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CLINICAL TRIAL DATA

VABYSMO VIEWPOINTS

What determines your go-to treatment in clinical practice?

Join Dr. Veeral Sheth and Dr. Katherine Talcott as they discuss their real-world experiences with VABYSMO, and explore how factors spanning mechanism of action, efficacy, and access come together to determine their go-to treatment.

"VABYSMO is my treatment of choice for all approved indications – nAMD, DME, and RVO. I am excited to offer my patients VABYSMO as early as possible to help optimize their outcomes."

Dr. Nik London
Retina Consultants San Diego

"VABYSMO’s ability to rapidly dry the retina is truly impressive.* I've witnessed its impact on patients with nAMD, DME, and RVO in my own clinic, making it my preferred treatment option."

Dr. Harit Bhatt
University Retina

*Reductions in CST over time were prespecified secondary endpoints. Reductions in CST were observed across all treatment arms throughout the six Phase 3 studies in nAMD, DME, and RVO.¹ See additional information on the Drying page.

PODCASTS

From Trials to the Clinic: Using a Therapy With a Novel MOA to Treat Patients With DME

Moderator: Dr. John Kitchens
Speakers: Dr. Maria Berrocal

One of the challenges associated with current anti-VEGF therapies for the management of DME is the need for frequent injections and the potential impact on adherence and vision outcomes. Join Dr. John Kitchens and Dr. Maria Berrocal as they share their experiences treating their DME patients using a therapy with a novel mechanism of action, and how those patient outcomes have influenced their extension decisions and treatment management approaches. This special episode of New Retina Radio, and its content, is supported by Genentech USA, Inc.

A Treatment With a Novel MOA for Patients With nAMD and DME: Perspectives From the Real World

Moderator: Dr. John Kitchens 
Speakers: Dr. David Chin Yee & Dr Margaret Chang

Recent studies have proven the therapeutic viability of a different approach in treating retinal vascular diseases. Join Dr. John Kitchens, Dr. Margaret Chang, and Dr. David Chin Yee as they discuss their clinical experiences using a therapy with a novel mechanism of action in patients with nAMD and DME. And, learn how they approach managing patients with macular edema. This special episode of New Retina Radio, and its content, is supported by Genentech USA, Inc.

“As retina specialists, we feel very confident when we're using VABYSMO, particularly when we use VABYSMO right out of the gates. We can see its drying impact on the patient's OCT.^†”

Dr. Krishna Mukkamala
Georgia Retina

"Based on many successes, it has now become my first choice for treatment-naive patients with DME, nAMD, and RVO."

Dr. Daniel Learned
California Retina Consultants

^†Reductions in CST over time were prespecified secondary endpoints. Reductions in CST were observed across all treatment arms throughout the six Phase 3 studies in nAMD, DME, and RVO.¹ See additional information on the Drying page.

CLINICAL TRIAL DATA

Explore key trial results and patient cases with the experts

CST=central subfield thickness; DME=diabetic macular edema; MOA=mechanism of action; nAMD=neovascular age-related macular degeneration; OCT=optical coherence tomography; RVO=retinal vein occlusion.

DRYING

Explore drying data across all 3 indications

THE ACCESS YOU NEED
FOR THE DOSING THEY NEED

When dosing needs change, access doesn’t have to

INDICATIONS
VABYSMO (faricimab-svoa) is a vascular endothelial growth factor (VEGF) inhibitor and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), and Macular Edema following Retinal Vein Occlusion (RVO).

IMPORTANT SAFETY INFORMATION

Contraindications
VABYSMO is contraindicated in patients with ocular or periocular infection, in patients with active intraocular inflammation, and in patients with known hypersensitivity to faricimab or any of the excipients in VABYSMO. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation.

Warnings and Precautions
Endophthalmitis and Retinal Detachments
Intravitreal injections have been associated with endophthalmitis and retinal detachments. Proper aseptic injection techniques must always be used when administering VABYSMO. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management.

Increase in Intraocular Pressure
Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injection, including with VABYSMO. IOP and the perfusion of the optic nerve head should be monitored and managed appropriately.

Thromboembolic Events
Although there was a low rate of arterial thromboembolic events (ATEs) observed in the VABYSMO clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).

The incidence of reported ATEs in the nAMD studies during the first year was 1% (7 out of 664) in patients treated with VABYSMO compared with 1% (6 out of 662) in patients treated with aflibercept.

The incidence of reported ATEs in the DME studies from baseline to week 100 was 5% (64 out of 1,262) in patients treated with VABYSMO compared with 5% (32 out of 625) in patients treated with aflibercept.

The incidence of reported ATEs in the RVO studies during the first 6 months was 1.1% (7 out of 641) in patients treated with VABYSMO compared with 1.4% (9 out of 635) in patients treated with aflibercept.

Retinal Vasculitis and/or Retinal Vascular Occlusion
Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of VABYSMO. Healthcare providers should discontinue treatment with VABYSMO in patients who develop these events. Patients should be instructed to report any change in vision without delay.

Adverse Reactions
The most common adverse reactions (≥5%) reported in patients receiving VABYSMO were cataract (15%) and conjunctival hemorrhage (8%).

Pregnancy, Lactation, Females and Males of Reproductive Potential
Based on the mechanism of action of VEGF and Ang-2 inhibitors, there is a potential risk to female reproductive capacity, and to embryo-fetal development. VABYSMO should not be used during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VABYSMO and any potential adverse effects on the breastfed child from VABYSMO. Females of reproductive potential are advised to use effective contraception prior to the initial dose, during treatment and for at least 3 months following the last dose of VABYSMO.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in the full VABYSMO Prescribing Information.

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