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Roche's (RHHBY) DME Drug Meets Primary Endpoint in Studies
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Roche (RHHBY - Free Report) announced positive top-line results from two identically designed late-stage studies on investigational bispecific antibody, faricimab.
The studies, YOSEMITE and RHINE, are evaluating faricimab in people living with diabetic macular edema (DME).
We note that the studies have three treatment arms, with participants randomized to receive either faricimab or aflibercept at fixed eight-week intervals, or faricimab at personalized intervals of up to 16 weeks, following a loading phase.
Both studies met their primary endpoints as results showed that faricimab given every eight weeks and at personalized dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to Regeneron Pharmaceuticals’ (REGN - Free Report) Eylea given every eight weeks.
The candidate was generally well-tolerated with no new safety signals identified.
More than half of participants in the faricimab personalized dosing arms achieved an extended time between treatments of 16 weeks at year one across both studies.
Whilst anti-vascular endothelial growth factor (VEGF) monotherapy injections have significantly reduced vision loss from DME, the burden of frequent eye injections and physician visits can lead to under-treatment and, potentially, less than optimal vision outcomes.
Faricimab is the first investigational bispecific antibody designed for the eye and targets two distinct pathways — via angiopoietin-2 (Ang-2) and VEGF-A.
The positive results from these late-stage studies showed that faricimab has the potential to offer lasting vision improvements for DME patients, while also reducing the treatment burden associated with frequent eye injections.
Meanwhile, the phase III Rhone-X study is investigating the long-term safety and tolerability of faricimab for the treatment of DME. The candidate is also being studied in the phase III TENAYA and LUCERNE studies as a potential treatment for neovascular or “wet” age-related macular degeneration (nAMD).
The successful development of the candidate will strengthen Roche’s ophthalmology franchise, which already includes Lucentis.
The stock has gained 8.2% in the year so far compared with the industry’s growth of 5.3%.
DME affects 21 million people globally representing significant potential.
However, competition is stiff in the space. Regeneron’s Eylea, a VEGF inhibitor, holds a dominant position in the DME market. Novartis’ (NVS - Free Report) Beovu is also being evaluated for DME.
Halozyme’s earnings estimates have grown 22 cents for 2020 and 26 cents for 2021 in the past 60 days.
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A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
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Roche's (RHHBY) DME Drug Meets Primary Endpoint in Studies
Roche (RHHBY - Free Report) announced positive top-line results from two identically designed late-stage studies on investigational bispecific antibody, faricimab.
The studies, YOSEMITE and RHINE, are evaluating faricimab in people living with diabetic macular edema (DME).
We note that the studies have three treatment arms, with participants randomized to receive either faricimab or aflibercept at fixed eight-week intervals, or faricimab at personalized intervals of up to 16 weeks, following a loading phase.
Both studies met their primary endpoints as results showed that faricimab given every eight weeks and at personalized dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to Regeneron Pharmaceuticals’ (REGN - Free Report) Eylea given every eight weeks.
The candidate was generally well-tolerated with no new safety signals identified.
More than half of participants in the faricimab personalized dosing arms achieved an extended time between treatments of 16 weeks at year one across both studies.
Whilst anti-vascular endothelial growth factor (VEGF) monotherapy injections have significantly reduced vision loss from DME, the burden of frequent eye injections and physician visits can lead to under-treatment and, potentially, less than optimal vision outcomes.
Faricimab is the first investigational bispecific antibody designed for the eye and targets two distinct pathways — via angiopoietin-2 (Ang-2) and VEGF-A.
The positive results from these late-stage studies showed that faricimab has the potential to offer lasting vision improvements for DME patients, while also reducing the treatment burden associated with frequent eye injections.
Meanwhile, the phase III Rhone-X study is investigating the long-term safety and tolerability of faricimab for the treatment of DME. The candidate is also being studied in the phase III TENAYA and LUCERNE studies as a potential treatment for neovascular or “wet” age-related macular degeneration (nAMD).
The successful development of the candidate will strengthen Roche’s ophthalmology franchise, which already includes Lucentis.
The stock has gained 8.2% in the year so far compared with the industry’s growth of 5.3%.
DME affects 21 million people globally representing significant potential.
However, competition is stiff in the space. Regeneron’s Eylea, a VEGF inhibitor, holds a dominant position in the DME market. Novartis’ (NVS - Free Report) Beovu is also being evaluated for DME.
Roche currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Halozyme Therapeutics, Inc. (HALO - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Halozyme’s earnings estimates have grown 22 cents for 2020 and 26 cents for 2021 in the past 60 days.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>