Antibodies play a critical role in the immune system, helping to fight infection and other threats to good health. In recent decades, scientists have begun designing antibody therapies to help thwart certain diseases such as cancer, rheumatoid arthritis, and multiple sclerosis.
The next generation of antibody therapy is the bispecific antibody. These molecules are meant to bind to two different targets, doing a one-to-two punch to combat complex diseases. Now, for the first time, Genentech scientists have successfully applied bispecific antibody technology to the eye, providing a new treatment option for two major types of vision loss.
In early 2022, the US Food and Drug Administration approved VabysmoTM (faricimab-svoa), the first ophthalmic bispecific antibody. This medication treats two main 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. Some require these injections once every month or two.
Fabismo Provides a new approach to treating vision-threatening retinal diseases by targeting and inhibiting two pathological pathways associated with these conditions by neutralizing Angiopoietin-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 blood vessels to leak to form and increase inflammation. Additional research is being conducted to explore the Ang-2 pathway and its role in retinal diseases.
Genentech first began to explore the therapeutic potential of Bispecific antibodies In the early 1990s, motivated by patient needs and driven to push the limits of treatment possibilities.
Together with researchers at the Roche Group, the team worked at the forefront of innovation, relentlessly seeking more precise and personalized treatment options and asking the biggest questions that drove them to create groundbreaking molecular engineering approaches. One of these methods, known as the “knobs in holes” technique, helps to synthesize two different antibody components known as heavy chains in a specific and efficient manner. The technology has become a building block in molecular engineering that has accelerated the research and development of bispecific antibodies. Through these efforts, Genentech has built a portfolio of molecules that provide a combination of precision, stability, and extended targeting ability.
Genentech and Roche scientists have developed bispecific antibody technology with the goal of bringing new hope to patients – underscoring the power of innovation to meet patients’ needs.
US indicators Vabysmo
Vabysmo (faricimab-svoa) is an injectable medication used to treat adults with age-related macular degeneration (AMD) and diabetic macular edema (DME).
Important safety information
Vabysmo is contraindicated in patients who have an infection in or around the eye, have active swelling around the eye that may include pain and redness, or are allergic to Vabysmo or any of the ingredients in Vabysmo.
Warnings and precautions
● Injections such as Vabysmo can cause an eye infection (endophthalmitis) or detachment of the retinal layers (retinal detachment). Patients should seek medical attention if they experience increased eye pain, loss of vision, sensitivity to light, or redness of 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 experienced serious, and sometimes fatal, problems related to blood clots, such as heart attacks or strokes (thromboembolic events). In clinical studies of wet AMD during the first year, 7 out of 664 patients treated with Vabysmo reported such an event. In studies of DME during the first year, 25 out of 1,262 patients treated with Vabysmo reported such an event.
The most common (5%) adverse reaction 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
● Depending on how Vabysmo interacts with your body, there may be a potential risk to the fetus. Patients should use contraception before the first injection, during their treatment with Vabysmo, and for 3 months after the 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 children if they receive Vabysmo.
Patients can 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 important additional safety information in the entire Vabysmo Description information.