Sunir J. Garg, MD: Impact of Prior DME Treatment on Aflibercept 8 mg Outcomes

Subgroup analysis of the Phase 2/3 PHOTON trial revealed visual and anatomical improvements with aflibercept 8 mg treatment trended numerically higher in patients with diabetic macular edema (DME) without a history of prior treatment.

In an interview with HCPLive at the 128th Annual American Academy of Ophthalmology (AAO) Meeting., Sunir J. Garg, MD, Retina Service at Wills Eye Hospital, described the 96-week PHOTON data, highlighting the benefit of aflibercept 8 mg for all patients, but noting fewer visual acuity gains achieved for patients on 16-week dosing intervals.

“Our new treatments work really well, and they work well with less frequent dosing over time. That's a big deal for all of our patients, particularly for our diabetic patients, who tend to be younger working-age adults,” Garg told HCPLive. “Although it works well for both previously treated eyes as well as treatment-naive eyes, if you have patients who had previous treatment, they may benefit from slightly more frequent 8 mg dosing.”

Results from PHOTON showed non-inferior BCVA gains with aflibercept 8 mg with extended dosing intervals, compared with aflibercept 2 mg, in patients with DME, without new safety signals through Week 96. As approximately 44% of these patients had received prior treatment for DME, Garg and colleagues highlighted the opportunity to assess treatment outcomes by treatment history.

This subgroup analysis of PHOTON focused on visual and anatomic outcomes in patients by prior DME treatment status. PHOTON randomized adults with center-involved DME 1:2:1 to receive aflibercept 2 mg every 8 weeks (2q8) after 5 monthly injections, aflibercept 8 mg every 12 weeks (8q12) after 3 initial monthly injections, and aflibercept 8 mg every 16 weeks (8q16) after 3 initial monthly injections.

At Week 96, the mean BCVA change with 2q8 (n = 74), 8q12 (n = 146), and 8q16 (n = 71) was +7.3, +8.8, and +3.9 letters, respectively, in those with prior DME treatment. Among patients without DME treatment history, the changes were +9.5, +8.9, and +10.7, respectively.

Meanwhile, the mean change in CRT through Week 96 was –174 µm, –188 µm, and –146 µm in the 2q8, 8q12, and 8q16 groups, respectively, in those with prior DME treatment. For those without prior DME treatment, the mean CRT changes were –200, –182, and –163, respectively.

PHOTON data also showed the proportion of patients with ≥2-step Diabetic Retinopathy Severity Scale (DRSS) improvement was 23%, 25% and 17% in the prior treatment group and 38%, 41% and 26% in those without prior treatment, respectively.

Notably, similar proportions of patients with 8q12 and 8q16 groups achieved a least assigned dosing interval of ≥20 weeks at Week 96 in both those with prior DME treatment (42% and 44%, respectively) and those without prior DME treatment (44% and 49%, respectively).

“We know that patients, even when adjusted for the severity of the diabetic retinopathy, treatment-naive eyes had a better improvement than patients that were previously treated,” Garg told HCPLive. “And it's not just a ceiling effect. So there's a lot more that we're going to learn from this data set as time goes on.”

Disclosures: Relevant disclosures for Garg include Apellis, Boehringer Ingelheim, Genentech, Regeneron, and others.

Reference

_{Garg SJ. Outcomes with Aflibercept 8 mg and 2 mg by Prior DME Treatment Status: A Subgroup Analysis of the Phase 2/3 PHOTON Trial. Poster presented at the American Academy of Ophthalmology (AAO) 2024 Meeting. Chicago, Illinois. October 18-21, 2024.}