Vabysmo is a type of biological drug called a bispecific antibody. It is used to treat eye disease and is injected into the eyes.

Vabysmo helps to stop the growth of unstable blood vessels in your eyes. These abnormal blood vessels contribute to the development of certain eye diseases.

Vabysmo works by binding to both vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2). VEGF-A and Ang-2 are proteins that are overproduced in some people with eye disease.

Too much VEGF-A causes abnormal, leaky blood vessels to grow, causing damage to your macula. The macula is the part of your retina at the back of your eye and it is responsible for your central vision. Too much Ang-2 causes blood vessels to become unstable, causing them to leak, the area to become inflamed and new blood vessels to grow.

Vabysmo is the first bispecific antibody to be approved for treating eye disorders. It was approved by the US Food and Drug Administration (FDA) in early 2022.

What is Vabysmo used for?

Vabysmo is a prescription medicine used to treat adults with neovascular (wet) age related macular degeneration (AMD) and diabetic macular edema (DME).

• Injections like the one for Vabysmo can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment). Call your healthcare provider right away if you have:
  • increasing eye pain
  • vision loss
  • sensitivity to light
  • redness in the white of the eye
• Vabysmo may cause a temporary increase in pressure in the eye (intraocular pressure), which occurs 60 minutes after the 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 for wet AMD during the first year, 7 out of 664 patients treated with Vabysmo reported such an event. In DME studies during the first year, 25 out of 1,262 patients treated with Vabysmo reported such an event.

• Vabysmo is administered by a healthcare professional.
• Vabysmo is given by injection into your eye(s). A separate syringe will be used for each eye.
• Vabysmo will be injected slowly until the rubber stopper on the syringe reaches the end and a volume of 0.05 ml is administered.
• Immediately after Vabysmo is administered you will be monitored to check for elevation in your intraocular pressure - the fluid pressure in your eye.
• Vabysmo is initially given every 4 weeks for the first 4-6 doses and then as advised by your healthcare professional.

• Neovascular (wet) AMD
  The recommended dose for Vabysmo is 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly) for the first 4 doses. This should be followed by optical coherence tomography and visual acuity evaluations 8 and 12 weeks later to inform whether to give a 6 mg dose via intravitreal injection on one of the following three regimens:
  • 1) Weeks 28 and 44:
  • 2) Weeks 24, 36 and 48; or
  • 3) Weeks 20, 28, 36 and 44.
    Some patients may need every 4 week (monthly) dosing after the first 4 doses.
• DME
  Vabysmo is recommended to be dosed by following one of these two dose regimens:
  • 1) 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days ± 7 days, monthly) for at least 4 doses. If after at least 4 doses, resolution of edema based on the central subfield thickness (CST) of the macula as measured by optical coherence tomography is achieved, then the interval of dosing may be modified by extensions of up to 4 week interval increments or reductions of up to 8 week interval increments based on CST and visual acuity evaluations through week 52; or
  • 2) 6 mg dose of Vabysmo can be administered every 4 weeks for the first 6 doses, followed by 6 mg dose via intravitreal injection at intervals of every 8 weeks (2 months) over the next 28 weeks.
    Some patients may need every 4 week (monthly) dosing after the first 4 doses. Patients should be assessed regularly.

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. See below for a complete list of ingredients in Vabysmo.

What should I tell my doctor before receiving Vabysmo?

Before receiving Vabysmo, tell your healthcare provider about all of your medical conditions.

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.

• The most common side effect with Vabysmo was 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.