New Clinical and Real-World Data for Genentech’s Vabysmo at ASRS Reveal Improved Outcomes for People With Two Leading Causes of Vision Loss

‒ Late-breaking post-hoc data indicate Vabysmo leads to less fibrosis, which may negatively impact vision, than aflibercept in people with diabetic macular edema (DME) –

‒ Real-world data reinforce that first-line Vabysmo use improves outcomes and extends treatment intervals rapidly during the first four months for people with wet age-related macular degeneration (AMD) and DME –

‒ Clinical data reiterate Vabysmo’s positive anatomical outcomes, including reduced blood vessel leakage in the macula and greater and faster retinal fluid control –

‒ Vabysmo is currently approved in over 70 countries to treat wet AMD and DME, with more than one million doses distributed globally –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that data from its ophthalmology portfolio will be highlighted in 25 abstracts at the 2023 American Society of Retina Specialists (ASRS) Annual Meeting, which will be held from July 28 to August 1 in Seattle, WA. The data further advance the depth of clinical and real-world evidence supporting the use of Vabysmo^® (faricimab-svoa), the first and only bispecific antibody for the eye, for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME).

“The clinical and real-world data at ASRS reinforce the improvement in outcomes brought by Vabysmo in two leading causes of vision loss, particularly new analyses suggesting that Vabysmo is associated with less vision-impacting fibrosis than aflibercept,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “By improving disease control while offering a potentially less frequent treatment regimen, Vabysmo may help people spend less time managing their condition.”

Vabysmo is currently approved in over 70 countries to treat wet AMD and DME, with more than one million doses distributed globally. Wet AMD and DME are two leading causes of vision loss, together affecting more than two million people in the United States and 40 million people globally.

The following key data will be presented at ASRS 2023:

Late-breaker: Vabysmo’s effect on epiretinal membrane (ERM) formation in DME compared to aflibercept

Two-year post-hoc data from the YOSEMITE and RHINE Phase III studies will be presented for the first time on ERM formation in DME patients, indicating Vabysmo leads to less retinal fibrosis than aflibercept. ERMs are fibrotic tissues on the surface of the retina, which may negatively impact the anatomy of the eye and compromise vision.

Vabysmo drying and durability data

Data will be presented reiterating positive anatomical outcomes previously seen with Vabysmo treatment, including reduced blood vessel leakage in the macula, and greater and faster retinal fluid control. Blood vessel leakage can cause a build-up of fluid and swelling in the back of the eye, contributing to sight loss.

Data will also further support how increased intervals between doses of Vabysmo to treat wet AMD and DME, compared to aflibercept, do not compromise outcomes.

Vabysmo real-world data

Genentech’s expanding program of real-world studies for Vabysmo includes more than 8,500 participants in almost 30 countries.

• Updates will be presented on real-world data from the FARETINA studies of Vabysmo in wet AMD and DME looking at extended dosing intervals and impact on vision, including Vabysmo’s use as a first-line treatment.
• Preliminary data on early outcomes and treatment patterns in the United Kingdom FARWIDE studies of Vabysmo in wet AMD and DME will be shared for the first time.

In addition, independent investigator studies of Vabysmo are expected to be presented. The TRUCKEE study, which focused on real-world outcomes in people with wet AMD across 14 sites in the United States, is scheduled for presentation on July 31 during the Wet AMD Symposium 3 (1:38 PM to 1:44 PM PDT).

Further information on select Genentech abstracts that will be presented at ASRS 2023 can be found in the table below.

