On January 24, 2024, Bayer announced that the Center for Drug Evaluation of the National Medical Products Administration had accepted the application for Aflibercept 8mg.Used for treatmentNeovascularizationSex(Wet) Age-Related Macular Degeneration (nAMD)TheMarketing application. Chinese regulatory authorities are currently reviewing the study data.This application is based onPhase III of nAMDPULSARPositive Results of Clinical Trials:Compared with Eylea (aflibercept 2mg) fixed 8-week dosing, aflibercept 8 mg achieved the primary endpoint of non-inferiority in best-corrected visual acuity (BCVA) at week 48. Aflibercept 8 mg has demonstrated greater durability for the vast majority of patients, maintaining a dosing interval of 12 or 16 weeks.
Christian Rommel, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Global Research and Development, stated: "Retinal diseases are a significant health issue in China, and for patients with neovascular age-related macular degeneration, vision loss can severely impact their lives. It may lead to disability, making it difficult to perform simple tasks such as reading, writing, and dressing. Although effective treatments are available, these patients may struggle to adhere to long-term treatment. Extending the treatment interval can address this important patient need by reducing the number of injections and alleviating the burden on patients."
InPULSARIn the trial, compared with Eylea (Aflibercept 2mg) administered once a month for the first three months and then fixed every 8 weeks, Aflibercept 8mg showed equivalent visual improvement while extending the treatment interval to 12 weeks and 16 weeks. Aflibercept 8mg demonstrated unprecedented drug durability. In the Aflibercept 8mg every 16-week dosing group, 77% of nAMD patients were able to maintain a 16-week dosing interval, with an average of 5 injections at 48 weeks; in the Aflibercept 8mg every 12-week dosing group, 79% of nAMD patients maintained a 12-week dosing interval, with an average of 6 injections at 48 weeks. At 48 weeks, compared with Eylea (Aflibercept 2mg), Aflibercept 8mg also showedEffusionRapid and effective control.
AfliberceptThe safety of 8 mg andEylea, whose safety has been verified（Aflibercept 2mgSimilar, and withItPre-clinical trialsEyleaConsistent safety. The incidence of intraocular inflammation and increased intraocular pressure with 8mg of aflibercept is low, similar to Eylea (2mg aflibercept). By week 48During the week, no cases of endophthalmitis or retinal vasculitis were observed, and no new safety signals were detected.
Eylea HD (Aflibercept 8 mg) was approved for marketing by the US FDA in August 2023. Currently, Eylea 8 mg (Aflibercept 8 mg, 114.3 mg/ml injection) has been approved in markets such as the EU and Japan for the treatment of nAMD and DME. Bayer has submitted registration applications for Aflibercept 8 mg in other markets.。
Bayer and Regeneron are jointly developing Aflibercept 8 mg. Regeneron has exclusive rights to Eylea (Aflibercept 2 mg) and Eylea HD in the United States. Bayer has obtained exclusive marketing rights outside the United States, and the two companies equally share the sales profits of Eylea and Eylea 8 mg.
About PULSAR
PULSARIt is double-blind、Positive ControlThe KeySexIIIPhase trial, conducted at multiple centers worldwide. PULSAREvaluationAfter completing the monthly treatment during the loading period,Aflibercept8 mg 12-Week and 16-Week Dosing RegimensCompared with Eylea®(Aflibercept 2 mg) Every 8-week dosing regimenEfficacy and Safety, with the primary endpoint at Week 48TimeBest Corrected Visual Acuity (BCVA) Non-Inferiority。PatientAt baselineRandomly assigned to three different groups. InPULSARIn the study, 1009NameThe patient received treatment.. AfliberceptAll patients in the 8 mg group started from Week 16,According toStrict, Clinically Relevant, Patient-Centered Dosing RegimenAdjustmentUnder the (DRM) standard, conduct continuous assessment.Patients in the aflibercept 8mg group received DRM standard assessments at multiple time points, and the dosing interval might be shortened to 8 or 12 weeks to ensure effective disease control until week 48.
About nAMD
Neovascular (Wet) Age-Related Macular Degeneration (nAMD) is a rapidly progressing eye disease that can lead to vision loss in as short as three months if left untreated. nAMD is one of the leading causes of irreversible blindness and visual impairment worldwide. nAMD is an age-related condition. When abnormal blood vessels grow and cause fluid leakage beneath the macula, it affects the macular region responsible for sharp central and fine vision. The leaking fluid damages the structure of the macula and eventually leads to macular scarring, resulting in vision loss. Globally, 196 million people are affected by AMD, and this number is expected to rise to 288 million by 2040.
