Bayer Ag · XETR:BAYN
Bayer — Technical Presentation (November 2023)
13 slides from Bayer's technical presentation, Nov 24, 2023
Slide 1: Aflibercept 8 mg for Diabetic Macular Edema: 60-Week Results From the Phase 2/3 PHOTON Trial
Aflibercept 8 mg for Diabetic Macular Edema: 60-Week Results From the Phase 2/3 PHOTON Trial Taiji Sakamoto,1 on behalf of the PHOTON study investigators 1Department of Ophthalmology, Kagoshima University Graduate School of Medical and Dental Science, Kagoshima, Japan Presented at the 62nd Annual Me
Slide 2: Disclosure of the Conflict of Interest
Disclosure of the Conflict of Interest DME First author: Taiji Sakamoto In relation to this presentation, I declare that there are no conflicts of interest • This study was sponsored by Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA) and co-funded by Bayer AG (Leverkusen, Germany). The sponsors
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 298 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: Mean Change in BCVA at Week 60
Mean Change in BCVA at Week 60 DME
Slide 7: Mean Change in BCVA at Week 60
Mean Change in BCVA at Week 60 DME
Slide 8: Large Majority of Aflibercept 8 mg Patients Maintained Randomized Intervals Through Week 60
Large Majority of Aflibercept 8 mg Patients Maintained Randomized Intervals Through Week 60 DME
Slide 9: Last Assigned Dosing Interval at Week 60
Last Assigned Dosing Interval at Week 60 DME Values may not add up to 100% due to rounding. aDosing intervals were extended in Year 2 if patients had <5-letter loss in BCVA from Week 12 AND CRT <300 µm (or <320 μm on Spectralis). bPatients completing Week 60. 10
Slide 10: Mean Change in Central Retinal Thickness at Week 60
Mean Change in Central Retinal Thickness at Week 60 DME
Slide 11: Safety Through Week 60
Safety Through Week 60 E> GP ce DME 167 328 163 491 N (SAF) Ocular safety in the study eye Patients with 21 ocular AE (%)? 35.4% Patients with 21 IOI AE (%)? 1.0% Patients with IOP 235 mmHg pre- or post-injection (%) 0.2% Non-ocular safety APTC events (%)? Hypertension events (%)? Non-ocular SAEs (%
Slide 12: PHOTON: 60-Week Results
PHOTON: 60-Week Results 8q12 and 8q16 groups achieved similar BCVA gains compared with 2q8 at Week 60 —— Through Week 60, 90% of 8q12 patients and 86% of 8q16 patients maintained 212- and 216-week dosing intervals, DME respectively — At Week 60, 43% of 8q12 patients and 82% of 8q16 patients had a la
Slide 13: 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