Bayer and its collaboration partner Regeneron presented results from the open-label extension study of the clinical trial PHOTON in patients with diabetic macular edema (DME) at three years, in a late-breaking session at the American Academy of Ophthalmology Annual Meeting, 18-21 October, Chicago, USA. Patients randomized to Eylea 8 mg from baseline maintained their visual and anatomic improvements at the end of three years, with the vast majority of patients on extended dosing intervals of ≥ 3 months. 45% of patients had a last completed dosing interval of ≥ 5 months, and 25% completed a last dosing interval of 6 months at the end of three years. Notably, patients switched to Eylea 8 mg demonstrated substantially slower fluid reaccumulation after their first Eylea 8 mg dose, as compared to their previous rate of fluid reaccumulation with Eylea 2 mg. The safety profile of Eylea 8 mg continued to be favorable in the third year.
“These long-term results are unprecedented and demonstrate that Eylea 8 mg successfully achieves sustained disease control with extended treatment intervals for the vast majority of patients in a setting similar to real-world clinical practice,” said Diana Do, MD, Professor of Ophthalmology and Vice Chair for Clinical Affairs at the Byers Eye Institute, Stanford University, USA. “Based on the positive data Eylea 8 mg has the potential to become the new standard of care therapy in diabetic macular edema.”
“Eylea 8 mg, truly addresses a significant unmet need to extend the treatment interval for patients with diabetic macular edema,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceuticals Leadership Team at Bayer. “This will help reduce the burden of disease on patients, improve treatment adherence, and alleviate capacity constraints in eye care clinics.”
Eylea 8 mg has the potential to extend treatment intervals for all DME-patients. Efficacy evaluated by mean change in best-corrected visual acuity (BCVA) was maintained in all Eylea 8 mg patient groups throughout the third year (week 156) compared to the start of the extension study (baseline at week 96).
The safety profile of Eylea 8 mg continued to be favorable in the third year and is consistent with the well-established safety profile of Eylea 2 mg. The long-term safety data did not show any new signals for any of the treatment groups 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. No cases of occlusive vasculitis were reported. The rate for intraocular inflammation was low throughout the three years (1.4% in patients switched to Eylea 8 mg, and 1.5% in patients randomized at baseline to Eylea 2 mg).
These long-term data from PHOTON show the continued durable efficacy and safety of Eylea 8 mg. For patients and ophthalmologists this means reduced burden of disease with comparable efficacy and safety to the current standard of care Eylea 2 mg.
Eylea 8 mg is the only anti-VEGF treatment that is approved for treatment intervals of up to 5 months in DME and nAMD in major markets like the EU, UK, and Japan.
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 following any regulatory approvals.
