Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Technical Presentation (February 2026)
19 slides from Regeneron Pharmaceuticals's technical presentation, Feb 7, 2026
Slide 1: Safety and Efficacy of Aflibercept 8 mg in Patients with nAMD or DME: Primary Results from ELARA
Safety and Efficacy of Aflibercept 8 mg in Patients with nAMD or DME: Primary Results from the Phase 3b ELARA Trial David M. Brown, MD,1 on behalf of the ELARA study investigators 1Retina Consultants of Texas, Retina Consultants of America, Houston, TX, USA Presented at Angiogenesis, Exudation, and
Slide 2: Disclosures
Disclosures • David Brown has served as scientific advisor for Regeneron/Bayer and Genentech/Roche and as a member of the Regeneron Combination Products Steering Committee • The ELARA trial was sponsored by Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA). The sponsor participated in the design
Slide 3: Background
Background • Aflibercept 8 mg at extended dosing intervals demonstrated BCVA gains and CRT reductions comparable to aflibercept 2q8 over 2 years in pivotal trials in nAMD (PULSAR) and DME (PHOTON)1-4 – In both trials, the majority of aflibercept 8 mg-treated patients achieved ≥16-week dosing interva
Slide 4: ELARA Study Design
ELARA Study Design 1110 patients enrolled across 53 US sites Study eyes (N=1110) previously treated with ≥3 anti-VEGF injections within T&E regimen per DRM criteriaa,b 5 months prior to study start in: nAMD (n=622) DME (n=488) 0 4 8 12 16 20 24 96 Patients aged Patients aged EOS ≥50 years with CNV ≥
Slide 5: Patient Disposition at Week 24
Patient Disposition at Week 24 nAMD DME Total Enrolled 622 488 1110 Completed Week 24, n (%) 595 (95.7) 471 (96.5) 1066 (96.0) Reason for discontinuation, n Withdrawal of consent 20 10 30 Adverse event 4 3 7 Death 2 2 4 Lost to follow-up 1 2 3 SAF. SAF, safety analysis set. 6
Slide 6: Baseline Demographics
Baseline Demographics nAMD DME Total (n=622) (n=488) (N=1110) Age, mean (SD), years 77.1 (8.5) 62.8 (9.8) 70.8 (11.5) Female, n (%) 360 (57.9) 203 (41.6) 563 (50.7) Hispanic or Latino, n (%) 43 (6.9) 114 (23.4) 157 (14.1) Race, n (%) White 589 (94.7) 387 (79.3) 976 (87.9) Black or African American 8
Slide 7: Baseline Characteristics of Study Eye
Baseline Characteristics of Study Eye nAMD DME Total (n=622) (n=488) (N=1110) BCVA, mean (SD), 68.0 (15.3) 69.8 (13.4) 68.8 (14.5) ETDRS letters Snellen equivalent 20/40 20/40 20/40 Patients with BCVA >73 276 (44.4) 232 (47.5) 508 (45.8) ETDRS letters, n (%) CST, mean (SD), µm 254.3 (66.0) 328.1 (10
Slide 8: Previous Anti-VEGF Treatment Within Prior 6 Months
Previous Anti-VEGF Treatment Within Prior 6 Months Proportion of patients, % Only nAMD DMEa Total (n=622) (n=488) (N=1110) SAF. aData for 1 patient in the DME cohort were missing. bRanibizumab or ranibizumab biosimilar (ranibizumab-eqrn or ranibizumab-nuna). 9
Slide 9: Number of Previous Anti-VEGF Injections in Study Eye
Number of Previous Anti-VEGF Injections in Study Eye 6 Months Prior to Study Start nAMD DMEa Total (n=622) (n=488) (N=1110) Previous anti-VEGF injections in the study eye in prior 6 months, n (%) 3 injections 181 (29.1) 195 (40.0) 376 (33.9) 4 injections 212 (34.1) 175 (35.9) 387 (34.9) 5 injections
Slide 10: Mean Change in BCVA in Patients with nAMD
Mean Change in BCVA Through Week 24 in Patients with nAMD Mean change in BCVA, ETDRS letters +2.5 letters Week Proportion of Mean number Mean BCVA Mean change in patients with of injections at BL BCVA at Week 24 ≥5-letter gain through Week 24 at Week 24 nAMD (n=622) 68.0 letters +2.5 letters 32.9% 6
Slide 11: Mean Change in CST in Patients with nAMD
Mean Change in CST Through Week 24 in Patients with nAMD Week Mean change -27.1 µm in CST, µm Mean number Mean CST Mean change in of injections at BL CST at Week 24 through Week 24 nAMD (n=622) 254.3 µm -27.1 µm 6.0 SAF, observed cases.
