– The FDA has approved updates to Susvimo,
which will be available to U.S. retina specialists and patients
with wet AMD in the coming weeks –
– Susvimo offers the first alternative to
regular eye injections that are standard of care for wet AMD, which
impacts 1.5 million people in the U.S. and 20 million people
worldwide and can cause blindness if left untreated –
– By continuously delivering medicine to the
eye through a refillable implant, Susvimo is the first and only
approved wet AMD treatment shown to maintain vision with two
refills a year –
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), announced today the reintroduction of Susvimo® (ranibizumab
injection) 100 mg/mL for intravitreal use via ocular implant for
the treatment of people in the United States (U.S.) with wet, or
neovascular, age-related macular degeneration (AMD), following the
end of a voluntary recall. The U.S. Food and Drug Administration
(FDA) has approved a post-approval supplement to the Biologics
License Application for Susvimo, reflecting component-level updates
made to the ocular implant and refill needle. Genentech will work
to make Susvimo available in the U.S. to retina specialists and
their patients with wet AMD in the coming weeks.
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Susvimo, developed by Genentech, a member
of the Roche Group, is a refillable eye implant that continuously
delivers a customized formulation of ranibizumab over time. (Photo:
Business Wire)
“We are pleased to reintroduce Susvimo, a unique therapeutic
approach shown to provide an effective alternative to regular eye
injections by preserving vision with two refills per year in Phase
III study patients with wet AMD,” said Levi Garraway, M.D., Ph.D.,
Genentech’s chief medical officer and head of Global Product
Development. “Susvimo’s return to the retina community reflects our
unwavering commitment to provide innovative retinal treatments, and
lays the groundwork for future advancements.”
Susvimo provides continuous delivery of a customized formulation
of ranibizumab via the Port Delivery Platform, while other
currently approved treatments may require multiple eye injections
per year.
The Susvimo implant is surgically inserted into the eye during a
one-time, outpatient procedure and is refilled once every six
months using a specifically designed needle, which introduces a
customized formulation of ranibizumab directly into the device.
Susvimo was approved by the FDA in 2021. The following year,
Genentech voluntarily recalled the ocular implant, insertion tool
and initial fill kit in the U.S. following test results that showed
some implants did not perform to Genentech’s standards. Genentech
has since updated the Susvimo implant and refill needle, and
testing confirmed that they now meet these performance standards.
Manufacturing process improvements were also implemented.
Genentech is committed to helping people access the medicines
they are prescribed and offers comprehensive services for people
prescribed Susvimo 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 Susvimo.com for additional information.
About Wet Age-Related Macular Degeneration (AMD)
Age-related macular degeneration (AMD) is a condition that
affects the macula, the part of the eye that provides sharp,
central vision needed for activities like reading. It is a leading
cause of blindness for people aged 60 and over in the U.S. Wet, or
neovascular, AMD is an advanced form of the disease that can cause
rapid and severe vision loss. Approximately 20 million people in
the U.S. have some form of AMD, and of those, about 1.5 million
have late-stage AMD, which includes wet AMD.
Wet AMD is caused by growth of abnormal blood vessels, also
referred to as choroidal neovascularization (CNV), into the macula.
These vessels leak fluid and blood and cause scar tissue that
destroys the central retina. This process results in a
deterioration of sight over a period of months to years.
About Susvimo® (ranibizumab injection) 100 mg/mL for
intravitreal use via ocular implant
Susvimo® (ranibizumab injection) 100 mg/mL for intravitreal use
via ocular implant is a refillable implant surgically inserted into
the eye during a one-time, outpatient procedure. Susvimo
continuously delivers a customized formulation of ranibizumab over
time. Susvimo is indicated for intravitreal use via the Susvimo eye
implant only. Ranibizumab is a vascular endothelial growth factor
(VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein
that has been shown to play a critical role in the formation of new
blood vessels and the leakiness of the vessels. Susvimo was
previously called the Port Delivery System with ranibizumab in the
U.S.
The customized formulation of ranibizumab delivered by Susvimo
is different from the ranibizumab intravitreal injection, a
medicine marketed as Lucentis® (ranibizumab injection), which is
approved to treat wet, or neovascular, age-related macular
degeneration (AMD) and other retinal diseases. Lucentis was first
approved for wet AMD by the FDA in 2006.
Susvimo U.S. Indications
Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use
via ocular implant is indicated for the treatment of patients with
neovascular (wet) age-related macular degeneration (AMD) who have
previously responded to at least two intravitreal injections of a
vascular endothelial growth factor inhibitor medication.
Susvimo Important Safety Information
WARNING: ENDOPHTHALMITIS
The Susvimo implant has been associated with a 3-fold higher
rate of endophthalmitis than monthly intravitreal injections of
ranibizumab. In clinical trials, 2.0% of patients receiving an
implant experienced at least 1 episode of endophthalmitis.
Warnings and Precautions:
The Susvimo implant and the procedures associated with
inserting, filling, refilling, and (if medically necessary)
removing the implant can cause other serious side effects,
including:
- An eye infection (endophthalmitis). Endophthalmitis is
an infection of the eyeball that can cause permanent damage to your
eye, including blindness. Endophthalmitis requires urgent
(same-day) medical or surgical treatment.