Topic	Abstract Title	Presentation Details
Vabysmo	An Assessment of the Impact of Disease Activity Criteria on Dosing Interval Assignment in Clinical Trial Patients With nAMD	Paper Presentation Session: Wet AMD Symposium 1 July 29, 2023 8:49 AM to 8:53 AM PDT
	Elevatum Study Design and Rationale: A Phase 4 Trial of Faricimab (VABYSMO) in Underrepresented Patients With Diabetic Macular Edema	Paper Presentation Session: Diabetic Retinopathy Symposium 2 July 30, 2023 2:04 PM to 2:07 PM PDT
	Impact of Faricimab vs Aflibercept on Epiretinal Membrane Formation Over 2 Years in Eyes with DME in the YOSEMITE/RHINE Phase 3 Trials	Paper Presentation Session: Late Breaking Abstracts July 30, 2023 3:58 PM to 4:03 PM PDT
	Faricimab Reduces Macular Leakage vs Aflibercept in Patients With DME	Paper Presentation Session: Diabetic Retinopathy Symposium 3 July 31, 2023 10:53 AM to 10:57 AM PDT
	Faricimab Causes Rapid and Sustained Intraocular Suppression of Ang-2 and VEGF-A for Up to 16 Weeks in nAMD and DME	Paper Presentation Session: Diabetic Retinopathy Symposium 3 July 31, 2023 10:57 AM to 11:01 AM PDT
	Time to Retinal Fluid Control With Faricimab vs Aflibercept in Patients With DME in the Phase 3 YOSEMITE/RHINE Trials	Paper Presentation Session: Diabetic Retinopathy Symposium 3 July 31, 2023 11:01 AM to 11:05 AM PDT
	Faricimab Rapidly Improves Fluid Parameters in Patients With nAMD	Paper Presentation Session: Wet AMD Symposium 3 July 31, 2023 1:30 PM to 1:34 PM PDT
	Efficacy, durability, and safety of faricimab in DME: 1-year results from China subpopulation of phase 3 RHINE trial	Virtual Paper on Demand Presentation
Vabysmo Real-World Data	Early Treatment Patterns and Outcomes in Patients with Diabetic Macular Edema Treated with Faricimab: the FARETINA-DME Study	Paper Presentation Session: Diabetic Retinopathy Symposium 3 July 31, 2023 11:05 AM to 11:09 AM PDT
	Early Treatment Patterns and Outcomes in Patients with Neovascular Age-Related Macular Degeneration Initiating Faricimab: the FARETINA-AMD Study	Paper Presentation Session: Wet AMD Symposium 3 July 31, 2023 1:34 PM to 1:38 PM PDT
	Real-world Use of Faricimab to Treat nAMD Patients in the UK	Virtual Paper on Demand Presentation
	Real-world Use of Faricimab to Treat DME Patients in the UK	Poster Presentation
Susvimo	Port Delivery System With Ranibizumab (PDS) for Continuous Treatment in DME and DR: Additional Results From the Phase 3 Pagoda and Pavilion Trials	Paper Presentation Session: Late Breaking Abstracts August 1, 2023 10:53 AM to 10:59 AM PDT
Anti-IL-6 (for Uveitic Macular Edema)	A Novel Intravitreal Anti-IL-6 Monoclonal Antibody for Uveitic Macular Edema (UME): Preliminary Results From the Phase 1 DOVETAIL Study	Paper Presentation Session: Inflammatory & Infectious Diseases Symposium July 29, 2023 4:04 PM to 4:10 PM PDT

About Wet Age-Related Macular Degeneration

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, and 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 Diabetic Macular Edema

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 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, or neovascular, macular degeneration (AMD), and RHONE-X, an extension study of YOSEMITE and RHINE evaluating the long-term safety and tolerability of Vabysmo in diabetic macular edema (DME). In addition, Genentech is investigating the efficacy and safety of Vabysmo in people with macular edema following retinal vein occlusion in two Phase III studies, BALATON and COMINO. Genentech has also initiated several Phase IV studies, including the Elevatum study of Vabysmo in underrepresented patient populations with DME, the SALWEEN study of Vabysmo in a subpopulation of wet AMD highly prevalent in Asia, as well as the VOYAGER study, a global real-world data collection platform. Genentech also supports several other independent studies to further understand retinal conditions with a high unmet need.

About Vabysmo^® (faricimab-svoa)

Vabysmo (faricimab-svoa) is the first bispecific antibody approved for the eye. It targets and inhibits two disease 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) and diabetic macular edema (DME).

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.

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, 7%). 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.

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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