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Roche's (RHHBY) Vabysmo Positive in Late-Stage RVO Studies
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Roche (RHHBY - Free Report) announced positive top-line long-term results from two global late-stage studies on the ophthalmology drug Vabysmo (faricimab).
The phase III BALATON and COMINO studies are evaluating the efficacy and safety of Vabysmo compared with aflibercept. The BALATON study was conducted in 553 people with branch retinal vein occlusion (BRVO). The COMINO study was conducted in 729 people with central retinal or hemi retinal vein occlusion (CRVO).
Patients were randomized 1:1 to receive six-monthly injections of either Vabysmo (6.0 mg) or aflibercept (2.0 mg) for the first 20 weeks. All patients received Vabysmo (6.0 mg) up to every four months, using a treat-and-extend dosing regimen from weeks 24 to 72.
The top-line data showed that treatment with Vabysmo helped people extend their treatment intervals up to every four months and their vision gains achieved in the first 24 weeks of the studies were maintained as well. Vabysmo continued to show robust and sustained drying of retinal fluid from baseline up to week 72, as measured by a reduction in central subfield thickness.
Vabysmo was generally well-tolerated and the safety profile was consistent with previous studies in both studies.
Data from the first 24 weeks of the phase III BALATON and COMINO studies earlier demonstrated early and sustained vision improvement with Vabysmo. Both studies met their primary endpoints of non-inferior vision gains compared with aflibercept. A secondary endpoint showed that Vabysmo achieved rapid and robust drying of retinal fluid from baseline to week 24, as measured by a reduction in central subfield thickness.
Data for up to 24 weeks has been submitted to the FDA and European Medicines Agency. A decision from the FDA is expected in late 2023.
We note that Vabysmo is currently approved for the treatment of people living with ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).
A potential approval for retinal vein occlusion (RVO) will be the third indication for which the drug will be approved. Per Roche, this is the first time that vision and anatomical improvements have been maintained for more than a year using a personalized treat-and-extend dosing regimen in phase III studies for both BRVO and CRVO.
RVO is the second most common cause of vision loss due to retinal vascular diseases.
Roche’s stock has declined 21.3% in the year-to-date period compared with the industry’s decline of 19.8%.
Image Source: Zacks Investment Research
Vabysmo has witnessed outstanding uptake in nAMD and DME, posing stiff competition to aflibercept.
Please note that aflibercept is approved under the brand name Eylea.
Regeneron (REGN - Free Report) codeveloped Eylea with Bayer (BAYRY - Free Report) . The FDA earlier approved aflibercept 8 mg for the treatment of patients with wAMD, diabetic macular edema and diabetic retinopathy under the brand name Eylea HD.
Regeneron owns exclusive rights to Eylea and Eylea HD. Bayer has licensed exclusive marketing rights outside of the United States, where both companies equally share profits from sales of Eylea.
Eylea had been a consistent performer for Regeneron, but sales in the last few quarters have been under pressure due to increasing competition from Vabysmo for wAMD and DME. The approval of Eylea HD will somewhat offset this decline.
The stellar performance of Vabysmo, along with Ocrevus, Hemlibra, Evrysdi and Tecentriq, boosted growth for Roche in the first half amid declining COVID-19-related sales.
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 51 cents in the past 90 days, while earnings estimates for 2024 are pinned at 3 cents per share.
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Roche's (RHHBY) Vabysmo Positive in Late-Stage RVO Studies
Roche (RHHBY - Free Report) announced positive top-line long-term results from two global late-stage studies on the ophthalmology drug Vabysmo (faricimab).
The phase III BALATON and COMINO studies are evaluating the efficacy and safety of Vabysmo compared with aflibercept. The BALATON study was conducted in 553 people with branch retinal vein occlusion (BRVO). The COMINO study was conducted in 729 people with central retinal or hemi retinal vein occlusion (CRVO).
Patients were randomized 1:1 to receive six-monthly injections of either Vabysmo (6.0 mg) or aflibercept (2.0 mg) for the first 20 weeks. All patients received Vabysmo (6.0 mg) up to every four months, using a treat-and-extend dosing regimen from weeks 24 to 72.
The top-line data showed that treatment with Vabysmo helped people extend their treatment intervals up to every four months and their vision gains achieved in the first 24 weeks of the studies were maintained as well. Vabysmo continued to show robust and sustained drying of retinal fluid from baseline up to week 72, as measured by a reduction in central subfield thickness.
Vabysmo was generally well-tolerated and the safety profile was consistent with previous studies in both studies.
Data from the first 24 weeks of the phase III BALATON and COMINO studies earlier demonstrated early and sustained vision improvement with Vabysmo. Both studies met their primary endpoints of non-inferior vision gains compared with aflibercept. A secondary endpoint showed that Vabysmo achieved rapid and robust drying of retinal fluid from baseline to week 24, as measured by a reduction in central subfield thickness.
Data for up to 24 weeks has been submitted to the FDA and European Medicines Agency. A decision from the FDA is expected in late 2023.
We note that Vabysmo is currently approved for the treatment of people living with ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).
A potential approval for retinal vein occlusion (RVO) will be the third indication for which the drug will be approved. Per Roche, this is the first time that vision and anatomical improvements have been maintained for more than a year using a personalized treat-and-extend dosing regimen in phase III studies for both BRVO and CRVO.
RVO is the second most common cause of vision loss due to retinal vascular diseases.
Roche’s stock has declined 21.3% in the year-to-date period compared with the industry’s decline of 19.8%.
Image Source: Zacks Investment Research
Vabysmo has witnessed outstanding uptake in nAMD and DME, posing stiff competition to aflibercept.
Roche Holding AG Price and Consensus
Roche Holding AG price-consensus-chart | Roche Holding AG Quote
Please note that aflibercept is approved under the brand name Eylea.
Regeneron (REGN - Free Report) codeveloped Eylea with Bayer (BAYRY - Free Report) . The FDA earlier approved aflibercept 8 mg for the treatment of patients with wAMD, diabetic macular edema and diabetic retinopathy under the brand name Eylea HD.
Regeneron owns exclusive rights to Eylea and Eylea HD. Bayer has licensed exclusive marketing rights outside of the United States, where both companies equally share profits from sales of Eylea.
Eylea had been a consistent performer for Regeneron, but sales in the last few quarters have been under pressure due to increasing competition from Vabysmo for wAMD and DME. The approval of Eylea HD will somewhat offset this decline.
The stellar performance of Vabysmo, along with Ocrevus, Hemlibra, Evrysdi and Tecentriq, boosted growth for Roche in the first half amid declining COVID-19-related sales.
Zacks Rank & Stock to Consider
Roche currently carries a Zacks Rank #4 (Sell).
A better-ranked stock in the healthcare industry is Dynavax Technologies (DVAX - Free Report) , which currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 51 cents in the past 90 days, while earnings estimates for 2024 are pinned at 3 cents per share.