Among patients with diabetic macular edema (DME), reducing the treatment burden of frequent injections is a critical unmet need. For patients with DME, aflibercept 8 mg met the primary efficacy endpoint of the PHOTON study, according to Diana V. Do, MD. “This demonstrates non-inferiority in best-corrected visual acuity versus aflibercept 2 mg, with no new safety signals through 48 weeks,” Dr. Do wrote, adding that these vision benefits lasted through 2 years of treatment.
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 (89% in [the group receiving 8 mg every 16 weeks]),” she wrote. Overall, compared with aflibercept 2 mg, aflibercept 8 mg provides an expanded injection interval, greater therapeutic benefit, and equivalent safety, according to the study team.
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.
