FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness
– Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME) –
– With as few as two treatments per year, Susvimo may help people with DME maintain their vision –
– Approval marks the second indication for Susvimo in addition to wet, or neovascular age-related macular degeneration (AMD) –
“Susvimo presents a unique, convenient treatment alternative to routine eye injections for people with a potentially blinding diabetic eye condition,” said
“I am excited to offer Susvimo to my patients living with diabetic macular edema who want an option with longer intervals between treatments due to their busy personal and professional lives,” said vitreoretinal surgeon,
The FDA decision was based on positive one-year results from the Phase III Pagoda study, which showed that Susvimo demonstrated sustained vision improvements in people with DME, with safety consistent with the known safety profile for Susvimo. In Pagoda, people with DME who received Susvimo refilled every six months achieved non-inferior improvements in vision compared with those receiving monthly 0.5 mg ranibizumab intravitreal injections (9.6 eye chart letters, similar to gaining two more lines on an eye chart, compared to 9.4 letters, respectively).
Susvimo provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require eye injections as often as once per month. Susvimo was first approved by the FDA for the treatment of wet, or neovascular age-related macular degeneration (AMD) in 2021.
Visit https://www.Susvimo.com for additional information.
About Diabetic Macular Edema (DME)
Affecting approximately 750,000 people in the
About the Pagoda Study
Pagoda (NCT04108156) is a multicenter, randomized, active treatment-controlled, non-inferiority
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
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 Indication
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) and diabetic macular edema (DME) 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 an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab.
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 inflammation in their eye, or have had an allergic reaction to ranibizumab or any of its 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 refill of SUSVIMO.
- If patients are breastfeeding or plan to breastfeed. SUSVIMO is not recommended during breastfeeding. It is not known if SUSVIMO passes into breast milk.
Adverse Reactions
The most common adverse reactions were blood on the white of the eye, redness in the white of the eye, sensitivity to light), and eye pain. 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
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
Outside
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
For additional safety information, please see Lucentis full Prescribing Information, available here: http://www.gene.com/download/pdf/lucentis_prescribing.pdf .
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