2023
September
28,
2023
|
08:29 AM
Europe/Amsterdam
Presentations at EURETINA capture 60-week data, a key secondary endpoint, and two-year data (96-week) from the pivotal PULSAR and PHOTON clinical trials that provide insights into durability of extended treatment intervals as well as efficacy and saf...
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August
10,
2023
|
12:59 PM
Europe/Amsterdam
Results from PULSAR demonstrate long term efficacy of aflibercept 8 mg with extended dosing intervals reaching up to 24 weeks and vision improvements comparable to Eylea™ (aflibercept 2 mg) at fixed 8-weekly dosing over two years / Patients randomize...
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June
29,
2023
|
08:29 AM
Europe/Amsterdam
Data from pivotal PHOTON trial demonstrate long term efficacy of aflibercept 8 mg with extended intervals comparable to EyleaTM (aflibercept 2 mg) at fixed 8-weekly dosing over two years / Patients assigned to a 16-week dosing regimen at baseline rec...
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May
10,
2023
|
09:59 AM
Europe/Amsterdam
Global phase III QUASAR study will assess the efficacy and safety of aflibercept 8 mg in macular edema secondary to retinal vein occlusion (RVO) / Study comes after positive data from the phase III PULSAR trial in neovascular (wet) age-related macula...
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April
17,
2023
|
12:59 PM
Europe/Amsterdam
New Subgroup and further analyses from PULSAR, PHOTON and CANDELA provide insights into durability results of extended treatment intervals, patient characteristics as well as efficacy and safety of intravitreal aflibercept 8 mg / In total, 18 present...
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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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