Bayer Ag · XETR:BAYN

Bayer — 38th Asia-Pacific Academy of Ophthalmology (APAO) Congress 2023

31 slides from Bayer's conference presentation, February 2023

  1. Slide 1: Intravitreal Aflibercept Injection 8mg for DME: 48-Week Results From the Phase 2/3 PHOTON Trial

    Intravitreal Aflibercept Injection 8mg for DME: 48-Week Results From the Phase 2/3 PHOTON Trial Taiji Sakamoto’ on behalf of the PHOTON study investigators ‘Kagoshima University, Kagoshima, Japan Presented at the 38 Asia-Pacific Academy of Ophthalmology (APAO) Congress, Kuala Lumpur, Malaysia, Febru

  2. Slide 2: Disclosures

    Disclosures * Taiji Sakamoto has received consulting fees from Bayer, Boehringer Ingelheim, Chugai/Roche, Novartis, and Senju *« The PHOTON study was sponsored by Regeneron Pharmaceuticals, Inc. (Tarrytown, NY) and co-funded by Bayer AG (Leverkusen, Germany). The sponsors participated in the design

  3. 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: 2mg arm received 5 initial monthly injections versus 8mg arms, which received only 3 initial monthly injections 2q8 Aflibercept 2mg every 8 weeks after 5 initial mon

  4. Slide 4: PHOTON: Dosing Schedule and Regimen Modification in Year 1

    PHOTON: Dosing Schedule and Regimen Modification in Year 1 DME Prima: Endpoit Wk 48 DRM Criteria for Shortening Dosing Interval* . . Intervals can only be + >10-letter loss in BCVA due to persistent or y Week 16 and 20: Patients on 8412 and worsening DME meeting DRM criteria shortened to Q8 AND Week

  5. Slide 5: Patient Disposition at Week 48

    Patient Disposition at Week 48 Ej @ & @D # Randomized # Discontinued before Week 48 Reasons for discontinuation Adverse event Investigator decision/ noncompliance? Consent withdrawal Lost to follow-up Death Categories were combined to maintain masking of individual patients.

  6. Slide 6: Baseline Characteristics of the Study Eye

    Baseline Characteristics of the Study Eye Ep @&@ & @D N (FAS/SAF) BCVA (ETDRS letters) 61.5 (11.2) 63.6 (10.1) 61.4 (11.8) 62.5 (10.9) Snellen equivalent 20/63 20/50 20/63 20/63 20/32 (>73 to 78 letters) 12.0% 18.0% 14.1% 15.5% 20/40 or worse (<73 letters) 88.0% 82.0% 85.9% 84.5% CRT (um) 457.2 (144

  7. Slide 7: PHOTON: 48-Week BCVA Primary Endpoint Met in Both 8mg Groups

    7) . oa = ® a a a fa) = WW PHOTON: 48-Week BCVA Primary Endpoint Met in Both 8mg Groups BCVA Change from Baseline +9.2 2q8 ~— +8.8 8q12 —<—[SS S—> +7.9 8q16 LS mean change from BL Diff. in LS means vs. 2q8 2-sided 95% Cl 1-sided test for non-inferiority at 4-letter margin at Week 48 (MMRM) 2q8 8.7 8

  8. Slide 8: Proportion of Patients With ≥2-step DRSS Improvement at Weeks 12 and 48

    Proportion of Patients With 22-step DRSS Improvement at Weeks 12 and 48 298 HB 8qi2 @ 8qié6 n 2 ra a g oO a - i) < 2 <4 r-) a ° 2 a Week 48 Key secondary endpoint *8q12 vs. 298 Diff (95% Cl): 1.98 (-6.61, 10.57) 48q16 vs. 298 Diff (95% Cl): -7.52 (-16.88, 1.84) F 9 LOGE (censoring data post-ICE); FA

  9. Slide 9: Proportion of 8mg Patients Maintaining Q12- and Q16-Week Intervals Through Week 48

    Proportion of 8mg Patients Maintaining a] Q12- and Q16-Week Intervals Through Week 48 4 Q16 2Q12 89% 93% DME 93% of 8mg patients maintained dosing intervals 212 weeks 8q12 (n=300)" 8q16 (n=156)* All 8mg (n=456)* nts shortened based on DRM assessments at some point through Week 48. nts completing Wee

