Slide 1: Baseline Characteristics of Patients Who Did or Did Not Maintain 12- & 16-Week Aflibercept 8 mg Dosing Intervals
Baseline Characteristics of Patients Who Did or Did Not Maintain 12- & 16-Week Aflibercept 8 mg Dosing Intervals in the Phase 2/3 PHOTON Trial Diana V. Do,1 on behalf of the PHOTON study investigators 1Byers Eye Institute, Stanford University School of Medicine, Palo Alto, CA, USA Presented at the 5
Slide 2: Disclosures
Disclosures DME • Diana V. Do is a consultant to Boehringer Ingelheim, Genentech, Kodiak Sciences, Kriya, and Regeneron Pharmaceuticals, Inc.; has received research funding from Boehringer Ingelheim, Genentech, Kriya, and Regeneron Pharmaceuticals, Inc.; and has stock options from Kodiak Sciences •
Slide 3: PHOTON Study Design
PHOTON Study Design Multi-center, randomized, double-masked study in patients with 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 weeks after 5 initial
Slide 4: Dosing Schedule and DRM Criteria in Year 1
Dosing Schedule and DRM Criteria in Year 1 DME
Slide 5: Large Majority of 8 mg Patients Maintained Randomized Intervals Through Week 48
Large Majority of 8 mg Patients Maintained Randomized Intervals Through Week 48 DME
Slide 6: Objectives and Methods
Objectives and Methods Objectives: DME • To describe baseline characteristics of patients with maintained vs shortened dosing intervals • To identify baseline characteristics associated with shortened dosing intervals • To evaluate visual and anatomic outcomes at Week 48 in patients with maintained
Slide 7: Baseline Demographics by Dosing Interval
Baseline Demographics by Dosing Interval DME
Slide 8: Baseline Characteristics by Dosing Interval
Baseline Characteristics by Dosing Interval 8q12 (n=300)a 8q16 (n=156)a DME Maintained Shortened Maintained Shortened n (%) 273 (91.0) 27 (9.0) 139 (89.1) 17 (10.9) Type 2 diabetes (%) 94.5 92.6 95.0 94.1 Duration of diabetes (years) 15.5 (10.1) 11.1 (9.7) 15.6 (10.5) 15.8 (11.0) BMI (kg/m2) 30.3 (6
Slide 9: Univariable Analysis: Baseline Characteristics Associated With the Incidence of Dosing Interval Shortening
Univariable Analysis: Baseline Characteristics Associated With the Incidence of Dosing Interval Shortening DME
Slide 10: Multivariable Analysis: Baseline Characteristics Associated With the Incidence of Dosing Interval Shortening
Multivariable Analysis: Baseline Characteristics Associated With the Incidence of Dosing Interval Shortening DME
Slide 11: Absolute BCVA at Baseline and Week 48 by Dosing Interval
Absolute BCVA at Baseline and Week 48 by Dosing Interval DME
Slide 12: Absolute CRT at Baseline and Week 48 by Dosing Interval
Absolute CRT at Baseline and Week 48 by Dosing Interval DME
Slide 13: Conclusions
Conclusions DME • Aflibercept 8q12 and 8q16 demonstrated non-inferior BCVA gains compared to aflibercept 2q8 at Week 48, with a large majority of patients maintaining their randomized 12- or 16-week dosing intervals – Dosing intervals were shortened in approximately 10% of patients • Lower BCVA and
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 <a * Through Week 96, 89% of 8 mg patients maintained 212-week dosing intervals — At Week 96, 44% of 8 mg patients had a last assigned dosing interval of 220 weeks + Safety