FDA accepts application for Roche ’s Vabysmo for the treatment of retinal vein occlusion (RVO)
Acceptance based on two phase III studies that demonstrated early and sustained vision improvement with Vabysmo, meeting primary endpoint of non-inferiority compared to afliberceptApplication was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluidIf approved, RVO would be the third indication for Vabysmo in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME)Vabysmo is currently approved in 60 countries to treat nAMD and DME, with nearly one million doses distributed globallyBasel, 9 May 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY...
Source: Roche Investor Update - May 9, 2023 Category: Pharmaceuticals Source Type: news
FDA accepts application for Roche ’s Vabysmo for the treatment of retinal vein occlusion (RVO)
Acceptance based on two phase III studies that demonstrated early and sustained vision improvement with Vabysmo, meeting primary endpoint of non-inferiority compared to afliberceptApplication was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluidIf approved, RVO would be the third indication for Vabysmo in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME)Vabysmo is currently approved in 60 countries to treat nAMD and DME, with nearly one million doses distributed globallyBasel, 9 May 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY...
Source: Roche Media News - May 9, 2023 Category: Pharmaceuticals Source Type: news
New Vabysmo data suggest greater retinal drying versus aflibercept in nAMD and DME
Post-hoc analyses from four phase III studies indicate Vabysmo dried retinal fluid faster with fewer injections in neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME)More Vabysmo patients with nAMD had absence of retinal fluid at 12 weeks in a post-hoc analysis from the phase III TENAYA and LUCERNE studiesDME patients treated with Vabysmo had less blood vessel leakage in the macula at 16 weeks in a post-hoc analysis from the phase III YOSEMITE and RHINE studiesBasel, 25 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that post-hoc data indicate treatment with Va...
Source: Roche Investor Update - April 25, 2023 Category: Pharmaceuticals Source Type: news
New Vabysmo data suggest greater retinal drying versus aflibercept in nAMD and DME
Post-hoc analyses from four phase III studies indicate Vabysmo dried retinal fluid faster with fewer injections in neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME)More Vabysmo patients with nAMD had absence of retinal fluid at 12 weeks in a post-hoc analysis from the phase III TENAYA and LUCERNE studiesDME patients treated with Vabysmo had less blood vessel leakage in the macula at 16 weeks in a post-hoc analysis from the phase III YOSEMITE and RHINE studiesBasel, 25 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that post-hoc data indicate treatment with Va...
Source: Roche Media News - April 25, 2023 Category: Pharmaceuticals Source Type: news
Roche data highlights strength of ophthalmology portfolio and commitment to advancing eye care at ARVO 2023
Vabysmo data suggest rapid and robust drying of retinal fluid in patients withneovascular or ‘wet’ age-related macular degeneration and diabetic macular edemaReal-world studies ofVabysmo demonstrate ability to extend treatment intervals in the first four months while maintaining visual acuityClinical data on an investigational anti-interleukin-6 treatment inuveitic macular edema will be presented for the first timeBasel, 13 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data for its approved and investigational medicines will be highlighted in 30 abstracts at the 2023 Association for Research ...
Source: Roche Media News - April 13, 2023 Category: Pharmaceuticals Source Type: news
Roche data highlights strength of ophthalmology portfolio and commitment to advancing eye care at ARVO 2023
Vabysmo data suggest rapid and robust drying of retinal fluid in patients withneovascular or ‘wet’ age-related macular degeneration and diabetic macular edemaReal-world studies ofVabysmo demonstrate ability to extend treatment intervals in the first four months while maintaining visual acuityClinical data on an investigational anti-interleukin-6 treatment inuveitic macular edema will be presented for the first timeBasel, 13 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data for its approved and investigational medicines will be highlighted in 30 abstracts at the 2023 Association for Research ...
Source: Roche Investor Update - April 13, 2023 Category: Pharmaceuticals Source Type: news
New phase III data show Roche ’s Vabysmo rapidly improved vision and reduced retinal fluid in people with retinal vein occlusion (RVO)
Vabysmo met its primary endpoint in two clinical trials, BALATON and COMINO, showing non-inferior visual acuity gains compared toafliberceptMoreVabysmo patients showed an absence of blood vessel leakage in the retina compared toaflibercept in a pre-specified exploratory endpointIf approved, RVO would be the third indication forVabysmo in addition toneovascular or ‘wet’ age-related macular degeneration and diabetic macular edemaBasel, 10 February 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive new data from two global phase III studies, BALATON and COMINO, evaluating Vabysmo ® (faricimab) in macular ...
Source: Roche Media News - February 10, 2023 Category: Pharmaceuticals Source Type: news
New phase III data show Roche ’s Vabysmo rapidly improved vision and reduced retinal fluid in people with retinal vein occlusion (RVO)
Vabysmo met its primary endpoint in two clinical trials, BALATON and COMINO, showing non-inferior visual acuity gains compared toafliberceptMoreVabysmo patients showed an absence of blood vessel leakage in the retina compared toaflibercept in a pre-specified exploratory endpointIf approved, RVO would be the third indication forVabysmo in addition toneovascular or ‘wet’ age-related macular degeneration and diabetic macular edemaBasel, 10 February 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive new data from two global phase III studies, BALATON and COMINO, evaluating Vabysmo ® (faricimab) in macular ...
