FDA Greenlights New Eylea Formulation for Wet AMD, DME, and DR
The US Food and Drug Administration (FDA) has granted clearance for the new 8 mg formulation of Eylea (aflibercept), marking a significant milestone in the treatment of various eye conditions. This approval applies to patients suffering from wet age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR). This achievement comes after the drug was initially rejected in June due to safety and quality control issues at its contract manufacturer, Catalent.
The concerns that led to the rejection of Eylea have been successfully addressed, paving the way for the new formulation’s approval. Additionally, this development has also led to the approval of Regeneron’s rare disease drug Veopoz. The new Eylea formulation offers an innovative solution to patients by providing a high-dose version of the VEGF inhibitor. This innovation results in a reduction in the frequency of required doses of the drug, which is administered through eye injections, without introducing any new safety concerns.
Clinical trials, notably the pivotal PULSAR and PHOTON trials, demonstrated the efficacy of the high-dose Eylea formulation. These trials showed that the new 8 mg formulation, with dosing intervals of either 12 or 16 weeks, is just as effective as the original 2 mg Eylea formulation, which necessitates injections every eight weeks. This effectiveness was observed in both AMD and DME cases. The treatment protocol typically involves monthly doses for the first three months, followed by injections every eight to 16 weeks for AMD and eight to 12 weeks for DR. According to Bayer and Regeneron, most patients can be successfully maintained on the 12- to 16-week dosing schedule with the new formulation.
Recent updates from the PULSAR trial showed promising results, revealing that 88% of patients were able to extend their dosing intervals to at least 12-week periods. Of these, 71% met the criteria for even longer gaps in treatment – 47% were able to extend intervals to 20 weeks or more, and 28% reached intervals of 24 weeks.
Aside from its clinical benefits, the new Eylea formulation also holds strategic significance for Regeneron and Bayer. It enables them to address the growing competition from Roche’s bispecific VEGF and Ang-2 inhibitor, Vabysmo (faricimab), which has been gaining market share due to its remarkably infrequent dosing schedule, as infrequent as once every four months.
In terms of sales, Regeneron reported Eylea sales of $4.7 billion in the first half of the year, experiencing a 4% decline. Notably, $2.9 billion of these sales came from the US market. In contrast, Vabysmo’s sales surged over 500%, reaching over $1.2 billion in the same period, with nearly $900 million originating from the US.
With the approval of the new formulation, Eylea stands a chance to catch up with Vabysmo in terms of dosing convenience. However, Roche has recently submitted an application for the approval of a third indication – retinal vein occlusion (RVO). This move could lead to further competition with Eylea and potentially add to its sales momentum if approved. The approval of the new Eylea formulation not only addresses patient and physician convenience but also positions the drug to compete effectively in the dynamic landscape of ophthalmic pharmaceuticals.
