Antibodies play a crucial role in the immune system, helping to fight off infections and other threats to good health. In recent decades, scientists have begun to engineer antibody treatments to help thwart specific diseases such as cancer, rheumatoid arthritis and multiple sclerosis.
Genentech
The next generation of antibody treatment is bispecific antibodies. The goal of these molecules is to bind to two different targets, bringing a one-two punch to the fight against complex diseases. And now, for the first time, Genentech scientists have successfully applied bispecific antibody technology to the eye, delivering a new treatment option for two leading forms of vision loss.
In early 2022, the U.S. Food and Drug Administration approved VabysmoTM (faricimab-svoa), the first bispecific antibody for the eye. This medicine treats two leading causes of vision loss, wet age-related macular degeneration (AMD) and diabetic macular edema (DME). While most treatments for wet AMD and DME target a pathway called vascular endothelial growth factor (VEGF), not all patients respond to these treatments. And some require these injections as often as once every month or two.
Vabysmo provides a new approach to treating vision-threatening retinal conditions by targeting and inhibiting two disease pathways linked to these conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. Additional research is being conducted to explore the Ang-2 pathway and its role in retinal disease.
Genentech first began exploring the therapeutic potential for bispecific antibodies in the early 1990s, motivated by patient needs and driven to push the boundaries of treatment possibilities.
Along with researchers across the Roche Group, the team worked at the forefront of innovation, relentlessly pursuing more precise, personalized treatment options and asking the bigger questions that led them to create pioneering molecular engineering methods. One such method, known as the “knobs-into-holes” technology, helps to assemble two different antibody components known as heavy chains in a specific and efficient way. The technology became a building block of molecular engineering that accelerated the investigation and development of bispecific antibodies. And through these efforts, Genentech built a portfolio of molecules that offer a combination of precision, stability and expanded targeting ability.
Genentech and Roche scientists developed bispecific antibody technology with the aim of bringing new hope to patients – further underscoring the power of innovation to meet patient needs.
Vabysmo U.S. Indications
Vabysmo (faricimab-svoa) is a prescription medicine given by injection into the eye, used to treat adults with neovascular (wet) age‑related macular degeneration (AMD) and diabetic macular edema (DME).
Important Safety Information
Contraindications
Vabysmo is contraindicated in patients who have an infection in or around their eye, have active swelling around their eye that may include pain and redness, or are allergic to Vabysmo or any of the ingredients in Vabysmo.
Warnings and Precautions
● Injections like the one for Vabysmo can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment). Patients should seek medical care if they experience 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 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.
Adverse Reactions
The most common adverse reaction (≥5%) reported in patients receiving Vabysmo was blood on the white of the eye (conjunctival hemorrhage, 7%). These are not all the possible side effects of Vabysmo.
Pregnancy, Lactation, Females and Males of Reproductive Potential
● Based on how Vabysmo interacts with your body, there may be a potential risk to an unborn baby. Patients should use birth control before their first injection, during their treatment with Vabysmo, and for 3 months after their last dose of Vabysmo.
● It is not known if Vabysmo passes into breast milk. Patients should talk to their healthcare provider about the best way to feed their baby if they receive Vabysmo.
Patients may report side effects to the FDA at (800) FDA-1088 or
http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835-2555.
Please see additional Important Safety Information in the full Vabysmo Prescribing Information.
M-US-00015858(v1.0)


