2023
March
01,
2023
|
07:59 AM
Europe/Amsterdam
Submission to the Ministry of Health, Labor, and Welfare (MHLW) in Japan for aflibercept 8 mg in neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) is based on positive results of phase III clinical trials, PUL...
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February
06,
2023
|
10:59 AM
Europe/Amsterdam
Filing for aflibercept 8 mg in neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) is based on positive results of clinical trials, PULSAR and PHOTON / In both trials, aflibercept 8 mg demonstrated unprecedented...
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2022
November
11,
2022
|
14:52 PM
Europe/Amsterdam
Recommendation is based on the Phase III study FIREFLEYE and data from the follow-up study FIREFLEYE NEXT / Retinopathy of prematurity (ROP) can lead to severe visual impairment and blindness / Bayer will apply for a patent term extension for the pat...
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November
05,
2022
|
06:59 AM
Europe/Amsterdam
Aflibercept 8 mg maintained 16-week dosing intervals in up to 89% of patients with as few as 5 injections until week 48 / Aflibercept 8 mg demonstrated non-inferior vision gains to Eylea® (aflibercept 2 mg) with 83% of patients with neovascular (wet)...
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September
26,
2022
|
09:00 AM
Europe/Amsterdam
Approval is based on the Phase III study FIREFLEYE and data from the follow-up study FIREFLEYE NEXT / Retinopathy of prematurity (ROP) can lead to severe visual impairment and blindness / With ROP, Eylea® is now approved for six indications in Japan ...
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September
08,
2022
|
14:59 PM
Europe/Amsterdam
Aflibercept 8 mg meets primary endpoints in two global pivotal studies in neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) achieving non-inferior improvements in best corrected visual acuity to Eylea® (aflibe...
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2021
November
10,
2021
|
09:00 AM
Europe/Amsterdam
Berlin, November 10, 2021 - Bayer has filed applications for a new therapeutic indication for aflibercept (solution for injection) in premature babies with treatment-requiring retinopathy of prematurity (ROP) in the EU and Japan. "Our clinical develo...
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2020
February
10,
2020
|
08:30 AM
Europe/Amsterdam
Berlin, February 10, 2020 - Bayer and Regeneron Pharmaceuticals, Inc., today announced two planned phase III studies, PHOTON and PULSAR, evaluating extended treatment intervals with a new aflibercept 8mg formulation for intravitreal injection in adul...
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2019
June
21,
2019
|
11:15 AM
Europe/Amsterdam
Berlin, June 21, 2019 - Bayer has initiated a Phase III trial of its anti-VEGF treatment aflibercept for intravitreal injection in retinopathy of prematurity (ROP), an eye condition in premature infants which can lead to irreversible blindness.
ROP...
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2018
August
01,
2018
|
13:00 PM
Europe/Amsterdam
New treatment regimen could offer patients with neovascular age-related macular degeneration (AMD) extended proactive dosing already in the first year, while delivering strong visual gains / Data from ALTAIR study demonstrate sustainability of new ap...
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May
11,
2018
|
08:00 AM
Europe/Amsterdam
Eylea® gains approval in China for the treatment of visual impairment due to neovascular (wet) age-related macular degeneration...
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February
13,
2018
|
10:00 AM
Europe/Amsterdam
Eylea is the first anti-VEGF drug approved in China for the treatment of visual impairment due to diabetic macular edema in patients with DME...
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February
12,
2018
|
09:00 AM
Europe/Amsterdam
Data from ALTAIR study demonstrate injection appointments at an interval of 12 weeks or more / New data submitted to EMA to update the current product information...
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2017
August
30,
2017
|
09:00 AM
Europe/Amsterdam
Berlin, August 30, 2017 - Bayer announced today that over 50 abstracts featuring the latest research from its worldwide market-leading anti-vascular endothelial growth factor (anti-VEGF) treatment EYLEA® (aflibercept solution for injection into the e...
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