VABYSMO: The First and Only Dual-Pathway-Inhibiting Therapy in DME and nAMD
Chapter 1: Unmet Needs in nAMD and DME
Chapter 2: Dual Pathway Inhibition With VABYSMO: Ang-2 and VEGF-A
Chapter 3: VABYSMO for Patients With nAMD or DME
Chapter 4: Getting Started With VABYSMO
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) and Diabetic Macular Edema (DME).
Important Safety Information
VABYSMO is contraindicated in patients with ocular or periocular inflammation, 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.
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 during the first year was 2% (25 out of 1,262) in patients treated with VABYSMO compared with 2% (14 out of 625) in patients treated with aflibercept.
The most common adverse reaction (≥5%) reported in patients receiving VABYSMO was conjunctival hemorrhage (7%).
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.
meet the speakers
Rishi P. Singh, MD
Hospital President and
Cleveland Clinic Martin Hospital
Jennifer I. Lim, MD
Marion H. Schenk Esq.,
Chair in Ophthalmology for
Research in the Aging Eye,
Professor of Ophthalmology,
Director of the Retina Service,
University of Illinois at Chicago,
Illinois Eye and Ear Infirmary
in this live broadcast, experts will:
Discuss the role of Ang-2 and VEGF-A in nAMD and DME
Examine Dual-Pathway Inhibition with VABYSMO
Dive into the clinical data supporting VABYSMO’s role in therapy for patients with nAMD or DME