– Two-year Phase III data presented at ASRS
2024 show Susvimo’s potential as an alternative to eye injections
to treat diabetic macular edema (DME) and diabetic retinopathy (DR)
–
– Safety data were consistent with the known
safety profile for Susvimo in people with DME and DR –
– Additionally, the FDA has accepted the filing
application for Susvimo in DME and DR based on one-year Pagoda and
Pavilion study data –
– Susvimo is a unique therapeutic approach that
provides continuous delivery of medicine to the eye through a
refillable implant –
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), announced today two-year data from the Phase III Pagoda and
Pavilion studies evaluating Susvimo® (ranibizumab injection) 100
mg/mL for the treatment of diabetic macular edema (DME) and
diabetic retinopathy (DR), respectively, the two leading causes of
vision loss in adults with diabetes. Susvimo is the first and only
refillable eye implant that provides continuous delivery of a
customized formulation of ranibizumab via the Port Delivery
Platform. The results build on the primary one-year analyses of the
Pagoda and Pavilion studies, with Susvimo demonstrating sustained
efficacy over two years and safety consistent with the known safety
profile for Susvimo in people with DME and DR. Detailed results
were presented at the American Society of Retina Specialists (ASRS)
2024 Annual Meeting in Stockholm, Sweden.
Additionally, the U.S. Food and Drug Administration (FDA) has
accepted Genentech’s supplemental Biologics License Application
(sBLA) for Susvimo for the treatment of DME and DR. The filing
acceptance is based on the one-year results from the Phase III
Pagoda and Pavilion studies, which showed that both studies met
their primary endpoint. To date, Susvimo is approved in the U.S.
for the treatment of wet, or neovascular, age-related macular
degeneration (AMD).
“These efficacy and safety results demonstrate that Susvimo can
deliver robust vision outcomes over two years for people with
diabetic eye diseases that can cause vision loss,” said Levi
Garraway, M.D., Ph.D., Genentech’s chief medical officer and head
of Global Product Development. “If approved by the FDA, Susvimo
could bring a new treatment paradigm for diabetic eye diseases. We
hope to bring this option to people with diabetic macular edema and
diabetic retinopathy as soon as possible to help maintain their
vision and potentially their independence.”
One-year primary data supporting U.S. sBLA in DME and
DR
Treatment for DME typically involves regular eye injections
every one to four months. In Pagoda, people with DME who received
Susvimo refilled every six months achieved non-inferior visual
acuity gains compared with those receiving monthly 0.5 mg
ranibizumab intravitreal injections. Approximately 95% of patients
treated with Susvimo did not need additional treatment with
supplemental injections during the primary analyses study period
(64 weeks). In Pavilion, people with DR who received Susvimo
refilled every nine months achieved superior improvements on the
Diabetic Retinopathy Severity Scale (DRSS) compared with
participants under monthly clinical observation. No individuals
treated with Susvimo needed additional treatment with supplemental
injections during the primary analyses study period (52 weeks),
compared to 60% in the control arm.
Two-year Pagoda and Pavilion results presented at
ASRS
In Pagoda, people with DME receiving Susvimo refilled every six
months through approximately two years (112 weeks) continued to
maintain improvements in vision gains seen at one year (9.8 eye
chart letters). A gain of 9.8 eye chart letters is similar to
gaining two more lines on an eye chart. Approximately 95% of
individuals did not need additional treatment with supplemental
injections. Anatomically, Susvimo showed sustained improvements in
central subfield thickness (CST) through week 112. Reduction in
CST, a measure of retinal drying, is an indicator of swelling from
fluid in the back of the eye caused by unstable, leaky blood
vessels. The safety data were consistent with the known safety
profile for Susvimo in people with DME, with no new safety signals
observed. In people treated with Susvimo, no cases of
endophthalmitis were reported up to one year and the rate of
endophthalmitis through week 112 was 0.7%, compared to 0.8% in the
control arm. Refills of Susvimo were resumed in affected
participants after successful resolution of endophthalmitis.
In Pavilion, people with DR receiving Susvimo refilled every
nine months through approximately two years (100 weeks) maintained
DRSS improvements seen at one year. Specifically, at week 100, 80%
of Susvimo participants achieved a two-step or greater improvement
on the DRSS from pre-implant baseline, and participants who
received Susvimo from week 64 either maintained or improved their
DRSS score from pre-implant baseline. A two-step or greater
improvement in the DRSS is a clinically relevant measure of the
decrease in risk for developing vision-threatening complications
secondary to diabetes. Approximately 98% of participants treated
with Susvimo did not need additional treatment with supplemental
injections. The safety data were consistent with the known safety
profile for Susvimo in people with DR, with no new safety signals
observed. In people treated with Susvimo, no cases of
endophthalmitis were reported up to one year and the rate of
endophthalmitis through week 100 was 0.8%. One participant with DR
developed endophthalmitis and continued receiving treatment with
Susvimo refills after successful resolution.
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 https://www.Susvimo.com for additional information.
About Diabetic Macular Edema (DME)
Affecting approximately 750,000 people in the U.S., 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 Diabetic Retinopathy (DR)
Diabetic retinopathy (DR) affects approximately 7.7 million
Americans and 93 million people globally, accounting for almost 5%
of all cases of blindness. DR can lead to the development of DME,
which is a leading cause of vision loss, affecting around 21
million adults worldwide. The longer a person has diabetes,
especially if it is poorly controlled, the higher the risk of
developing diabetic retinopathy and vision loss. Diabetic
retinopathy occurs when blood vessels in the retina become damaged.
This can cause vision loss or distortion when the abnormal vessels
leak blood or fluid into the eye.
About the Pagoda Study
Pagoda (NCT04108156) is a multicenter, randomized, active
treatment-controlled, non-inferiority U.S.-based Phase III study
evaluating the efficacy, safety and pharmacokinetics of Susvimo®
(ranibizumab injection) 100 mg/mL refilled every six months
compared with monthly ranibizumab 0.5 mg intravitreal injections,
in 634 people with diabetic macular edema. Participants were
randomized 3:2 to receive either Susvimo refilled every six months
or continued monthly intravitreal ranibizumab injections. In the
Susvimo arm, participants received four loading doses of
intravitreal ranibizumab before Susvimo implantation at week 16.
The primary endpoint of the study is a change in best-corrected
visual acuity score (the best distance vision a person can achieve
– including with correction such as glasses – when reading letters
on an eye chart) from baseline at the average of week 60 and week
64. Following primary analysis, participants who were initially
randomized to intravitreal injections received Susvimo, with
refills every 24 weeks.
About the Pavilion Study
Pavilion (NCT04503551) is a multicenter, randomized, U.S.-based
Phase III study evaluating the efficacy, safety and
pharmacokinetics of Susvimo® (ranibizumab injection) 100 mg/mL
refilled every nine months compared with people under monthly
clinical observation, in 174 people with diabetic retinopathy
without center-involved diabetic macular edema. Participants were
randomized 5:3 to receive either Susvimo with refills every nine
months or monthly clinical observation, respectively. In the
Susvimo arm, participants received two loading doses of
intravitreal ranibizumab, before Susvimo implantation at week 4.
The primary endpoint was the proportion of participants with at
least a two-step improvement from baseline on the Early Treatment
Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale at
week 52. Following the primary analysis, participants initially in
the clinical observation arm received two ranibizumab loading doses
before Susvimo implantation at week 64.
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
http://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 https://www.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
http://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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