Slide 1: Aflibercept 8 mg for DME: 96-Week Results From the Phase 2/3 PHOTON Trial
Aflibercept 8 mg for Diabetic Macular Edema: 96-Week Results From the Phase 2/3 PHOTON Trial Charles C. Wykoff,1 on behalf of the PHOTON study investigators 1Retina Consultants of Texas, Retina Consultants of America Blanton Eye Institute, Houston, TX, USA Presented at EURETINA 2023 Meeting, October
Slide 2: Disclosures
Disclosures DME • Charles C. Wykoff: 4DMT (C, R), Abbvie (C), Adverum (C, R), Aerie (C), AffaMed (R), AGTC (C), Alcon (C), Alexion (R), Alimera (R), Annexin (R), Annexon (C, R), Apellis (C, R), Ascidian (C), Asclepix (R), Bausch + Lomb (C), Bayer (C, R), Boehringer Ingelheim (C, R), Clearside (C, R)
Slide 3: PHOTON Study Design
PHOTON Study Design Multi-center, randomized, double-masked study in adult patients with center-involved DME® Randomized 1 (2q8) : 2 (8q12) : 1 (8q16) Note: 2 mg arm received 5 initial monthly injections versus 8 mg arms, which received only 3 initial monthly injections 2q8 Aflibercept 2 mg every 8
Slide 4: PHOTON: Dosing Schedule and Dose Regimen Modification
PHOTON: Dosing Schedule and Dose Regimen Modification DME
Slide 5: Patient Disposition and Baseline Characteristics
Patient Disposition and Baseline Characteristics DME
Slide 6: Baseline DRSS Level of the Study Eye
Baseline DRSS Level of the Study Eye DME
Slide 7: Mean Change in BCVA at Week 96
Mean Change in BCVA at Week 96 DME
Slide 8: Mean Change in BCVA at Week 96
Mean Change in BCVA at Week 96 DME
Slide 9: Large Majority of Aflibercept 8 mg Patients Maintained Randomized Intervals Through Week 96
Large Majority of Aflibercept 8 mg Patients Maintained Randomized Intervals Through Week 96 DME
Slide 10: Last Assigned Dosing Interval at Week 96
Last Assigned Dosing Interval at Week 96 DME
Slide 11: Proportion of Patients With ≥2-step DRSS Improvement at Weeks 12, 48, and 96
Proportion of Patients With ≥2-step DRSS Improvement at Weeks 12, 48, and 96 DME
Slide 12: Mean Change in Central Retinal Thickness
Mean Change in Central Retinal Thickness DME LS mean values (censoring data post-ICE); FAS: 2q8 n=167; 8q12 n=328; 8q16 n=163 (at baseline). LS mean values were generated using MMRM, with baseline CRT as a covariate, treatment group (aflibercept 2q8, 8q12, 8q16) and stratification variables (geograp
Slide 13: Safety Through Week 96
Safety Through Week 96 E> GP «> 167 328 163 N (SAF) Ocular safety Patients with 21 ocular AE (%)? Patients with 21 IOI AE (%)? Patients with IOP 235 mmHg pre- or post-injection (%)?° Non-ocular safety APTC events (%)? Hypertension events (%)? Non-ocular SAEs (%)? Deaths (%)° Ocular AEs occurring in
Slide 14: PHOTON: 96-week Results
PHOTON: 96-week Results • 8q12 and 8q16 groups had non-inferior BCVA compared to 2q8 at Week 96, with up to 6 fewer injections • Through Week 96, 89% of 8 mg patients maintained ≥12-week dosing intervals DME – At Week 96, 44% of 8 mg patients had a last assigned dosing interval of ≥20 weeks • Safety
Slide 15: Thank you to all co-investigators and patients who participated in the PHOTON trial
Thank you to all co-investigators and patients who participated in the PHOTON trial DME