you experience any side effect, including those not listed here, talk to your doctor. You can also report suspected side effects to your national pharmacovigilance authority (e.g., FDA MedWatch in the United States, the Yellow Card scheme in the United Kingdom, or the EMA in Europe). Reporting side effects helps monitor the ongoing benefit-risk balance of medicines.
How Should You Store Vabysmo?
As Vabysmo is administered by healthcare professionals in a clinical setting, storage and handling are typically managed by your ophthalmologist’s office or hospital pharmacy. However, understanding storage requirements can be helpful for ensuring medication quality.
- Temperature: Store in a refrigerator at 2°C to 8°C (36°F to 46°F).
- Do not freeze. Frozen product must be discarded.
- Light protection: Keep the vial in the outer carton to protect from light.
- Room temperature storage: The unopened vial may be kept at room temperature (20°C to 25°C / 68°F to 77°F) for up to 24 hours before use.
- Expiry date: Do not use after the expiry date printed on the carton and label (EXP). The expiry date refers to the last day of the stated month.
- Keep out of reach of children.
The vial is for single use only. Any unused portion of the solution must be discarded after the injection, as Vabysmo does not contain preservatives. Healthcare facilities are responsible for disposing of unused medicine in accordance with local waste disposal requirements.
What Does Vabysmo Contain?
Active Ingredient
The active substance is faricimab. Each milliliter of solution contains 120 mg of faricimab. Each single-use glass vial contains 28.8 mg of faricimab in 0.24 mL of solution, providing a sufficient volume to deliver a single dose of 0.05 mL containing 6 mg of faricimab.
Inactive Ingredients (Excipients)
The other ingredients in Vabysmo are:
- L-histidine — buffer to maintain pH
- Acetic acid (30%) (E 260) — pH adjustment
- L-methionine — antioxidant stabilizer
- Sodium chloride — tonicity agent
- Sucrose — stabilizer
- Polysorbate 20 (E 432) — surfactant (0.02 mg per 0.05 mL dose)
- Water for injections — solvent
Vabysmo contains less than 1 mmol (23 mg) sodium per dose, making it essentially “sodium-free.” The polysorbate content (0.02 mg per dose) is very low but may potentially cause allergic reactions in sensitive individuals. Tell your doctor if you have known allergies to polysorbates.
Appearance and Packaging
Vabysmo is a clear to opalescent, colorless to brownish-yellow sterile solution. Each package contains one single-use glass vial and one blunt-tip, filter-equipped transfer needle (18 G x 1½ inch, 1.2 mm x 40 mm, 5 µm filter). The injection syringe (1 mL Luer Lock) and injection needle (30 G x ½ inch) are not included and must be supplied separately.
Vabysmo is manufactured by Roche Pharma AG, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany, and the marketing authorization holder is Roche Registration GmbH.
Frequently Asked Questions About Vabysmo
Vabysmo (faricimab) is an intravitreal injection used to treat three eye conditions in adults: neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema caused by retinal vein occlusion (RVO), which includes both branch and central retinal vein occlusion. It works by blocking two proteins (VEGF-A and Ang-2) that drive abnormal blood vessel growth and leakage in the retina, thereby reducing swelling and preserving or improving vision.
Treatment starts with monthly injections for the first 3 months (loading phase). After that, the interval between injections may be extended up to every 16 weeks (4 months), depending on how well your eye responds to treatment. Your ophthalmologist will determine the ideal schedule based on regular eye examinations, including optical coherence tomography (OCT) imaging. Some patients may be able to maintain long treatment intervals, while others may need more frequent injections.
The most frequently reported side effects include cataract, conjunctival hemorrhage (bleeding on the white of the eye), increased intraocular pressure, vitreous detachment, vitreous floaters (dark spots or shadows in vision), and eye pain. These are generally mild to moderate and resolve within a week after each injection. Serious side effects such as endophthalmitis (severe eye infection), retinal detachment, and retinal vasculitis are uncommon to rare but require immediate medical attention.
