Industry News
TGA Approves Eylea 8mg for nAMD and DME Treatment
The Australian Therapeutic Goods Administration (TGA) has granted approval for Eylea 8mg, a higher dosage of aflibercept, for the treatment of adults with neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DME). The approval, finalised on June 14, 2024, follows similar endorsements in the United States and Europe in late 2023.
Eylea 8mg's approval is underpinned by the pivotal PULSAR and PHOTON studies, which were double-masked, active-controlled trials that compared the new 8mg dose to the existing Eylea 2mg injection. Both trials demonstrated that Eylea 8mg achieved non-inferior and clinically equivalent vision gains at 48 weeks with 12- and 16-week dosing regimens, after an initial three monthly doses, compared to the more frequent eight-week dosing regimen of Eylea 2mg.
In the PULSAR trial, involving 1,009 nAMD patients, and the PHOTON trial, with 658 DME patients, the majority of those assigned to the 12- or 16-week Eylea 8mg dosing regimens maintained these intervals through the 48 weeks. The success of these trials highlights the potential for Eylea 8mg to reduce the treatment burden associated with frequent intravitreal injections significantly.
Adverse reactions reported in at least 3% of patients included cataract, conjunctival hemorrhage, increased intraocular pressure, ocular discomfort, blurred vision, vitreous floaters, vitreous detachment, corneal epithelium defect, and retinal hemorrhage.
Introducing a higher aflibercept dose aims to alleviate the frequent injection schedule, enhancing patient compliance and outcomes. For detailed dosing information for Eylea 8mg in Australia, healthcare professionals should refer to the TGA product information.
Eylea 8mg results from a collaborative development effort between Bayer and Regeneron. While Regeneron holds exclusive rights to the product in the U.S., Bayer has exclusive marketing rights outside the U.S., including Australia.