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Roche's (RHHBY) Vabysmo Gets Approval for nAMD & DME in Europe

Roche Holding AG RHHBY recently announced that the European Commission (EC) has approved Vabysmo (faricimab) for the treatment of neovascular or wet age-related macular degeneration (nAMD) as well as visual impairment due to diabetic macular edema (DME).

Per the company, Vabysmo is now the only injectable eye medicine, with phase III studies supporting treatment at intervals of up to four months for people living with nAMD and DME, to be approved in Europe.

The nod from EC was based on data from four phase III studies that evaluated Vabysmo for treating nAMD and DME, the two leading causes of vision loss worldwide. The TENAYA and LUCERNE studies evaluated Vabysmo for nAMD at year one while the YOSEMITE and RHINE studies evaluated Vabysmo for DME up to two years.

Data from the studies showed that treatment with Vabysmo, given at intervals of up to four months, achieved similar vision gains and anatomical improvements versus aflibercept given every two months.

Additionally, patients with nAMD and DME, who were under treatment with Vabysmo, received 33% and 21% fewer median number of injections compared to aflibercept, respectively, for up to two years.

Please note that aflibercept is marketed under the brand name Eylea.

Eylea is an anti-VEGF treatment developed by Regeneron REGN in collaboration with Bayer’s BAYRY HealthCare unit.

Regeneron/Bayer’s Eylea has been approved by the FDA for multiple retinal indications, including DME, wet AMD and retinal vein occlusion.

While REGN records net product sales of Eylea in the United States, BAYRY records net product sales of Eylea outside the country.

Shares of Roche have declined 18.1% this year compared with the industry’s decrease of 3.4%.

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In January 2022, Roche won FDA approval for Vabysmo for the treatment of nAMD and DME. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A.

Apart from the United States and European Union, Vabysmo is also approved in several other countries including the United Kingdom and Japan for treating nAMD and DME.

RHHBY is currently evaluating Vabysmo in various other studies. Other studies are also underway, which is evaluating the efficacy and safety of Vabysmo in people with macular edema following retinal vein occlusion.

Roche has also initiated the phase IV Elevatum study of Vabysmo in underrepresented patient populations with DME.

The approval of new drugs and label expansion of additional drugs bode well for the company.

Zacks Rank & Stock to Consider

Roche currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Aptose Biosciences Inc. APTO, which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aptose Biosciences’ loss per share estimates narrowed 14% for 2022 and 10% for 2023 in the past 60 days.

Earnings of Aptose Biosciences surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. APTO delivered an earnings surprise of 2.23%, on average.


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Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report
 
Roche Holding AG (RHHBY) : Free Stock Analysis Report
 
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