Among patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (AMD), reducing the treatment burden of frequent injections of VEGF inhibitors is a critical unmet need. Recently, the FDA approved aflibercept 8 mg for the treatment of DME, diabetic retinopathy, and neovascular age-related macular degeneration based on positive phase 3 clinical trial results. In DME, aflibercept 8mg met the primary efficacy endpoint in the PHOTON study, according to Diana V. Do, MD. “This global clinical trial demonstrated that aflibercept 8mg was non-inferior to aflibercept 2mg in mean best-corrected visual acuity at 48 weeks,” Dr. Do wrote, adding that these vision benefits lasted through 2 years of treatment with an excellent safety profile.
Dr. Do and colleagues sought to determine whether aflibercept 8 mg showed comparable efficacy and safety to aflibercept 2 mg in patients with DME. She presented their findings at the American Society of Retina Specialists 2023 Annual Scientific Meeting, held recently in Seattle.
“The majority of patients maintained extended dosing (≥12 weeks; 93% in [groups receiving 8 mg combined]) and 16-week dosing intervals (89% in [the group receiving 8 mg every 16 weeks]),” she wrote. Overall, compared with aflibercept 2 mg, aflibercept 8 mg provides similar visual acuity gains and reductions in retinal thickness. The benefit of aflibercept 8mg is the expanded injection interval resulting in fewer office visits and injections for patients.
Dosing Intervals Were Maintained or Extended for 2 Years
These findings were based on the PHOTON study, a phase 3 clinical trial that compared aflibercept 8 mg with aflibercept 2 mg in patients with DME. Patients with DME were randomly assigned to receive aflibercept 8 mg every 12 weeks (n=328) or 16 weeks (n=163) after three monthly doses, or aflibercept 2 mg every 8 weeks after five monthly doses (n=167).
Dr. Do and colleagues observed that the vast majority of patients taking aflibercept 8 mg were able to maintain, or further extend, these dosing intervals throughout 2 years. They observed that:
- 89% maintained 12 or more week–dosing through 2 years, compared with 93% through 1 year (48 weeks);
- 83% maintained 16 or more week–dosing through 2 years, compared with 89% maintaining 16-week dosing through 1 year; and
- 43% met the criteria for 20 or more week–dosing by week 96, including 16% and 27% who were eligible for 20- and 14-week dosing intervals, respectively.
“Reducing the treatment burden of frequent injections in patients with DME is a critical unmet need, and the 2-year PHOTON results demonstrated the potential of aflibercept 8 mg to positively impact the vision and lives of patients with DME,” Dr. Do says. “With the recent FDA approval, aflibercept 8mg will provide retina specialists with a new treatment option to offer their patients.”