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Roche (RHHBY) Announces 2-Year Data on Vabysmo for nAMD
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Roche (RHHBY - Free Report) has announced new two-year data from the TENAYA and LUCERNE studies on ophthalmology drug Vabysmo (faricimab).
The data reinforce the long-term efficacy, safety and durability of Vabysmo in neovascular or “wet” age-related macular degeneration (nAMD).
The data was presented at the 2022 American Society of Retina Specialists Annual Scientific Meeting.
Data from both the studies at two years showed that more than 60% of people receiving Vabysmo could be treated every four months – an increase of more than 15 percentage points since the primary analysis at one year while achieving comparable vision gains versus Regeneron’s (REGN - Free Report) Eylea (aflibercept) given every two months. Almost 80% of people receiving Vabysmo could be treated every three months or longer.
Eylea is one of the leading drugs in this market and the primary growth driver for Regeneron.
Moreover, patients treated with Vabysmo received a median number of 10 injections over the two years compared with 15 for those patients treated with Eylea, 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.
Vabysmo is approved in the United States and Japan for diabetic macular edema (DME). Vabysmo is currently under review in the European Union for these conditions.
Roche’s stock has lost 18.8% in the year against the industry’s growth of 3.6%.
Image Source: Zacks Investment Research
RHHBY is currently evaluating Vabysmo in various other studies. This includes AVONELLE-X, an extension study of TENAYA and LUCERNE evaluating the long-term safety and tolerability of Vabysmo in nAMD, and RHONE-X, an extension study of YOSEMITE and RHINE evaluating the long-term safety and tolerability of Vabysmo in DME. Two more studies are also underway, 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.
Approval of new drugs and label expansion of additional drugs bode well for the company.
Roche’s performance in the March quarter was encouraging on the back of its diagnostics division, which maintained its stellar performance on demand for conducting COVID-19 tests. The pharmaceuticals business was also stable and newer drugs continued to offset the decline in sales of the legacy drugs.
However, the outlook indicated that sales will decline in 2022 from the prior-year reported figure due to reduced demand for COVID-19 medicines and diagnostics.
ALKS’ loss estimates for 2022 have narrowed to 3 cents from a loss of 14 cents in the past 60 days. Alkermes surpassed earnings in all the trailing four quarters, the average being 350.48%.
Sarepta’s loss per share estimates for 2022 have narrowed by 61 cents in the past 90 days. SRPT’s earnings have surpassed expectations in all of the trailing four quarters, the average surprise being 21.45%.
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Roche (RHHBY) Announces 2-Year Data on Vabysmo for nAMD
Roche (RHHBY - Free Report) has announced new two-year data from the TENAYA and LUCERNE studies on ophthalmology drug Vabysmo (faricimab).
The data reinforce the long-term efficacy, safety and durability of Vabysmo in neovascular or “wet” age-related macular degeneration (nAMD).
The data was presented at the 2022 American Society of Retina Specialists Annual Scientific Meeting.
Data from both the studies at two years showed that more than 60% of people receiving Vabysmo could be treated every four months – an increase of more than 15 percentage points since the primary analysis at one year while achieving comparable vision gains versus Regeneron’s (REGN - Free Report) Eylea (aflibercept) given every two months. Almost 80% of people receiving Vabysmo could be treated every three months or longer.
Eylea is one of the leading drugs in this market and the primary growth driver for Regeneron.
Moreover, patients treated with Vabysmo received a median number of 10 injections over the two years compared with 15 for those patients treated with Eylea, 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.
Vabysmo is approved in the United States and Japan for diabetic macular edema (DME). Vabysmo is currently under review in the European Union for these conditions.
Roche’s stock has lost 18.8% in the year against the industry’s growth of 3.6%.
Image Source: Zacks Investment Research
RHHBY is currently evaluating Vabysmo in various other studies. This includes AVONELLE-X, an extension study of TENAYA and LUCERNE evaluating the long-term safety and tolerability of Vabysmo in nAMD, and RHONE-X, an extension study of YOSEMITE and RHINE evaluating the long-term safety and tolerability of Vabysmo in DME. Two more studies are also underway, 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.
Approval of new drugs and label expansion of additional drugs bode well for the company.
Roche’s performance in the March quarter was encouraging on the back of its diagnostics division, which maintained its stellar performance on demand for conducting COVID-19 tests. The pharmaceuticals business was also stable and newer drugs continued to offset the decline in sales of the legacy drugs.
However, the outlook indicated that sales will decline in 2022 from the prior-year reported figure due to reduced demand for COVID-19 medicines and diagnostics.
Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold). A few better-ranked stocks are Alkermes (ALKS - Free Report) and Sarepta (SRPT - Free Report) . While Alkermes sports a Zacks Rank #1 (Strong Buy), Sarepta has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
ALKS’ loss estimates for 2022 have narrowed to 3 cents from a loss of 14 cents in the past 60 days. Alkermes surpassed earnings in all the trailing four quarters, the average being 350.48%.
Sarepta’s loss per share estimates for 2022 have narrowed by 61 cents in the past 90 days. SRPT’s earnings have surpassed expectations in all of the trailing four quarters, the average surprise being 21.45%.