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FDA Approves Genentech’s Vabysmo Prefilled Syringe (PFS) for Three Leading Causes of Vision Loss

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The FDA has approved Genentech's Vabysmo prefilled syringe (PFS) for treating three major causes of vision loss: wet age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). Vabysmo PFS is the first syringe prefilled with an FDA-approved bispecific antibody aimed at retinal conditions, simplifying administration for retina specialists. This new format delivers the same 6.0 mg dose as the existing Vabysmo vials and will be available in the U.S. in the coming months. Vabysmo has shown significant improvements in vision and retinal drying and is already approved in over 95 countries.

Positive
  • FDA approval of Vabysmo PFS simplifies treatment for retina specialists, potentially increasing its adoption and market share.
  • Vabysmo PFS offers a ready-to-use format, enhancing user convenience and adherence.
  • The product addresses major vision loss causes, affecting nearly three million people in the U.S.
  • Vabysmo has demonstrated robust clinical efficacy in improving vision and retinal drying.
Negative
  • None

– Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness –

– Designed to simplify administration, Vabysmo PFS provides retina specialists a ready-to-use option –

– Vabysmo PFS will be available for people living with wet AMD, DME and RVO –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today the U.S. Food and Drug Administration (FDA) has approved the Vabysmo® (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect close to three million people in the U.S. The Vabysmo PFS will become available to U.S. retina specialists and their patients in the coming months.

The Vabysmo prefilled syringe, developed by Genentech, was approved by the FDA in July 2024. (Photo: Business Wire)

The Vabysmo prefilled syringe, developed by Genentech, was approved by the FDA in July 2024. (Photo: Business Wire)

“We are pleased that the U.S. FDA has approved the Vabysmo PFS for people living with wet AMD, DME and RVO, which are some of the leading causes of vision loss,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “While many retina specialists are already using Vabysmo as a first-line treatment, this new offering should make it even simpler to administer, thereby enhancing the treatment experience for both physicians and patients.”

Vabysmo PFS delivers the same medicine as the currently available Vabysmo vials in an alternative, ready-to-use format. Vabysmo will continue to be available in a 6.0 mg vial.

Vabysmo is the first and only bispecific antibody approved for the eye and has demonstrated rapid and robust vision improvements and retinal drying in wet AMD, DME and RVO. Retinal drying is an important clinical measure, as swelling from excess fluid in the back of the eye is associated with distorted and blurred vision.

To date, Vabysmo is approved in more than 95 countries for wet AMD and DME, and in several countries, including the U.S. and Japan, for RVO. Review by other health authorities across the globe is ongoing. More than four million doses of Vabysmo have been distributed globally since its initial U.S. approval in 2022.

Genentech is committed to helping people access the medicines they are prescribed and offers comprehensive services for people prescribed Vabysmo 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 Vabysmo.com for additional information.

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, 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.

Media Contact:

Shirley Dang, (650) 467-6800

Advocacy Contact:

Danielle Haney, (240) 805-4810

Investor Contacts:

Loren Kalm, (650) 225-3217

Bruno Eschli, +41 61 687 5284

Source: Genentech

FAQ

What is Vabysmo PFS?

Vabysmo PFS is a prefilled syringe with an FDA-approved bispecific antibody for treating wet AMD, DME, and RVO.

When was Vabysmo PFS approved by the FDA?

Vabysmo PFS was approved by the FDA in July 2024.

What conditions does Vabysmo PFS treat?

Vabysmo PFS treats wet AMD, diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO).

What is the benefit of using Vabysmo PFS?

Vabysmo PFS simplifies administration for retina specialists and improves the treatment experience for both physicians and patients.

Is Vabysmo available in other formats?

Yes, Vabysmo is also available in a 6.0 mg vial.

How has Vabysmo performed in clinical settings?

Vabysmo has shown rapid and robust improvements in vision and retinal drying.

How widely is Vabysmo approved globally?

Vabysmo is approved in more than 95 countries for various retinal conditions.

What support does Genentech offer for Vabysmo patients?

Genentech offers comprehensive services and patient assistance programs to minimize barriers to access and reimbursement.

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