New Long-Term Data for Genentech’s Vabysmo Show Sustained Retinal Drying and Vision Improvements in Retinal Vein Occlusion (RVO)

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new 72-week data from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo^® (faricimab-svoa) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO). Whereas available RVO treatments are typically given every one to two months, the data showed nearly 60% of people receiving Vabysmo in BALATON and up to 48% of people in COMINO were able to extend their treatment intervals to three or four months apart. In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year. Retinal drying is an important clinical measure as swelling from excess fluid in the back of the eye has been associated with distorted and blurred vision. In both studies, Vabysmo was well tolerated and the safety profile was consistent with previous studies.

“This is the first time that vision and anatomical improvements have been maintained for more than a year in global Phase III studies for both branch and central retinal vein occlusion,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “These long-term results build on the strong clinical and real-world data reinforcing Vabysmo as an effective treatment option for people affected by retinal conditions that can cause vision loss.”

Results will be presented virtually on Feb. 3 at Angiogenesis, Exudation, and Degeneration 2024, organized by Bascom Palmer Eye Institute in Florida.

“The sustained vision improvements and retinal drying seen up to 72 weeks reaffirm Vabysmo as an effective treatment for retinal vein occlusion,” said Ramin Tadayoni, M.D., Ph.D., head of ophthalmology at Université Paris Cité in Paris and president of EURETINA, who is presenting the data at Angiogenesis. “More treatment options are needed to better serve people living with this condition, and these data show Vabysmo can potentially improve outcomes while reducing the number of clinic visits needed.”

Both studies evaluated the average change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline. The studies also tracked the amount of swelling in the back of the eye due to retinal fluid, as measured by central subfield thickness (CST). Reductions in CST indicate improvement. Overall, results showed the vision improvements and reductions in retinal fluid achieved in the first 24 weeks of the studies were maintained up to 72 weeks.

Results for BRVO (BALATON):

• Vision gains: At 72 weeks, people receiving Vabysmo as a first-line treatment gained 18.1 letters on the eye chart, while people switched from aflibercept to Vabysmo gained 18.8 letters. During the first 24 weeks, vision gains were +16.8 eye chart letters in people receiving Vabysmo and +17.5 letters in people receiving aflibercept.
• Retinal drying: At 72 weeks, people receiving Vabysmo as a first-line treatment saw a 310.9 µm reduction in retinal swelling, as measured by CST, while those switched from aflibercept to Vabysmo saw a reduction in CST of 307 µm. During the first 24 weeks of the study, CST reductions were 314.5 µm in people receiving Vabysmo and 307.6 µm in people receiving aflibercept.

Results for CRVO (COMINO):

• Vision gains: People receiving Vabysmo as a first-line treatment gained 16.9 eye chart letters at 72 weeks, while people switched from aflibercept to Vabysmo gained 17.1 eye chart letters. During the first 24 weeks of the study, vision gains were +16.9 eye chart letters in people receiving Vabysmo and +17.3 letters in people receiving aflibercept.
• Retinal drying: People receiving Vabysmo as a first-line treatment saw a 465.9 µm reduction in retinal swelling, as measured by CST, while those switched from aflibercept to Vabysmo saw a reduction in CST of 460.6 µm at 72 weeks. During the first 24 weeks of the study, reductions in CST were 462.3 µm in people receiving Vabysmo and 447.8 µm in people receiving aflibercept.

Vabysmo is the first and only 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.

To date, Vabysmo is approved in more than 90 countries around the world for people living with wet age-related macular degeneration and diabetic macular edema, with more than 2.5 million doses distributed globally.

In October 2023, the U.S. Food and Drug Administration approved Vabysmo for the treatment of macular edema following RVO.

About the BALATON and COMINO Studies

BALATON (NCT04740905) and COMINO (NCT04740931) are two randomized, multicenter, double-masked, global Phase III studies evaluating the efficacy and safety of Vabysmo^® (faricimab-svoa) compared to aflibercept. For the first 20 weeks, patients were randomized 1:1 to receive monthly injections for six months of either Vabysmo (6.0 mg) or aflibercept (2.0 mg). From weeks 24 to 72, all patients received Vabysmo (6.0 mg) up to every four months, using a treat-and-extend dosing regimen.

The BALATON study was conducted in 553 people with branch retinal vein occlusion. The COMINO study was conducted in 729 people with central retinal or hemiretinal vein occlusion. The primary endpoint of each study was the change in best-corrected visual acuity from baseline at 24 weeks. Secondary endpoints (weeks 0-24) included change in central subfield thickness and drying of retinal fluid, from baseline over time up to week 24. Secondary endpoints (weeks 24-72) assessed change in BCVA from baseline, change in CST from baseline and the proportion of individuals on treat-and-extend intervals.

About Retinal Vein Occlusion (RVO)

RVO is the second most common cause of vision loss due to retinal vascular conditions. It affects more than 1 million people in the U.S., mainly those aged 60 or older, and can lead to severe and sudden vision loss. The level of angiopoietin-2 (Ang-2) is elevated in RVO and it is thought that increased Ang-2 expression drives disease progression. RVO typically results in sudden, painless vision loss in the affected eye because the vein blockage restricts normal blood flow in the affected retina, resulting in ischemia, bleeding, fluid leakage and retinal swelling called macular edema. Currently, macular edema due to RVO is typically treated with repeated intravitreal injections of anti-vascular endothelial growth factor therapies. There are two main types of RVO: branch retinal vein occlusion, which affects an estimated 887,000 people in the U.S. and occurs when one of the four smaller branches of the main central retinal vein becomes blocked; and central retinal vein occlusion, which is less common, affecting an estimated 265,000 people in the U.S., and occurs when the eye’s central retinal vein becomes blocked.

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, age-related 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). 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 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). 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), 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.

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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