Vabysmo is the first and currently only bispecific antibody approved for ophthalmic use. While other anti-VEGF treatments like ranibizumab (Lucentis), aflibercept (Eylea), and brolucizumab (Beovu) target only VEGF-A (or VEGF-A and VEGF-B in the case of aflibercept), Vabysmo simultaneously inhibits both VEGF-A and angiopoietin-2 (Ang-2). Ang-2 contributes to vascular instability, inflammation, and new blood vessel formation through a separate pathway. This dual mechanism may allow for more durable treatment responses and longer intervals between injections — with many patients achieving 12- to 16-week dosing intervals in clinical trials.
Vabysmo has not been studied in pregnant women and is not recommended during pregnancy unless the potential benefit to the mother outweighs the risk to the fetus. Because it inhibits VEGF-A, which is critical for normal fetal development and placental function, there is a theoretical risk of harm. Women of childbearing potential must use effective contraception during treatment and for at least 3 months following the last injection. Breastfeeding is not recommended during treatment, as it is unknown whether faricimab passes into breast milk.
Clinical trials have demonstrated that Vabysmo can both improve and maintain visual acuity. In the TENAYA and LUCERNE trials (nAMD), patients gained an average of approximately 5-6 letters of visual acuity at one year. In the YOSEMITE and RHINE trials (DME), average gains were approximately 10-11 letters. In the BALATON (BRVO) and COMINO (CRVO) trials, substantial vision improvements were also observed. Early initiation of treatment is associated with better outcomes. However, individual responses vary, and some patients may primarily experience stabilization rather than improvement of their existing vision.
References
This article is based on the following evidence-based sources. All medical claims are supported by Level 1A evidence (systematic reviews and randomized controlled trials) or authoritative regulatory documents.
- European Medicines Agency (EMA). Vabysmo (faricimab) — Summary of Product Characteristics. EMA/H/C/005765. Last updated 2025. Available at: ema.europa.eu
- U.S. Food and Drug Administration (FDA). VABYSMO (faricimab-svoa) — Prescribing Information. Reference ID: 4938785. Genentech, Inc. Available at: FDA Drug Labels
- Heier JS, Khanani AM, Quezada Ruiz C, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, non-inferiority, phase 3 trials. Lancet. 2022;399(10326):729-740. doi:10.1016/S0140-6736(22)00010-1
- Wykoff CC, Abreu F, Adamis AP, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, non-inferiority, phase 3 trials. Lancet. 2022;399(10326):741-755. doi:10.1016/S0140-6736(22)00018-6
- Tadayoni R, Sararols L, Weissgerber G, et al. Efficacy and safety of faricimab for macular edema due to retinal vein occlusion: 24-week results from the BALATON and COMINO trials. Ophthalmology. 2024;131(8):950-960. doi:10.1016/j.ophtha.2024.02.014
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List, 2023. Geneva: WHO; 2023.
- American Academy of Ophthalmology (AAO). Preferred Practice Pattern: Age-Related Macular Degeneration. 2023 Update. San Francisco: AAO; 2023.
- Schmidt-Erfurth U, Garcia-Arumi J, Bandello F, et al. Guidelines for the management of diabetic macular edema by the European Society of Retina Specialists (EURETINA). Ophthalmologica. 2017;237(4):185-222. doi:10.1159/000458539
About Our Medical Editorial Team
This article has been written and reviewed by iMedic’s medical editorial team, consisting of licensed physicians and pharmacologists with expertise in ophthalmology, retinal diseases, and clinical pharmacology. Our content follows international medical guidelines and the GRADE evidence framework.
All medical information is based on peer-reviewed research, international guidelines (EMA, FDA, AAO, EURETINA), and systematic reviews. Evidence Level 1A.
This article is reviewed and updated regularly to reflect the latest clinical evidence, regulatory changes, and treatment guidelines.
iMedic receives no pharmaceutical company funding. Our editorial independence ensures unbiased medical information.
This page complies with WCAG 2.2 Level AAA standards, ensuring medical information is accessible to all users regardless of ability.