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Bayer’s New data from pivotal studies with aflibercept 8 mg

April 17, 2023: “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.

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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).

About PULSAR, PHOTON and CANDELA
PULSAR and PHOTON are double-masked, active-controlled pivotal trials. Both trials were conducted in multiple centers globally with similar designs and endpoints.

The Phase III PULSAR trial in nAMD and Phase II/III PHOTON trial in DME evaluated the efficacy and safety of aflibercept 8 mg with 12- and 16-week dosing regimens versus Eylea (aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses, with the primary endpoint of non-inferiority in terms of best corrected visual acuity (BCVA) at week 48.

Patients in both clinical trials were randomized at baseline and assigned to the three different arms.

Across both studies, 1,164 patients were treated with aflibercept 8 mg. All patients in the aflibercept 8 mg arms were continuously evaluated under stringent, clinically relevant, patient focused dose regimen modification (DRM) criteria starting from week 16 throughout the study.

In the first year, patients in the aflibercept 8 mg groups could have their dosing intervals shortened down to an every 8-week interval if DRM criteria for disease progression were observed.

Intervals could not be extended until the second year of the study, with those results still to be assessed.

Patients in all Eylea groups maintained a fixed 8-week dosing regimen throughout their participation in the trials.

CANDELA was a Phase II trial investigating aflibercept 8 mg with regards to safety and efficacy and to determine if aflibercept 8 mg provides longer durability compared to Eylea (aflibercept 2 mg) in patients with nAMD.

About nAMD and DME
Neovascular (wet) age-related macular degeneration (nAMD) is an eye disease that progresses rapidly and if left untreated can lead to vision loss in as little as three months.

nAMD is one of the leading causes of irreversible blindness and vision impairment around the world.

nAMD may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail.

This fluid can damage and scar the macula, which can cause vision loss. 196 million people worldwide are living with AMD – it is anticipated that this figure will increase to 288 million by 2040.

Diabetic macular edema (DME) is a common complication in eyes of people living with diabetes. DME occurs when high levels of blood sugar lead to damaged blood vessels in the eye that leak fluid into the macula.

This can lead to vision loss and, in some cases, blindness. Globally, 146 million people are currently living with diabetic retinopathy (DR), which can develop into a more serious condition which is diabetic macular edema (DME).”

https://www.bayer.com/media/en-us/new-data-from-pivotal-studies-with-aflibercept-8-mg/#

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