  10. Slide 10: Mean Change in Central Retinal Thickness

    Mean Change in Central Retinal Thickness Note: 2mg arm received 5 initial monthly injections versus 8mg arms, which received only 3 initial monthly injections Despite fewer initial monthly doses, 8mg exhibited longer duration at each matched interval, thus achieving similar retinal thickness to 2mg

  11. Slide 11: Most Frequent Ocular AEs Through Week 48

    Most Frequent Ocular AEs Through Week 48 N (SAF) t 28 qt — 8q16 F All 8mg 167 328 163 491 Patients with 2 1 AE (%)* Cataract Conjunctival hemorrhage Intraocular pressure increased Punctate keratitis Retinal hemorrhage Vitreous floaters *Any ocular treatment-emergent AE in the study eye. AE, adverse

  12. Slide 12: Intraocular Inflammation Through Week 48

    Intraocular Inflammation Through Week 48 N (SAF) Patients with 2 1 IOIAE (%)* * No cases of endophthalmitis or occlusive retinal vasculitis Reported IOI terms: iridocyciitis, iritis, uveitis, vitreal cells, vitritis. *Treatment-emergent events. 101, intraocular inflammation.

  13. Slide 13: Intraocular Pressure Through Week 48

    Intraocular Pressure Through Week 48 N (SAF) Patients with lOP 2 35 mmHg pre- or post-injection (%) * Mean changes from baseline in pre-dose IOP did not exceed +1 mmHg at any timepoint through Week 48 IOP, intraocular pressure.

  14. Slide 14: Non-Ocular Safety Through Week 48

    Non-Ocular Safety Through Week 48 e> SP GP» a ™ N (SAF) Patients (%): APTC events* Hypertension events* Non-ocular SAEs* Deaths* “Treatment-emergent events; “All events. APTC, Anti-Platelet Trialists’ Collaboration; SAE, serious adverse events.

  15. Slide 15: PHOTON: 48-Week Results Primary Endpoint Met in Both 8mg Groups

    PHOTON: 48-Week Results Primary Endpoint Met in Both 8mg Groups * 8q12 and 8q16 groups had non-inferior BCVA compared to 2q8 at Week 48 * 8q12 met the non-inferiority margin of 15% in the proportion of patients with 22-step improvement in DRSS at Week 48 a BCVA Change from Baseline o ETDRS Letters o

  16. Slide 16: PHOTON: 48-Week Results Large Majority of 8mg Patients Maintained Randomized Intervals

    PHOTON: 48-Week Results Son Large Majority of 8mg Patients Maintained Randomized Intervals $ DME 93% of 8mg patients maintained dosing intervals 212 weeks Q16 2Q12 89% 93% 8q12 (n=300)* 8q16 (n=156)* All 8mg (n=456)* Patients shortened based on DRM assessments at some point through Week 48 ‘Patients

  17. Slide 17: Aflibercept 8mg in Patients with nAMD: 48-Week Results from the Phase 3 PULSAR Trial

    Aflibercept 8 mg in Patients with nAMD: 48-Week Results from the Phase 3 PULSAR Trial Andrew Chang,’ on behalf of the PULSAR study investigators 1Sydney Retina, Sydney, New South Wales, Australia Presented at the 38 Asia-Pacific Academy of Ophthalmology (APAO) Congress, Kuala Lumpur, Malaysia, Febru

  18. Slide 18: Disclosures

    Disclosures Andrew Chang has received consulting fees from Alcon, Allergan, Bayer, Novartis, and Roche The PULSAR study was sponsored by Bayer AG (Leverkusen, Germany) and co- funded by Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA). The sponsors participated in the design and conduct of the s

  19. Slide 19: PULSAR study design

    PULSAR study design Multicenter, randomized, double-masked study in patients with treatment-naive nAMD Randomized at baseline 1 (2q8) : 1 (8q12) : 1 (8q16) 2q8 Aflibercept 2 mg every 8 weeks after 3 initial monthly injections n=336 Primary endpoint at Week 48 Mean change in BCVA (non-inferiority) Ke

  20. Slide 20: PULSAR: Dosing Schedule and Regimen Modification in Year 1

    PULSAR: Dosing Schedule and Regimen Modification in Year 1 DRM Criteria for rtening Dosing Interval? DRM in Year 1 + >6-letter loss in BCVA due to persistent or Intervals can only be Week 16 and 20: Patients on 8912 and worsening nAMD 8q16 meeting DRM criteria shortened to q8 AND Week 24: Patients o

