• New real-world results for Vabysmo in wet AMD, DME and RVO reinforce robust effectiveness and durability across previously untreated and treated eyes, with no new safety signals
• Advanced AI-enabled analysis of imaging confirms rapid and meaningful anatomical drying supporting Vabysmo as a standard-of-care therapy in routine clinical care
• With more than 5,000 patients enrolled, VOYAGER is the largest, prospective, non-interventional real-world dataset evaluating Vabysmo across diverse clinical practice settings worldwide

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today new data from the VOYAGER study evaluating the effectiveness, durability and safety of Vabysmo^® (faricimab-svoa) in wet age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Across all study cohorts, results confirm the real-world effectiveness of Vabysmo in line with Phase III trial results, with vision gains and robust anatomical improvements in untreated eyes and stable or improved vision with improved anatomical outcomes in previously treated eyes.

In the wet AMD and DME cohorts of the study, vision and central subfield thickness (CST) improved in previously untreated eyes, while vision remained stable and CST improved in previously treated eyes, after 12 months of Vabysmo treatment. In RVO, both subtypes of the disease showed improvements in efficacy in people treated with Vabysmo. In the central/hemi-RVO cohort, vision and CST improved in both previously untreated and treated eyes after six months of Vabysmo therapy. In the branch RVO cohort, vision and CST improved in previously untreated eyes, while vision remained stable and CST improved in previously treated eyes, after six months of Vabysmo treatment. The data are being presented at the EURETINA 2026 Annual Meeting in Vienna, Austria.

“These real-world results underscore how the efficacy and safety observed in our pivotal Vabysmo studies translate directly into routine clinical practice globally,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “The sustained visual improvements and meaningful anatomical drying seen in the VOYAGER study reinforce the role of Vabysmo in helping to address important unmet needs for patients with retinal conditions.”

“In daily clinical practice, we manage diverse patient populations with complex treatment histories who don’t always mirror the strict entry criteria of controlled Phase III trials,” said Professor Robyn Guymer, Chair of the VOYAGER Steering Committee and Deputy Director of the Centre for Eye Research Australia. “The latest VOYAGER data give physicians from across the world the confidence that Vabysmo delivers sustained visual gains, meaningful anatomical drying, and an established safety profile in everyday practice – whether a patient is starting treatment for the first time or transitioning from another therapy.”

The new VOYAGER real-world data in wet AMD, DME and RVO are consistent with previous Phase III study results and demonstrate the effectiveness, durability and safety of Vabysmo across diverse global practices. Across all cohorts of the study, the presence of subretinal fluid (SRF) or intraretinal fluid (IRF) was consistently reduced in previously untreated and treated eyes. In the wet AMD and DME groups, fewer Vabysmo injections were received during months 7-12 compared with months 1-6, suggesting extension of treatment intervals.

In VOYAGER, the Vabysmo safety profile was generally consistent with that established in the Phase III studies in wet AMD, DME and RVO.

About VOYAGER

VOYAGER is the largest global, prospective, non-interventional real-world study of Vabysmo (faricimab-svoa). It captures real-world data from 28 countries/regions across six continents representing more than 5,000 patients treated for wet age-related macular degeneration (AMD), diabetic macular edema (DME) or retinal vein occlusion (RVO). The study leverages state-of-the-art AI and deep learning algorithms to evaluate SD-OCT images captured during routine clinical practice.

About Vabysmo^® (faricimab-svoa)

Vabysmo is the first bispecific antibody approved for the eye. It targets and inhibits two signaling pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilizing blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels. Vabysmo is approved in more than 100 countries around the world, including the United States (U.S.), Japan, the United Kingdom and the European Union (E.U.) for people with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in more than 60 countries, including the U.S., E.U. and Japan, for people with macular edema following retinal vein occlusion (RVO). Review by other health authorities is ongoing.

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), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).

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. In clinical studies for RVO during 6 months, 7 out of 641 patients treated with Vabysmo reported such an event.
• Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of Vabysmo. Healthcare providers should discontinue treatment with Vabysmo in patients who develop these events. Patients should be instructed to report any change in vision without delay.

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, 8%). 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, including rare and inherited conditions.

About Genentech

Founded 50 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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