Slide 12: Mean Change in BCVA in Patients with DME
Mean Change in BCVA Through Week 24 in Patients with DME Mean change in BCVA, ETDRS letters +3.2 letters Week Proportion of Mean number Mean BCVA Mean change in patients with of injections at BL BCVA at Week 24 ≥5-letter gain through Week 24 at Week 24 DME (n=488) 69.8 letters +3.2 letters 36.8% 5.8
Slide 13: Mean Change in CST in Patients with DME
Mean Change in CST Through Week 24 in Patients with DME Week Mean change in CST, µm -39.7 µm Mean number Mean CST Mean change in of injections at BL CST at Week 24 through Week 24 DME (n=488) 328.1 µm -39.7 µm 5.8 SAF, observed cases.
Slide 14: Ocular Safety in the Study Eye Through Week 24
Ocular Safety in the Study Eye Through Week 24 nAMD DME Total (n=622) (n=488) (N=1110) Patients with ≥1 ocular TEAE, n (%) 106 (17.0) 109 (22.3) 215 (19.4) Ocular TEAEs occurring in >15 patients overall, n (%) Conjunctival hemorrhage 21 (3.4) 18 (3.7) 39 (3.5) Cataract 7 (1.1) 13 (2.7) 20 (1.8) Vitr
Slide 15: Intraocular Inflammation in the Study Eye Through Week 24
Intraocular Inflammation in the Study Eye Through Week 24 nAMD DME Total (n=622) (n=488) (N=1110) Patients with ≥1 IOI TEAE, n (%) 6 (1.0) 5 (1.0) 11 (1.0) Endophthalmitis 1 (0.2) 3 (0.6) 4 (0.4) Eye inflammation 2 (0.3) 0 2 (0.2) Iritis 1 (0.2) 1 (0.2) 2 (0.2) Eye infection 1 (0.2) 0 1 (<0.1) Irido
Slide 16: Intraocular Pressure in the Study Eye Through Week 24
Intraocular Pressure in the Study Eye Through Week 24 nAMD DME Total (n=622) (n=488) (N=1110) Patients with ≥10 mmHg increase 16/616 (2.6%) 15/486 (3.1%) 31/1102 (2.8%) in pre-dose IOP from baselinea Patients with pre-dose IOP 10/622 (1.6%) 13/488 (2.7%) 23/1110 (2.1%) ≥25 mmHga Patients with pre- o
Slide 17: Mean Change in Pre-dose IOP in All Patients
Mean Change in Pre-dose IOP in IOP, mmHg in All Patients Through Week 24 Mean change -0.2 mmHg Week SAF.
Slide 18: Non-ocular Safety Through Week 24
Non-ocular Safety Through Week 24 nAMD DME Total (n=622) (n=488) (N=1110) Patients with ≥1 serious non-ocular 31 (5.0) 35 (7.2) 66 (5.9) TEAE, n (%) Serious non-ocular TEAEs occurring in ≥3 patients overall, n (%) Cerebrovascular accident 1 (0.2) 3 (0.6) 4 (0.4) Myocardial infarction 2 (0.3) 2 (0.4)
Slide 19: ELARA Summary of Week 24 Results
ELARA Summary of Week 24 Results • Aflibercept 8 mg every 4 weeks achieved meaningful functional and anatomic improvements at Week 24 in patients previously treated with anti-VEGF agents for nAMD or DME • The safety profile of monthly dosing with aflibercept 8 mg through Week 24 was consistent with
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