RETINAL VEIN OCCLUSION


Associated tags: Paratriathlon, Retina, Bleeding, Ischemia, CRVO, Central retinal vein occlusion, Ageing, Eye, BRVO, Macular edema, RVO, Biotechnology, Pharmaceutical, Optical, Clinical Trials, Pharmaceutical industry, Health, Ranibizumab, Food, Roche, ROG, FDA, Diabetic retinopathy, Genentech, Faricimab, Regulation of food and dietary supplements by the U.S. Food and Drug Administration

New Long-Term Data for Genentech’s Vabysmo Show Sustained Retinal Drying and Vision Improvements in Retinal Vein Occlusion (RVO)

Retrieved on: 
Thursday, February 1, 2024
Biotechnology, Health, Pharmaceutical, Optical, Clinical Trials, Paratriathlon, Inflammation, Ranibizumab, Research, Ophthalmology, RVO, Patient, Diabetic retinopathy, Swelling, CRVO, BRVO, Food, ROG, Bascom Palmer Eye Institute, Retina, Blood, Macular edema, Angiogenesis, Roche, Eye, CST, Telescopic sight

In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year.

Key Points: 
  • In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year.
  • Retinal drying is an important clinical measure as swelling from excess fluid in the back of the eye has been associated with distorted and blurred vision.
  • In both studies, Vabysmo was well tolerated and the safety profile was consistent with previous studies.
  • “The sustained vision improvements and retinal drying seen up to 72 weeks reaffirm Vabysmo as an effective treatment for retinal vein occlusion,” said Ramin Tadayoni, M.D., Ph.D., head of ophthalmology at Université Paris Cité in Paris and president of EURETINA, who is presenting the data at Angiogenesis.

FDA Approves Genentech’s Vabysmo for the Treatment of Retinal Vein Occlusion (RVO)

Retrieved on: 
Friday, October 27, 2023
FDA, Health, Clinical Trials, Pharmaceutical, Optical, Biotechnology, ROG, Food, Ranibizumab, RO, AMD, DME, Injection, Warning, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Inflammation, Retinal vasculitis, RVO, Diabetic retinopathy, Colic flexures, Paratriathlon, Vascular occlusion, Roche, Eye, Macular edema, Neovascularization, Pharmaceutical industry, Vaccine, Faricimab, Genentech

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Vabysmo® (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO).

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Vabysmo® (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO).
  • RVO is the third indication for Vabysmo, in addition to wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME).
  • Together, the three retinal conditions affect around 3 million people in the U.S. and are among the leading causes of vision loss.
  • This was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluid.

Genentech’s Vabysmo Maintained Vision Improvements With Extended Treatment Intervals Up to Four Months for People With Retinal Vein Occlusion (RVO) in Phase III Trials

Retrieved on: 
Tuesday, October 10, 2023
Research, FDA, Clinical Trials, Biotechnology, Managed Care, Health, Pharmaceutical, Optical, Science, Retina, Paratriathlon, European, HIV disease progression rates, RVO, Angiogenesis, Food, Neovascularization, Inflammation, DME, United Kingdom, Roche, ROG, CRVO, BRVO, AMD, Blood, Phase, RO, Faricimab, Diabetic retinopathy, Maintenance, Macular edema, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, European Medicines Agency, Pharmaceutical industry, Medical imaging, Vaccine, Genentech

Data showed people treated with Vabysmo extended their treatment intervals up to every four months while maintaining the vision gains achieved in the first 24 weeks of the trials.

Key Points: 
  • Data showed people treated with Vabysmo extended their treatment intervals up to every four months while maintaining the vision gains achieved in the first 24 weeks of the trials.
  • Vabysmo continued to show robust and sustained drying of retinal fluid from baseline up to week 72, as measured by reduction in central subfield thickness.
  • 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 both global Phase III BRVO and CRVO trials.
  • In both studies, Vabysmo was generally well-tolerated and the safety profile was consistent with previous trials.

Promising signals of effect in Annexin's RVO-study

Retrieved on: 
Friday, August 11, 2023
Retina, Comment, Medicine, Diagnosis, Ophthalmology, Ranibizumab, Visual acuity, Patient, Standard of care, RVO, Safety, Disease, Pharmaceutical industry, Annexin

A group of leading independent US ophthalmologists has conducted an evaluation of the available information from patients treated so far in the placebo-controlled study.

