Dual Pathway Inhibition
Study Design, and BCVA and Durability Outcomes of VABYSMO in nAMD: TENAYA & LUCERNE
Drying Effect and Safety of VABYSMO in nAMD: TENAYA & LUCERNE
Patient Selection for VABYSMO and Patient Cases in nAMD from TENAYA & LUCERNE Trials
Study Design, and BCVA and Durability Outcomes of VABYSMO in DME: YOSEMITE & RHINE
Drying Effect and Safety of VABYSMO in DME: YOSEMITE & RHINE
Patient Selection for VABYSMO and Patient Cases in DME from YOSEMITE & RHINE Trials
Dosing of VABYSMO in nAMD and DME
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).
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.
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.
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 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.
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.
The most common adverse reactions (≥5%) reported in patients receiving VABYSMO were cataract (15%) and conjunctival hemorrhage (8%).
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.
CLINICAL PERSPECTIVES PRESENTED BY:
Partner Physician at Georgia Retina
Section Chief of Ophthalmology at Northside Hospital
Retina Group of Washington
Assistant Professor of Ophthalmology
Georgetown University SOM
Orange County Retina
IN THIS ON-DEMAND VIDEO, EXPERTS WILL:
EXAMINE the benefits of dual inhibition of VEGF-A and Ang-2 by VABYSMO in retinal vascular diseases
EVALUATE the vision and anatomic outcomes, and safety profile of VABYSMO observed in phase 3 clinical trials for nAMD and DME
ANALYZE how the durability and drying effect of VABYSMO can potentially benefit patients with nAMD and DME, and discuss its impact on clinical practice