  21. Slide 21: Patient Disposition at Week 48

    Patient Disposition at Week 48 Eo @ & @® # Randomized 337 336 338 1011 # Treated 99.7% 99.7% 100% 99.8% # Completing Week 48 92.3% 94.6% 92.9% 93.3% # Discontinued before Week 48 Reasons for discontinuation Withdrawal by subject Adverse events Death COVID-19 related Physician decision Other? alnclud

  22. Slide 22: Baseline Characteristics of the Study Eye

    Baseline Characteristics of the Study Eye E> @ & @®D N (FAS) 336 335 338 1009 BCVA (ETDRS letters) 58.9 (14.0) 59.9 (13.4) 60.0 (12.4) |} 59.6 (13.3) Snellen equivalent 20/63 20/63 20/63 20/63 20/32 (73 to 78 letters) 14.6% 12.5% 14.2% 13.8% 20/40 or worse (S73 letters) 85.4% 87.5% 85.8% 86.2% CRT (

  23. Slide 23: PULSAR: 48-Week BCVA Results Primary Endpoint Met in Both 8mg Groups

    PULSAR: 48-Week BCVA Results Primary Endpoint Met in Both 8mg Groups Absolute BCVA 66.9 8q12 66.5 298 66.3 8q16 16 20 24 28 32 BCVA Change from Baseline wo 4 oO = o - ”n [a4 (=) = Ww 12 24 Week Diff. in LS means vs 2q8 2-sided 95% Cl 1-sided test for non-inferiority at 4-letter margin LS mean change

  24. Slide 24: Proportion of Patients Maintaining q12- and q16-Week Intervals Through Week 48

    Proportion of Patients Maintaining qi2- and q16-Week Intervals Through Week 48) nAMD 83% of 8 mg patients maintained dosing intervals 212 weeks q16 2q12 77% 83% 8q12 n=316" 8q16 n=312" All 8 mg _ n=628* Values may not add to 100% due to rounding. *Patients shortened based on DRM assessments at some

  25. Slide 25: Central Retinal Thickness

    Central Retinal Thickness Change from BL 126 28 -142 8q12 -147 8q16 24 Week Observed values (censoring data post ICE); FAS: 28 n=336; 8412 n=335; 8q16 n=338 (at baseline)

  26. Slide 26: nAMD

    N (SAF) Patients with 2 1 AE (%)* Cataract Intraocular pressure increased Retinal hemorrhage Subretinal fluid Visual acuity reduced Vitreous floaters *Any ocular treatment-emergent event in the study eye. AE, adverse event; SAE, serious adverse event; SAF, safety analysis set.

  27. Slide 27: nAMD

    N (SAF) Patients with 21 IOIAE (%)* No cases of endophthalmitis or occlusive retinal vasculitis Reported IOI terms: chorioretinitis, iridocyclitis, iritis, vitreal cells, vitritis *Treatment-emergent events.

  28. Slide 28: nAMD

    N (SAF) Patients with IOP 2 35 mmHg pre- or post-injection (%) Pre-injection IOP values were similar to baseline values at all timepoints through Week 48

  29. Slide 29: nAMD

    N (SAF) Patients with 2 1 AE (%) APTC events* Hypertension events* Non-ocular SAEs* Deaths’ *Treatment-emergent events; ‘All events. APTC, Anti-Platelet Trialists' Collaboration; SAE, serious adverse events.

  30. Slide 30: PULSAR Summary: Primary and Key Secondary Endpoints Met

    ETDRS Letters PULSAR Summary: Primary and Key Secondary Endpoints Met * 8q12 and 8q16 groups had non-inferior BCVA compared to 2q8 at Week 48 * 8q12 and 8q16 combined had superior drying compared to 2q8 at Week 16 Absolute BCVA 66.9 8q12 66.5 298 66.3 8q16 16 20 24 28 32 BCVA Change from Baseline 0

  31. Slide 31: PULSAR: 48-Week Results Majority of 8mg Patients Maintained Randomized Intervals

    PULSAR: 48-Week Results o/ Majority of 8 mg Patients Maintained Randomized Intervals Pe nAMD 83% of 8 mg patients maintained dosing intervals =>12 weeks Q16 2Q12 77% 83% 8q12 (n=316) 8q16 (n=3124) All 8 mg (n=628*) Mean 6.1 injections Mean 5.2 injections Mean 5.6 injections Values may not add to 100

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