- A missing layer on top of the white part of the eye
(conjunctival erosion). Conjunctival erosion is an area that
becomes missing (defect) in the layer (conjunctiva) that covers the
white part of the eye, which may result in exposure of the implant.
Conjunctival erosion may require surgical treatment.
- An opening of the layer that covers the white part of the
eye (conjunctival retraction). Conjunctival retraction is an
opening or gaping in the layer (conjunctiva) that covers the white
part of the eye, which may cause the implant to be exposed.
Conjunctival retraction may require surgical treatment.
- Tear and separation of layers of the retina (rhegmatogenous
retinal detachment). Rhegmatogenous retinal detachment is a
tear and separation of one of the layers of the retina in the back
of the eye that senses light. Rhegmatogenous retinal detachment
requires surgical treatment.
- Implant movement (implant dislocation): This movement
may require surgical treatment to correct.
- Implant damage: Damage to the implant that prevents
continued treatment (refills) with Susvimo. If the implant is not
able to be properly refilled, a patient’s wet AMD may be
inadequately treated and a physician may remove the implant and/or
change the treatment.
- Bleeding (vitreous hemorrhage): Vitreous hemorrhage is
bleeding within the gel-like substance (vitreous) inside of your
eye. This may require an additional eye surgery.
- Bump on top of the white layer of the eye (conjunctival
bleb): Conjunctival bleb is a small bulge in the layer
(conjunctiva) that covers the white part of the eye where the
implant is inserted. This may be due to leakage of fluid from the
inside of the eye. This may require medical or surgical
treatment.
- Temporary decrease in vision after the Susvimo
procedure.
Who should not receive Susvimo?
- Patients who have an infection in or around their eye, have
active swelling around your eye that may include pain and redness,
or have had an allergic reaction to ranibizumab or any of the
ingredients in Susvimo in the past.
Information for patients who are of childbearing
potential
- If patients are pregnant, think that they might be pregnant, or
plan to become pregnant: It is not known if Susvimo will harm an
unborn baby. Patients should use birth control (contraception)
during treatment with Susvimo and for 12 months after the last dose
of Susvimo.
Adverse Reactions
The most common adverse reactions were blood on the white of the
eye (72%), redness in the white of the eye (26%), sensitivity to
light (23%), and eye pain (10%). These are not all the possible
side effects of Susvimo.
You may report side effects to the FDA at (800) FDA-1088 or
www.fda.gov/medwatch. You may also report side effects to Genentech
at (888) 835-2555.
Please see additional Important Safety Information in the full
Susvimo Prescribing Information, including BOXED WARNING or
visit Susvimo.com.
About Lucentis® (ranibizumab injection)
Lucentis is a vascular endothelial growth factor (VEGF)
inhibitor designed to bind to and inhibit VEGF-A, a protein that is
believed to play a critical role in the formation of new blood
vessels (angiogenesis) and the hyperpermeability (leakiness) of the
vessels.
Lucentis is FDA-approved for the treatment of patients with wet
age-related macular degeneration (AMD), macular edema following
retinal vein occlusion (RVO), diabetic macular edema (DME),
diabetic retinopathy (DR) and myopic choroidal neovascularization
(mCNV).
Lucentis was developed by Genentech, a member of the Roche
Group. The company retains commercial rights in the United States
and Novartis has exclusive commercial rights for the rest of the
world.
Outside the United States, Lucentis is approved in more than 120
countries to treat adult patients with wet AMD, and for the
treatment of visual impairment due to DME, due to macular edema
secondary to both branch retinal vein occlusion (BRVO) and central
retinal vein occlusion (CRVO), and due to choroidal
neovascularization (CNV).
Lucentis Important Safety Information
Lucentis is contraindicated in patients with ocular or
periocular infections or known hypersensitivity to ranibizumab or
any of the excipients in Lucentis. Hypersensitivity reactions may
manifest as severe intraocular inflammation.
Intravitreal injections, including those with Lucentis, have
been associated with endophthalmitis, retinal detachment, and
iatrogenic traumatic cataract.
Increases in intraocular pressure have been noted both
pre-injection and post-injection with Lucentis.
Although there was a low rate of arterial thromboembolic events
(ATEs) observed in the Lucentis clinical trials, there is a
potential risk of ATEs following intravitreal use of VEGF
inhibitors. ATEs are defined as nonfatal stroke, nonfatal
myocardial infarction, or vascular death (including deaths of
unknown cause).
Fatal events occurred more frequently in patients with DME and
DR at baseline treated monthly with Lucentis compared with control.
Although the rate of fatal events was low and included causes of
death typical of patients with advanced diabetic complications, a
potential relationship between these events and intravitreal use of
VEGF inhibitors cannot be excluded.
Retinal vasculitis and/or retinal vascular occlusion have been
reported. Patients should be instructed to report any change in
vision without delay.
In the Lucentis Phase III clinical trials, the most common
ocular side effects included conjunctival hemorrhage, eye pain,
vitreous floaters, and increased intraocular pressure. The most
common non-ocular side effects included nasopharyngitis, anemia,
nausea, and cough.
You may report side effects to the FDA at (800) FDA-1088 or
www.fda.gov/medwatch. You may also report side effects to Genentech
at (888) 835-2555.
For additional safety information, please see Lucentis full
Prescribing Information, available here:
http://www.gene.com/download/pdf/lucentis_prescribing.pdf.
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.
All trademarks used or mentioned in this release are protected
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