Genentech to Reintroduce Susvimo for People With Wet Age-related Macular Degeneration (AMD)

– 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.

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