Bayer submits aflibercept 8 mg for regulatory approval in two major retinal eye diseases in the EU
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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 durability results with treatment intervals of up to 16 weeks, with comparable visual acuity as well as rapid and resilient fluid control to the comparator EyleaTM (aflibercept 2 mg) through to week 48 / Safety of aflibercept 8 mg was consistent with the safety profile of Eylea (aflibercept 2 mg) / Extended treatment intervals with less injections into the eye in nAMD and DME meet an important patient need
Berlin, February 6, 2023 – Bayer has submitted an application for market authorization to the European Medicines Agency (EMA) for aflibercept 8 mg in two major retinal eye diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).
The submission is based on positive data from the phase III study, PULSAR, in nAMD and the phase II/III study, PHOTON, in DME. At week 48, both studies met their primary endpoint of non-inferiority in terms of best corrected visual acuity (BCVA) of aflibercept 8 mg with two extended dosing regimens (every 12 and 16 weeks) compared to EyleaTM (aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses. 77% of nAMD and 89% of DME patients maintained 16-week dosing intervals with aflibercept 8 mg with an average of 5 injections through week 48. In the 12-week dosing groups, 79% of nAMD patients and 91% of DME patients maintained this dosing interval with aflibercept 8 mg with an average of 6 injections through week 48. In these studies, the safety profile of aflibercept 8 mg was consistent with the well-established safety profile of Eylea (aflibercept 2 mg).
“Patients with neovascular age-related macular degeneration and diabetic macular edema rely on continuous treatment to maintain their visual acuity and prevent visual impairment or even blindness – but some struggle with adherence. Therefore, extended treatment intervals meet an important patient need. The pivotal trials show unprecedented durability results of aflibercept 8 mg, while securing comparable visual acuity and a similar safety profile compared to Eylea, which is the gold standard,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer’s Pharmaceutical Division and Head of Research and Development.
Anatomic outcomes (secondary endpoints) were also investigated in the clinical trials: all aflibercept 8 mg arms demonstrated superior fluid control in nAMD and robust disease control with 12- and 16-week dosing in nAMD and DME versus Eylea (aflibercept 2 mg) through to week 48. Similar reductions in mean change of central retinal thickness (CRT) were achieved in nAMD and DME patients receiving aflibercept 8 mg with 12- and 16-week dosing versus Eylea (aflibercept 2 mg) with 8-week dosing at week 48.
The safety of aflibercept 8 mg in both trials was similar to the well-established safety profile of Eylea (aflibercept 2 mg) and consistent with previous clinical trials. The rates of intraocular inflammation (IOI) for aflibercept 8 mg compared to Eylea (aflibercept 2 mg) were 0.7% versus 0.6% in PULSAR and 0.8% versus 0.6% in PHOTON. No severe cases of IOI were observed. There were no clinically relevant differences in intraocular pressure between the treatment groups. In both trials, there were no cases of endophthalmitis, retinal vasculitis and no new safety signals through week 48.
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 to meet the important patient need of extended treatment intervals to reduce treatment burden. Aflibercept 8 mg will provide a 4-fold higher molar dose compared with the standard of care (aflibercept 2 mg) with an aim to increase Vascular Endothelial Growth Factor (VEGF) suppression time. 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 and PHOTON
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 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 both clinical trials patients on aflibercept 8 mg arms were assessed at multiple time points for DRM criteria to secure appropriate disease control through week 48.
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).
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