FDA Approves Genentech’s Bispecific Antibody For Two Leading Causes Of Vision Loss

January 28th, 2022

On January 28, 2022, the FDA approved Vabysmo^™ (faricimab-svoa) for the treatment of people with wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Vabysmo is the only injectable eye medicine approved simultaneously in the U.S. for wet AMD and DME, with flexible dosing regimens based on patient need.

News in brief

• Vabysmo is the first bispecific antibody approved to treat eye conditions.
• It targets and inhibits angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) – two disease pathways linked to a number of vision-threatening retinal conditions.
• The approval is based on positive results across four Phase III studies in wet AMD and DME.
• Vabysmo is the first and only FDA-approved injectable eye medicine for wet AMD and DME that improves and maintains vision with treatments from one to four months apart in the first year following four initial monthly doses, based on evaluation of the patient’s anatomy and vision outcomes. Standard of care for wet AMD and DME typically requires eye injections every one to two months.

Supporting Information

Important Safety Information

Do not receive VABYSMO if you:

• have an infection in or around your eye.
• have active swelling around your eye that may include pain and redness.
• are allergic to VABYSMO or any of the ingredients in VABYSMO.

What is the most important information I should know about VABYSMO?

• Injections like the one for VABYSMO can cause an eye infection (endophthalmitis) or separationof layers of the retina (retinal detachment). Call your healthcare provider right away if you have increasing eye pain, vision loss, sensitivity to light, or redness in the white of the eye.
• VABYSMO may cause a temporary increase in pressure in the eye (intraocular pressure), which occurs within 60 minutes after receiving the eye injection.
• Although not common, VABYSMO patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes (thromboembolic events). In clinical studies forwet AMD during the first year, 7 out of 664 patients treated with VABYSMO reported such an event. In DME studies from baseline to week 100, 64 out of 1,262 patients treated with VABYSMO reported such an event.

Before receiving VABYSMO, tell your healthcare provider about all of your medical conditions, including if you:

• Are pregnant or plan to become pregnant. Based on how VABYSMO interacts with your body,there may be a potential risk to your unborn baby. You should use birth control before your first injection, during your treatment with VABYSMO, and for 3 months after your last dose of VABYSMO.
• Are breastfeeding or plan to breastfeed. It is not known if VABYSMO passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you receive VABYSMO.
• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while receiving VABYSMO?

• Your vision may be impaired after receiving an eye injection or after an eye exam; do not drive or use machinery until your vision has recovered sufficiently.

What are the most common side effects with VABYSMO?

• The most common side effects with VABYSMO were cataract and blood on the white of the eye (conjunctival hemorrhage).
• These are not all the possible side effects of VABYSMO.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.

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

Revised 27 Jan 2023