– Vabysmo PFS is the first and only syringe
prefilled with an FDA-approved bispecific antibody to treat retinal
conditions that can cause blindness –
– Designed to simplify administration, Vabysmo
PFS provides retina specialists a ready-to-use option –
– Vabysmo PFS will be available for people
living with wet AMD, DME and RVO –
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY) announced today the U.S. Food and Drug Administration (FDA)
has approved the Vabysmo® (faricimab-svoa) 6.0 mg single-dose
prefilled syringe (PFS) for use in the treatment of wet, or
neovascular, age-related macular degeneration (AMD), diabetic
macular edema (DME) and macular edema following retinal vein
occlusion (RVO). Together, these three conditions affect close to
three million people in the U.S. The Vabysmo PFS will become
available to U.S. retina specialists and their patients in the
coming months.
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The Vabysmo prefilled syringe, developed
by Genentech, was approved by the FDA in July 2024. (Photo:
Business Wire)
“We are pleased that the U.S. FDA has approved the Vabysmo PFS
for people living with wet AMD, DME and RVO, which are some of the
leading causes of vision loss,” said Levi Garraway, M.D., Ph.D.,
Genentech’s chief medical officer and head of Global Product
Development. “While many retina specialists are already using
Vabysmo as a first-line treatment, this new offering should make it
even simpler to administer, thereby enhancing the treatment
experience for both physicians and patients.”
Vabysmo PFS delivers the same medicine as the currently
available Vabysmo vials in an alternative, ready-to-use format.
Vabysmo will continue to be available in a 6.0 mg vial.
Vabysmo is the first and only bispecific antibody approved for
the eye and has demonstrated rapid and robust vision improvements
and retinal drying in wet AMD, DME and RVO. Retinal drying is an
important clinical measure, as swelling from excess fluid in the
back of the eye is associated with distorted and blurred
vision.
To date, Vabysmo is approved in more than 95 countries for wet
AMD and DME, and in several countries, including the U.S. and
Japan, for RVO. Review by other health authorities across the globe
is ongoing. More than four million doses of Vabysmo have been
distributed globally since its initial U.S. approval in 2022.
Genentech is committed to helping people access the medicines
they are prescribed and offers comprehensive services for people
prescribed Vabysmo to help minimize barriers to access and
reimbursement. Patients can call 833-EYE-GENE for more information.
For people who qualify, Genentech offers patient assistance
programs through Genentech Access Solutions. More information is
also available at (866) 4ACCESS/(866) 422-2377 or
http://www.Genentech-Access.com.
Visit Vabysmo.com for additional information.
About Vabysmo® (faricimab-svoa)
Vabysmo is the first bispecific antibody approved for the eye.
It targets and inhibits two signaling pathways linked to a number
of vision-threatening retinal conditions by neutralizing
angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A
(VEGF-A). While research is underway to better understand the role
of the Ang-2 pathway in retinal disease, 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. By blocking pathways involving Ang-2 and
VEGF-A, Vabysmo is designed to stabilize blood vessels.
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), diabetic macular edema
(DME) and macular edema following retinal vein occlusion (RVO).
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 from baseline to
week 100, 64 out of 1,262 patients treated with Vabysmo reported
such an event. In clinical studies for RVO during 6 months, 7 out
of 641 patients treated with Vabysmo reported such an event.
- 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.
Adverse Reactions
The most common adverse reactions (≥5%) reported in patients
receiving Vabysmo were cataract (15%) and blood on the white of the
eye (conjunctival hemorrhage, 8%). 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 or visit
https://www.Vabysmo.com.
About Genentech in Ophthalmology
Genentech is researching and developing new treatments for
people living with a range of eye diseases that cause significant
visual impairment and blindness, including wet age-related macular
degeneration (AMD), diabetic macular edema (DME), diabetic
retinopathy (DR), geographic atrophy (GA) and other retinal
diseases, including rare and inherited conditions.
About Genentech
Founded more than 40 years ago, Genentech is a leading
biotechnology company that discovers, develops, manufactures and
commercializes medicines to treat patients with serious and
life-threatening medical conditions. The company, a member of the
Roche Group, has headquarters in South San Francisco, California.
For additional information about the company, please visit
http://www.gene.com.
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