Maculopathy and diabetic edema, studies confirm aflibercept efficacy

Neovascular age-related macular degeneration (nAMD) is a rapidly progressive eye disease that, if left untreated, can lead to vision loss within months. Worldwide, 170 million people have age-related macular degeneration (AMD), a figure expected to rise to 288 million by 2040. Approximately 10% of people with AMD will develop the advanced neovascular form. Diabetic macular edema (DME) is an eye complication in people with diabetes that can lead to vision loss and, in some cases, blindness. Currently, 146 million people globally have diabetic retinopathy (DR), which can progress to the more serious condition, DME, which affects approximately 27 million people worldwide. Good news for these patients comes from the Annual Meeting of the European Society of Retinal Specialists (Euretina2024), scheduled from 19 to 22 September in Barcelona: further evidence from the Pulsar and Photon studies confirms the long-lasting efficacy and safety data of intravitreal aflibercept 8 mg, with long treatment intervals, in different patient populations affected by nAMD and DME.

Bayer announced this at Euretina2024 with 3 symposia and 8 abstracts to discuss the results of the registration studies in clinical practice in nAmd and Dme, highlighting the benefits for patients treated with aflibercept 8 mg. Aflibercept 8 mg – the note reports – was developed to reduce the burden of disease management and extend the treatment intervals between administrations, with efficacy and safety comparable to those of the standard of care aflibercept 2 mg. The success of the registration clinical studies Pulsar and Photon led to the approval of the drug in the EU for nAmd and Dme, with the possibility for the first time to extend the treatment intervals up to 5 months. Furthermore, the initial loading phase provides, again for the first time, only 3 monthly injections for both patients affected by nAmd and patients with Dme with further reduction of the burden.

“Many of our patients require a long-term approach to control their retinal disease and preserve their vision. This is exactly what the clinical trials with aflibercept 8 mg have shown, and it represents a turning point in the care of retinal diseases,” said Anat Loewenstein, MD, Director of the Department of Ophthalmology at Tel Aviv Medical Center.

In recent days – the note reads – aflibercept 8 mg has also obtained a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval in the EU of the pre-filled syringe for the administration of aflibercept 8 mg (114.3 mg/ml solution for injection). The new device (OcuClickTM) will offer ophthalmologists a simple and effective way to precisely administer the 70 μl dose of aflibercept 8 mg in the approved indications. This simple, easy-to-use and accurate system will bring significant benefits to patients and ophthalmologists, with the certainty of quickly and precisely administering the correct dosage of aflibercept 8 mg.

Aflibercept 8 mg was developed by Bayer together with Regeneron, which has exclusive rights to aflibercept 2 mg and aflibercep 8 mg in the United States. Bayer has licensed exclusive marketing rights outside the United States. Aflibercept 8 mg (114.3 mg/ml solution for injection) has been approved in more than 40 countries to date for the treatment of neovascular age-related macular degeneration and diabetic macular edema. Applications for the use of aflibercept 8 mg are pending in other countries.