Key Points: 
  • A group of leading independent US ophthalmologists has conducted an evaluation of the available information from patients treated so far in the placebo-controlled study.
  • The evaluation confirmed an unexpectedly long duration of effect with a single dose of standard of care anti-VEGF treatment in two of five treated patients.
  • The unmasking showed that the two patients with potential signals of effect had received ANXV.
  • No clear signals of effect were observed in the other patients in the study where two had received ANXV and one had received placebo.

Promising signals of effect in Annexin's RVO-study

Retrieved on: 
Friday, August 11, 2023
Retina, Comment, Medicine, Diagnosis, Ophthalmology, Ranibizumab, Visual acuity, Patient, Standard of care, RVO, Safety, Disease, Pharmaceutical industry, Annexin

A group of leading independent US ophthalmologists has conducted an evaluation of the available information from patients treated so far in the placebo-controlled study.

Key Points: 
  • A group of leading independent US ophthalmologists has conducted an evaluation of the available information from patients treated so far in the placebo-controlled study.
  • The evaluation confirmed an unexpectedly long duration of effect with a single dose of standard of care anti-VEGF treatment in two of five treated patients.
  • The unmasking showed that the two patients with potential signals of effect had received ANXV.
  • No clear signals of effect were observed in the other patients in the study where two had received ANXV and one had received placebo.

FDA Accepts Application for Genentech’s Vabysmo for the Treatment of Retinal Vein Occlusion (RVO)

Retrieved on: 
Tuesday, May 9, 2023
FDA, Health, Clinical Trials, Pharmaceutical, Optical, Biotechnology, Ranibizumab, DME, RVO, AMD, European Medicines Agency, Eye, Roche, Neovascularization, Diabetic retinopathy, ROG, RO, European, Macular edema, United Kingdom, Paratriathlon, Phase, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Macular degeneration, Food, Disease, Pharmaceutical industry, Faricimab, Genentech

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO).

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO).
  • The studies are ongoing, and data from weeks 24 to 72 will assess the potential of Vabysmo to extend dosing intervals up to every four months.
  • Vabysmo is approved in 60 countries, including Japan, the United Kingdom, and in the European Union, for wet AMD and DME.
  • It targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).

New Phase III Data Show Genentech’s Vabysmo Rapidly Improved Vision and Reduced Retinal Fluid in People With Retinal Vein Occlusion (RVO)

Retrieved on: 
Friday, February 10, 2023
Health, FDA, Other Health, Clinical Trials, Pharmaceutical, Optical, Biotechnology, CST, Paratriathlon, Ranibizumab, Fluid, RO, CRVO, DME, Swelling, Safety, AMD, Patient, Eye, Retina, Food, Angiogenesis, European Medicines Agency, Diabetic retinopathy, Macular edema, Retinal scan, Bascom Palmer Eye Institute, RVO, Injection, ROG, BRVO, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Roche, Pharmaceutical industry, Birth control, Genentech, Faricimab

Vabysmo also showed rapid and robust drying of retinal fluid from baseline, as measured by reduction in central subfield thickness.

Key Points: 
  • Vabysmo also showed rapid and robust drying of retinal fluid from baseline, as measured by reduction in central subfield thickness.
  • Results will be presented virtually on February 11 at Angiogenesis, Exudation, and Degeneration 2023, organized by Bascom Palmer Eye Institute in Florida.
  • “These encouraging results reinforce the potential of Vabysmo as a new treatment option for people experiencing vision loss associated with retinal vein occlusion,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development.
  • In COMINO, vision gains were +16.9 letters in the Vabysmo arm and +17.3 letters in the aflibercept arm at 24 weeks.

Positive Topline Phase III Results Show Genentech’s Vabysmo Improved Vision for People Living With Retinal Vein Occlusion (RVO)

Retrieved on: 
Thursday, October 27, 2022
Research, FDA, Diabetes, Clinical Trials, Biotechnology, Health, Pharmaceutical, Optical, Science

Vabysmo also showed rapid drying of retinal fluid from baseline through week 24, as measured by reduction in central subfield thickness.

Key Points: 
  • Vabysmo also showed rapid drying of retinal fluid from baseline through week 24, as measured by reduction in central subfield thickness.
  • Detailed results will be presented at an upcoming medical meeting and submitted to regulatory authorities around the world.
  • Vabysmo targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).
  • Retinal vein occlusion (RVO) is the second most common cause of vision loss due to retinal vascular diseases.