– More than 90% of patients had absence of DME
after four years in a pre-specified exploratory endpoint –
– People treated with Vabysmo sustained vision
gains and anatomical improvements, with almost 80% receiving
treatment at intervals of three or four months, in an exploratory
analysis –
– The study met all primary endpoints showing
safety data were consistent with Vabysmo's known safety profile
–
– This is the largest long-term extension
dataset in DME to-date, demonstrating consistent positive results
in a highly prevalent eye condition –
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY) announced today new, four-year data from the RHONE-X
extension study. The study met all primary endpoints, showing that
Vabysmo® (faricimab-svoa) was well tolerated in people with
diabetic macular edema (DME) who received treatment for up to four
years. Exploratory results from the long-term study showed that
Vabysmo continued to preserve vision, dry retinal fluid that can
impair sight and allow extended time between treatments in people
with DME. These data were presented in a late-breaking oral
presentation at the American Society of Retina Specialists (ASRS)
2024 Annual Meeting in Stockholm, Sweden.
“These four-year data build on our pivotal studies and reinforce
Vabysmo’s potential to become standard of care treatment for
diabetic macular edema (DME), which affects 29 million people
worldwide,” said Levi Garraway, M.D., Ph.D., Genentech’s chief
medical officer and head of Global Product Development. “We are
especially pleased to see that 9 out of 10 patients showed no sign
of DME after four years of treatment with Vabysmo, which is an
incredible long-term outcome for people living with this
condition.”
The RHONE-X study is the largest long-term extension dataset in
DME, a leading cause of vision loss in people with diabetes.
“I have been using Vabysmo as a first-line treatment for all the
approved indications, including diabetic macular edema, and the
positive long-term safety and efficacy results from the RHONE-X
study are consistent with my clinical experience for over two
years,” said study investigator Arshad M. Khanani, M.D., director
of clinical research at Sierra Eye Associates and clinical
professor at the University of Nevada, Reno, who presented the data
at ASRS.
During RHONE-X, all participants were treated with Vabysmo on a
personalized treat-and-extend regimen, where the time between
Vabysmo treatments could be increased based on retinal fluid levels
and visual acuity. Results of the exploratory analysis showed that
at the end of four years nearly 80% of participants treated with
Vabysmo had extended their treatment intervals to every three or
four months. Additionally, people treated with Vabysmo maintained
the vision improvements and sustained the drying of retinal fluid
they achieved during the initial Phase III studies (YOSEMITE and
RHINE). In a pre-specified exploratory endpoint, more than 90% of
people treated with Vabysmo achieved absence of DME, defined as
central subfield thickness (CST) less than 325 microns. CST is a
measure of swelling from fluid in the back of the eye caused by
unstable, leaky blood vessels; reducing CST indicates retinal
drying.
To date, Vabysmo is approved in nearly 100 countries for DME and
wet, or neovascular, age-related macular degeneration (AMD). It is
also approved in several countries, including the United States
(U.S.) and Japan, for the treatment of macular edema following
retinal vein occlusion. More than four million doses of Vabysmo
have been distributed worldwide 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 https://www.Vabysmo.com for additional information.
About RHONE-X
RHONE-X is a multicenter two-year extension study designed to
evaluate the long-term safety and tolerability of Vabysmo®
(faricimab-svoa) in 1,474 patients with diabetic macular edema who
completed one of the two Phase III studies, YOSEMITE (NCT03622580)
or RHINE (NCT03622593). Patients in YOSEMITE and RHINE were treated
with either Vabysmo or 2 mg aflibercept. Patients in RHONE-X were
all treated with Vabysmo according to a personalized treatment
interval.
The primary objectives were to evaluate the long-term safety and
tolerability of Vabysmo, including ocular adverse events (AEs),
non-ocular AEs and presence of anti-drug antibodies. The study also
had an exploratory objective to assess the long-term efficacy of
Vabysmo.
About Diabetic Macular Edema
Affecting approximately 750,000 people in the United States,
diabetic macular edema (DME) is a vision-threatening retinal
condition associated with blindness and decreased quality of life
when left untreated. DME occurs when damaged blood vessels in the
retina leak into and cause swelling in the macula – the central
area of the retina responsible for the sharp vision needed for
reading and driving. The number of people with DME is expected to
grow as the prevalence of diabetes increases.
About the Vabysmo® (faricimab-svoa) Clinical Development
Program
Genentech has a robust Phase III clinical development program
for Vabysmo. The program includes AVONELLE-X, an extension study of
TENAYA and LUCERNE, evaluating the long-term safety and
tolerability of Vabysmo in wet age-related macular degeneration
(AMD). Genentech has also initiated several Phase IV studies,
including the ELEVATUM study of Vabysmo in underrepresented patient
populations with DME and the SALWEEN study of Vabysmo in a
subpopulation of wet AMD highly prevalent in Asia. Genentech has
also initiated the VOYAGER study, a global real-world data
collection platform, and supports several other independent studies
to further understand retinal conditions with a high unmet
need.
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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