Aflibercept 8 mg shows efficacy for patients with diabetic macular edema regardless of sex, age, and race/ethnicity.
Aflibercept 8 mg improved best-corrected visual acuity (BCVA) among patients with diabetic macular edema, according to findings presented at the 2023 annual meeting of the American Academy of Ophthalmology (AAO).
Sean Adrean, MD, presented results of the PHOTON trial, an ongoing, 96-week noninferiority trial that examines the efficacy and safety of aflibercept 8 mg every 12 or 16 weeks following three monthly doses (8 mg every 12 weeks [8q12]: n=328; 8 mg every 16 weeks [8q16]: n=163) versus aflibercept 2 mg given every 8 weeks after five monthly doses (2 mg every 8 weeks [2q8]: n=167). The researchers assessed the mean change from baseline in BCVA at week 48 with aflibercept 8 mg versus 2 mg based on sex, age, race, and ethnicity
Aflibercept 8 Mg Effective Regardless of Sex, Age, and Race/Ethnicity
The mean BCVA change from baseline (measured in letter scores) at week 48, based on sex, was +8.7 with aflibercept 2q8, +8.4 with 8q12, and +8.3 in 8q16 among men (n=401) and +9.8 with aflibercept 2q8, +9.6 with 8q12, and +7.2 with 8q16 among women (n=257).
The mean BCVA change from baseline by age was +13.0 with aflibercept 2q8, +10.2 with 8q12, and +11.1 with 8q16 among those aged less than 55 (n=144); +10.3 with 2q8, +8.0 with 8q12, and +7.1 with 8q16 among those aged 55 and older to younger than 65 (n=225); and +6.9 with aflibercept 2q8, +9.2 with 8q12, and +7.0 with 8q16 among those aged 65 and older to younger than 75 (n=218).
Dr. Adrean reported that results were comparable by race (White patients, n=471; Asian patients, n=101) and ethnicity (Hispanic or Latino patients, n=119; non-Hispanic or Latino, n=525). The investigators were unable to evaluate certain subgroups, including patients aged 75 and older and Black patients, due to a small sample size.
Benefits Extend Beyond Diabetic Macular Edema
The study results show that aflibercept 8 mg “achieved meaningful BCVA gains across evaluable subgroups,” according to the researchers.
The findings related to aflibercept 8 mg for diabetic macular edema presented at AAO follow positive results seen for aflibercept 8 mg versus 2 mg in treatment-naïve neovascular age-related macular degeneration (nAMD). The results for nAMD, which were presented at the American Society of Retina Specialists 2023 Annual Meeting, also showed aflibercept 8 mg providing improvements for BCVA.