‒ In the TENAYA and LUCERNE studies, more than 60% of Vabysmo patients could be treated every four months at two years. This represents an increase from 45% at year one –

‒ Patients treated with Vabysmo received a median number of 10 injections over the two years versus 15 injections for those treated with aflibercept, potentially decreasing the number of injections –

‒ No new safety signals were identified, and Vabysmo continued to be well tolerated, with a favorable benefit-risk profile –

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new two-year data from the TENAYA and LUCERNE studies that reinforce the long-term efficacy, safety and durability of Vabysmo^® (faricimab-svoa) in wet, or neovascular, age-related macular degeneration (AMD), a leading cause of vision loss. Wet AMD affects nearly 1.1 million people in the U.S. and can require treatment with eye injections every one to two months. The two-year data were presented at the 2022 American Society of Retina Specialists Annual Scientific Meeting on July 14.

“These longer-term results reinforce confidence in Vabysmo and support its continued use in people with wet AMD,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “With the potential to require fewer injections over time, Vabysmo continues to represent an important step forward for people with vision-threatening retinal conditions, and these data exemplify our commitment to redefining standards of care and reducing treatment burden.”

In the TENAYA and LUCERNE studies, at two years:

• More than 60% of people receiving Vabysmo could be treated every four months – an increase of over 15 percentage points since the primary analysis at one year – while achieving comparable vision gains versus aflibercept given every two months.
• Nearly 80% of people receiving Vabysmo could be treated every three months or longer.
• Patients treated with Vabysmo received a median number of 10 injections over the two years versus 15 injections for those patients treated with aflibercept, potentially decreasing the number of injections.
• Comparable reductions in central subfield thickness (CST) were observed with Vabysmo given at intervals of up to four months versus aflibercept given every two months.
• No new safety signals were identified, and Vabysmo continued to be well tolerated, with a favorable benefit-risk profile.

The primary analyses at one year formed the basis of the recent wet AMD approvals in the U.S., Japan, the U.K. and several other countries around the world. Vabysmo is also approved in these countries for diabetic macular edema (DME). Vabysmo is currently under review by the European Medicines Agency for these conditions, and submissions to other regulatory authorities around the world are ongoing.

Vabysmo is the first bispecific antibody for the eye and the only injectable eye medicine approved by the U.S. Food and Drug Administration (FDA) with the option for treatments from one to four months apart in the first year following four initial monthly loading doses, based on evaluation of the patient’s anatomy and vision outcomes. Vabysmo is designed to block 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.

Detailed Two-Year Results

In the TENAYA and LUCERNE studies, wet AMD patients received Vabysmo given at intervals of two, three or four months or aflibercept given every two months. In the second year, the dosing schedule for Vabysmo patients could be adjusted based on their response to treatment.

At two years, vision improvements were comparable across both treatment arms. In TENAYA, the average vision gains from baseline at two years were +3.7 eye chart letters in the Vabysmo arm and +3.3 letters in the aflibercept arm. In LUCERNE, the average vision gains from baseline at two years were +5.0 letters in the Vabysmo arm and +5.2 letters in the aflibercept arm.

Furthermore, 59% (n=160/271) of Vabysmo patients in TENAYA and 67% (n=192/287) in LUCERNE achieved four-month dosing at two years. This is an increase over one-year results, which showed 46% (n=144/315) of Vabysmo patients in TENAYA and 45% (n=142/316) in LUCERNE achieved four-month dosing. An additional 15% (n=41/271) of Vabysmo patients in TENAYA and 14% (n=41/287) in LUCERNE achieved three-month dosing at two years. Combined, more than 78% of Vabysmo patients were able to go three months or longer between treatments at the end of the second year.

In both studies, comparable reductions in central subfield thickness (CST) were observed with Vabysmo given at intervals of up to four months versus aflibercept given every two months. Safety results were consistent across study arms, with no reported cases of retinal vasculitis or intraocular inflammation (IOI) associated with retinal vein or retinal artery occlusion.

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 AMD, and RHONE-X, an extension study of YOSEMITE and RHINE evaluating the long-term safety and tolerability of Vabysmo in DME. Additionally, the COMINO and BALATON trials are also underway, evaluating the efficacy and safety of Vabysmo in people with macular edema following retinal vein occlusion. Genentech has also initiated the Phase IV Elevatum study of Vabysmo in underrepresented patient populations with DME.

About the TENAYA and LUCERNE Studies

TENAYA (NCT03823287) and LUCERNE (NCT03823300) are two identical, randomized, multicenter, double-masked, global Phase III studies evaluating the efficacy and safety of Vabysmo compared to aflibercept in 1,329 people living with wet AMD (671 in TENAYA and 658 in LUCERNE). The studies each have two treatment arms: Vabysmo 6 mg administered at intervals of two, three or four months, following four initial monthly doses, selected based on objective assessment of disease activity as measured by optical coherence tomography and visual acuity evaluations at weeks 20 and 24; and aflibercept 2 mg administered at fixed two-month intervals after three initial monthly doses. At week 60, patients randomized to the Vabysmo arm were treated using a treat-and-extend approach up to week 108. Dosing schedule for Vabysmo patients during the treat-and-extend phase was adjusted based on treatment response as determined by central subfield thickness (CST) and visual acuity. In both arms, sham injections were administered at study visits when treatment injections were not scheduled to maintain the masking of investigators and participants.

The primary endpoint of the studies is 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, averaged over weeks 40, 44 and 48. Secondary endpoints include safety; the percentage of participants in the Vabysmo arm receiving treatment every two, three and four months; the percentage of participants achieving a gain, and the percentage avoiding a loss, of 15 letters or more in BCVA from baseline over time; and change in CST from baseline over time.

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 11 million people in the U.S. have some form of AMD, and of those, about 1.1 million have 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 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 during the first year, 25 out of 1,262 patients treated with Vabysmo reported such an event.

Adverse Reactions

The most common adverse reaction (≥5%) reported in patients receiving Vabysmo was 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.

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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