Bayer and Regeneron presented the three-year results from the open-label extension of the PHOTON clinical trial on diabetic macular edema (DME) at the American Academy of Ophthalmology Annual Meeting, held October 18-21 in Chicago. The study showed that patients initially treated with Eylea 8 mg maintained significant visual and anatomical improvements over three years, with most achieving extended dosing intervals of at least three months. Notably, 45% of patients had a final dosing interval of five months or more, and 25% reached six months. The data also highlighted a slower rate of fluid reaccumulation in patients switched to Eylea 8 mg compared to Eylea 2 mg. The safety profile for Eylea 8 mg remained consistent and favorable in the third year.
“These long-term results are remarkable, demonstrating that Eylea 8 mg can provide sustained disease control with extended dosing for most patients in real-world conditions,” said Dr. Diana Do, Professor of Ophthalmology at Stanford University. “This data positions Eylea 8 mg as a potential new standard of care for DME.”
Christine Roth, Bayer’s Executive Vice President for Global Product Strategy, emphasized that Eylea 8 mg addresses a critical need for longer treatment intervals, reducing the burden on patients and easing demands on eye care clinics.
The trial confirmed that the efficacy, measured by the mean change in best-corrected visual acuity (BCVA), was sustained across all groups throughout the third year. The safety data remained in line with Eylea 2 mg’s established profile, with no new safety concerns and similar rates of ocular adverse events among all groups. Intraocular inflammation rates were low (1.4% for Eylea 8 mg switch patients, 1.5% for those on Eylea 2 mg), and no cases of occlusive vasculitis were reported.
The PHOTON results affirm the durable efficacy and safety of Eylea 8 mg, offering patients and physicians a way to reduce the treatment burden without compromising on outcomes compared to the current standard of Eylea 2 mg.
Eylea 8 mg is the only anti-VEGF therapy approved for dosing intervals of up to five months in DME and nAMD in major markets like the EU, UK, and Japan. It is co-developed by Bayer and Regeneron, with the latter holding exclusive U.S. rights, while Bayer markets the drug outside the U.S., sharing profits from Eylea sales.