Source: Roche Investor Update - February 10, 2023 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good results for 2022 despite decline in demand for COVID-19 products
Group sales grow by 2%1 at constant exchange rates (CER) and 1% in Swiss francs, despite lower COVID-19-related sales in both divisionsPharmaceuticals Division salesincrease by 2%; continued strong growth of newer medicines more than compensating for the impact of biosimilars and lower sales of Actemra/RoActemra (severe COVID-19)Diagnostics Division salesgrow by 3%; ongoing strong momentum in base business (+7%) more than compensating for the continuing decline in the demand for COVID-19 tests in the second half of the yearHighlightsin the fourth quarter of 2022 (incl. January 2023):US approvals ofLunsumio (follicular lymp...
Source: Roche Investor Update - February 2, 2023 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good results for 2022 despite decline in demand for COVID-19 products
Basel, 2 February 2023Group sales grow by 2%1 at constant exchange rates (CER) and 1% in Swiss francs, despite lower COVID-19-related sales in both divisionsPharmaceuticals Division salesincrease by 2%; continued strong growth of newer medicines more than compensating for the impact of biosimilars and lower sales of Actemra/RoActemra (severe COVID-19)Diagnostics Division salesgrow by 3%; ongoing strong momentum in base business (+7%) more than compensating for the continuing decline in the demand for COVID-19 tests in the second half of the yearHighlightsin the fourth quarter of 2022 (incl. January 2023):US approvals ofLun...
Source: Roche Media News - February 2, 2023 Category: Pharmaceuticals Source Type: news
Positive topline phase III results show Roche's Vabysmo improved vision for people living with retinal vein occlusion (RVO)
Vabysmo achieved its primary endpoint of non-inferiority toaflibercept in RVO in the BALATON and COMINO clinical trialsVabysmo was generally well tolerated, with a safety profile consistent with previous trialsVabysmo is the first and only treatment that targets and inhibits two disease pathways involving Ang-2 and VEGF-A, linked to a number of vision-threatening retinal conditionsDetailed results will be presented at an upcoming medical meeting and submitted to regulatory authorities around the worldBasel, 27 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two global phase I...
Source: Roche Investor Update - October 27, 2022 Category: Pharmaceuticals Source Type: news
Positive topline phase III results show Roche's Vabysmo improved vision for people living with retinal vein occlusion (RVO)
Vabysmo achieved its primary endpoint of non-inferiority toaflibercept in RVO in the BALATON and COMINO clinical trialsVabysmo was generally well tolerated, with a safety profile consistent with previous trialsVabysmo is the first and only treatment that targets and inhibits two disease pathways involving Ang-2 and VEGF-A, linked to a number of vision-threatening retinal conditionsDetailed results will be presented at an upcoming medical meeting and submitted to regulatory authorities around the worldBasel, 27 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two global phase I...
Source: Roche Media News - October 27, 2022 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche records solid results for the first nine months of 2022
Group salesup 2%[1] at constant exchange rates (CER) and 1% in Swiss francs; as expected, significantly lower COVID-19-related sales in both divisions in the third quarterSales in the Pharmaceuticals Divisionat the previous year ’s level with significantly lower sales of COVID-19-related products (Ronapreve and Actemra/RoActemra) and losses to biosimilars, offset by strong growth of newer medicinesSales in the Diagnostics Divisionrise 6%; base business remains strong; as expected, demand for COVID-19 tests sharply down in third quarterHighlights in the third quarter:EU approval forVabysmo (severe eye diseases)US approval...
Source: Roche Investor Update - October 18, 2022 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche records solid results for the first nine months of 2022
Basel, 18 October 2022Group salesup 2%1 at constant exchange rates (CER) and 1% in Swiss francs; as expected, significantly lower COVID-19-related sales in both divisions in the third quarterSales in the Pharmaceuticals Divisionat the previous year ’s level with significantly lower sales of COVID-19-related products (Ronapreve and Actemra/RoActemra) and losses to biosimilars, offset by strong growth of newer medicinesSales in the Diagnostics Divisionrise 6%; base business remains strong; as expected, demand for COVID-19 tests sharply down in third quarterHighlights in the third quarter:EU approval forVabysmo (severe eye ...
Source: Roche Media News - October 18, 2022 Category: Pharmaceuticals Source Type: news
European Commission approves Roche ’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
Phase III data that showed people with nAMD and DME treated with Vabysmo up to every four months achieved similar outcomes compared to receiving treatment every two months with afliberceptIn addition, patients treated with Vabysmo received up to 33% fewer median number of injections compared to afliberceptReducing the number of eye injections over time could offer a less burdensome treatment schedule for individuals, their caregivers and healthcare systemsVabysmo simultaneously targets and inhibits two disease pathways involving Ang-2 and VEGF-A linked to a number of vision-threatening retinal conditionsBasel, 19 September...
Source: Roche Investor Update - September 19, 2022 Category: Pharmaceuticals Source Type: news
