Bayer submitted an application to the European Medicines Agency (EMA) to expand treatment intervals of up to 6 months with Eylea™ 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME)
Submission is based on positive three-year results from the open-label extension studies of the clinical trials PULSAR (in nAMD) and PHOTON (in DME)
28% of patients in DME and 24% of patient in nAMD had a last assigned treatment interval of 6 months at the end of three years
BERLIN, Germany I February 10, 2025 I Bayer has submitted an application to the European Medicines Agency (EMA) to expand treatment intervals of up to 6 months with Eylea™ 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).
The submission is based on positive three-year results from open-label extension studies of the clinical trials PULSAR, in nAMD and PHOTON, in DME. In both extension studies patients randomized to Eylea 8 mg from baseline maintained their visual and anatomic improvements, with 28% of patients in DME and 24% of patients in nAMD having a last assigned dosing interval of 6 months at the end of three years.
“Longer dosing intervals address a critical unmet medical need and offer patients living with retinal diseases greater flexibility and a reduced burden from frequent injections and hospital visits. This is also important to those that care for these patients,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceuticals Leadership Team at Bayer. “Eylea 8 mg was the first anti-VEGF to receive a 5-month label in the EU, and the new data support a substantial proportion of patients have the potential to maintain 6-month extended treatment intervals.”
The safety profile of Eylea 8 mg continued to be favorable in the third year in both studies and is consistent with the well-established safety profile of Eylea 2 mg. The long-term safety data did not show any new signals in both trials, including patients switching from Eylea 2 mg to Eylea 8 mg. The rates for ocular treatment emergent adverse events were similar in all treatment groups.
Eylea™ 8 mg (aflibercept 8 mg) has been approved to date in more than 50 markets for the treatment of nAMD and DME. Further regulatory applications for Eylea 8 mg in additional markets are ongoing.
Eylea is a global market leader for the treatment of retinal eye diseases with anti-vascular endothelial growth factors (anti-VEGF), with more than 85 million applications and more than 12 million patient-years of experience worldwide.
Eylea 8 mg (aflibercept 8 mg; in the United States: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD 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 2 mg and Eylea 8 mg.
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 a few 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. 170 million people worldwide are living with AMD – it is anticipated that this figure will increase to 288 million by 2040. Approximately 10% of people with AMD will develop the advanced form nAMD.
Diabetic macular edema (DME) is a common complication in eyes of people living with diabetes. DME occurs when high levels of blood sugar leads 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 affects around 27 million people globally.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.
Find more information at https://pharma.bayer.com
Follow us on Facebook: http://www.facebook.com/bayer
SOURCE: Bayer
Post Views: 191
Bayer submitted an application to the European Medicines Agency (EMA) to expand treatment intervals of up to 6 months with Eylea™ 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME)
Submission is based on positive three-year results from the open-label extension studies of the clinical trials PULSAR (in nAMD) and PHOTON (in DME)
28% of patients in DME and 24% of patient in nAMD had a last assigned treatment interval of 6 months at the end of three years
BERLIN, Germany I February 10, 2025 I Bayer has submitted an application to the European Medicines Agency (EMA) to expand treatment intervals of up to 6 months with Eylea™ 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).
The submission is based on positive three-year results from open-label extension studies of the clinical trials PULSAR, in nAMD and PHOTON, in DME. In both extension studies patients randomized to Eylea 8 mg from baseline maintained their visual and anatomic improvements, with 28% of patients in DME and 24% of patients in nAMD having a last assigned dosing interval of 6 months at the end of three years.
“Longer dosing intervals address a critical unmet medical need and offer patients living with retinal diseases greater flexibility and a reduced burden from frequent injections and hospital visits. This is also important to those that care for these patients,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceuticals Leadership Team at Bayer. “Eylea 8 mg was the first anti-VEGF to receive a 5-month label in the EU, and the new data support a substantial proportion of patients have the potential to maintain 6-month extended treatment intervals.”
The safety profile of Eylea 8 mg continued to be favorable in the third year in both studies and is consistent with the well-established safety profile of Eylea 2 mg. The long-term safety data did not show any new signals in both trials, including patients switching from Eylea 2 mg to Eylea 8 mg. The rates for ocular treatment emergent adverse events were similar in all treatment groups.
Eylea™ 8 mg (aflibercept 8 mg) has been approved to date in more than 50 markets for the treatment of nAMD and DME. Further regulatory applications for Eylea 8 mg in additional markets are ongoing.
Eylea is a global market leader for the treatment of retinal eye diseases with anti-vascular endothelial growth factors (anti-VEGF), with more than 85 million applications and more than 12 million patient-years of experience worldwide.
Eylea 8 mg (aflibercept 8 mg; in the United States: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD 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 2 mg and Eylea 8 mg.
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 a few 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. 170 million people worldwide are living with AMD – it is anticipated that this figure will increase to 288 million by 2040. Approximately 10% of people with AMD will develop the advanced form nAMD.
Diabetic macular edema (DME) is a common complication in eyes of people living with diabetes. DME occurs when high levels of blood sugar leads 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 affects around 27 million people globally.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.
Find more information at https://pharma.bayer.com
Follow us on Facebook: http://www.facebook.com/bayer
SOURCE: Bayer
Post Views: 191
