New data from pivotal studies with aflibercept 8 mg
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 presentations on aflibercept 8 mg and Eylea (aflibercept 2 mg) reinforce Bayer’s commitment to advancing treatment of patients with exudative retinal disease
Bayer and its collaborator Regeneron will present new clinical data analyses for the investigational formulation aflibercept 8 mg at the Annual Meeting of The Association for Research in Vision and Ophthalmology (arvo.org) 2023, in New Orleans, Louisiana, 23-27 April 2023. The data will highlight Bayer’s commitment to advancing the unmet need of extended treatment intervals in exudative retinal disease. New subgroup and further analyses of the pivotal studies PULSAR, PHOTON and CANDELA will provide further insights into durability results of extended treatment intervals, patient characteristics as well as efficacy and safety of aflibercept 8 mg versus aflibercept 2 mg (EyleaTM) in patients with neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular degeneration (DME).
The following new abstracts for aflibercept 8 mg will be presented at ARVO 2023:
The pooled safety analysis compares the safety of aflibercept 8 mg with aflibercept 2 mg across the clinical trial program which includes data from the phase II trial CANDELA in nAMD and the pivotal phase II/III trial PHOTON in DME and the phase III trial PULSAR in nAMD.
· Pooled Safety Analysis of Aflibercept 8 mg in the CANDELA, PHOTON, and PULSAR Trials
o Poster presentation # 3724 – C0501
o April 25, 2023; 15.30-17.15 EST
The analysis of the phase III trial PULSAR reports safety and tolerability outcomes of aflibercept 8 mg every 12 or 16 weeks versus aflibercept 2 mg every 8 weeks through to week 48.
· Tolerability and safety of intravitreal aflibercept 8 mg in the phase III PULSAR trial of patients with neovascular (wet) age-related macular degeneration
o Poster presentation # 278 – C0115
o April 23, 2023; 8.00-9.45 EST
The post-hoc analysis of the phase III trial PULSAR describes baseline characteristics of patients maintained on their original randomized dosing regimens of aflibercept 8 mg every 12 or 16 weeks or aflibercept 2 mg every 8 weeks versus those who had shortened intervals according to prespecified dose regimen modification criteria denoting disease activity.
· Baseline disease characteristics in patients maintaining q12 and q16 dosing with aflibercept 8 mg versus patients with shortened treatment intervals: A Phase 3 PULSAR post hoc analysis
o Poster presentation # 2238-C0192
o April 24, 2023; 15.15-17.00 EST
In a subgroup analysis from the phase III trial PULSAR the treatment effect on the primary endpoint in patients with treatment-naïve nAMD was determined for clinically relevant subgroups by baseline BCVA, central retinal thickness (CRT) or lesion type.
· Subgroup analyses from the Phase 3 PULSAR trial of aflibercept 8 mg in patients with treatment-naïve neovascular age-related macular degeneration
o Poster presentation # 2239 – C0191
o April 24, 2023; 15.15-17.00 EST
The analysis of the PHOTON trial evaluates baseline clinical characteristics of patients with diabetic macular edema (DME) who received intravitreal aflibercept 8 mg and maintained their randomized dosing intervals versus those whose intervals were shortened after meeting prespecified criteria through Week 48.
· Baseline Disease Characteristics of Patients Who Maintained 12- and 16-Week Aflibercept 8 mg Dosing Versus Patients with Shortened Treatment Intervals Through Week 48 in the Phase 2/3 PHOTON Trial
o Podium presentation
o April 25, 2023; 12.15-12.30 EST
The analysis of the PHOTON trial evaluates the treatment effects of aflibercept 8 mg versus 2 mg at Week 48 in patients with diabetic macular edema (DME) by baseline demographics.
· Intravitreal Aflibercept 8 mg for Diabetic Macular Edema: Week 48 Efficacy Outcomes by Baseline Demographics in the Phase 2/3 PHOTON Trial
o Poster presentation # 2707 – B0529
o April 25, 2023; 8.45-10.30 EST
Aflibercept 8 mg is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea and aflibercept 8 mg in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea.
Aflibercept 8 mg is investigational, and its safety and efficacy have not yet been evaluated by any regulatory authority.
About aflibercept 8 mg
Aflibercept 8 mg has been developed with the aim to increase intervals between injections without compromising vision gains. Aflibercept 8 mg was investigated in neovascular (wet) age-related macular degeneration (PULSAR) and diabetic macular edema (PHOTON) to evaluate efficacy and safety compared to Eylea (aflibercept 2 mg).
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