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NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

EYLEA 2 mg offers established experience for the realities of clinical practice
1,2

EYLEA 2 mg is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD).1

EYLEA 2 mg T&E Q4–Q16 efficacy

is demonstrated by pivotal clinical trials

 

  • Vision gains can be maintained with proactive treatment extension in 2- or 4-week increments up to Q16

*After 3 initial monthly doses, the EYLEA 2 mg treatment interval is extended to 2 months. The treatment interval can then be further extended up to 16 weeks, using proactive T&E dosing.1 Please see the EYLEA 2 mg Summary of Product Characteristics for full details of the licensed posology.

EYLEA 2 mg has demonstrated efficacy in clinical trials
3–6

VIEW 1 & 2
pivotal trials demonstrated the efficacy of EYLEA 2 mg and the potential for extended dosing3,4

Primary endpoint: proportion of patients maintaining VA at 52 weeks compared with baseline

  • Comparable VA gains were achieved with EYLEA 2 mg vs. ranibizumab1,2

 

Mean change in BCVA from baseline to week 96

VIEW 1 & 2 change in BCVA

Adapted from Heler JS, et al, 2012 & Schmidt-Erfurth U, et al. 2014

 

In Year 2, EYLEA 2 mg dosing switched from Q8 to ‘capped PRN’ up to Q12, based on individual response:3,4

  • Extended dosing intervals achieved
     during Year 2 in 84.1% of patients3,4
  • Mean number of injections at Week 96 was
    11.2 with EYLEA 2 mg and 16.5 with ranibizumab
    3,4

 

*48% (247/511) of patients in the Q8 arm received 3 injections or fewer (Q12) in Year 29

†Please see the EYLEA 2 mg Summary of Product Characteristics for full details of the licensed posology. 
‡The dosing regimen for ranibizumab used in the VIEW trial programme does not represent its current recommended treatment frequency, which varies according to response.3,9 Please consult the ranibizumab Summary of Product Characteristics for further information.

ALTAIR shows that vision gains from baseline can be maintained with proactive treatment extension in 2- or 4-week increments up to Q16 with EYLEA 2 mg
5
*

Primary endpoint: mean change in BCVA (ETDRS letters) from baseline to Week 52 with EYLEA 2 mg

Mean change in BCVA from baseline to Week 96

ALTAIR change in BCVA

Adapted from Ohji M, et al. 2020.

 

*In ALTAIR, T&E was initiated after 3 monthly loading doses and a dose at Week 16.5 Please see the EYLEA 2 mg Summary of Product Characteristics for full details of the licensed posology.

 

Over 96 weeks of treatment, patients on EYLEA 2 mg required just 10.4 injections on average:

  • The mean number of injections at Week 52 was 7.2 for the 2-week adjustment group and 6.9 for the 4-week adjustment group
  • The mean number of injections at Week 96 was 10.4 for both the 2-week and 4-week adjustment groups

ARIES shows that early-start T&E with EYLEA 2 mg can deliver similar vision gains from baseline to late-start T&E
6
*
†

Primary endpoint: mean change in BCVA (ETDRS letters) from randomisation (Week 16) to Week 104 with EYLEA 2 mg

ARIES change in BCVA

Adapted from Mitchell P, et al. 2021.

 

Per protocol set. Data from the graph above includes all patients who were allocated to each group, regardless of whether they extended or not.6

 

In the early-start T&E group, injection intervals could be extended by 2-week increments after the dose at Week 16. In the late-start T&E group, EYLEA 2 mg was administered every 8 weeks until Week 52, after which the injection interval could be extended by 2-week increments.

Early-start T&E with EYLEA 2 mg was non-inferior to late-start T&E for mean change in BCVA from Week 16–104 (p=0.0162).

  • The mean number of injections at Week 52 and Week 104 was 7.1 and 12.0 for early-start T&E and 8.0 and 13.0 for late-start T&E, respectively

 

*Analyses were conducted as a LOCF from the per-protocol set. Intervals >16 weeks were considered minor deviations and were included in the per-protocol set. In ARIES, early-start T&E was initiated after 3 monthly loading doses and a dose at Week 16; late-start T&E initiated after 1 year of fixed dosing at Q8 (following 3 monthly loading doses and a dose at Week 16).6
†After 3 initial monthly doses, the EYLEA 2 mg treatment interval is extended to 2 months. The treatment interval can then be further extended up to 16 weeks using proactive T&E dosing.1
‡In ARIES, early-start T&E was initiated after 3 monthly loading doses and a dose at Week 16; late-start T&E was initiated after 1 year of fixed dosing at Q8 (following 3 monthly loading doses and a dose at Week 16).6

RWE supports T&E dosing with EYLEA 2 mg
7,8

Moorfields RWE: extended treatment intervals achieved with EYLEA 2 mg in clinical trials are reflected in clinical practice

Primary outcome: proportion of eyes achieving at least one Q12 retreatment interval in first 2 years

Mean VA (ETDRS letters) through Year 2

RWE primary outcome

Adapted from Fu DJ, et al. 2023.

68% of eyes were able to achieve a Q12 dosing interval within the first 2 years of treatment with EYLEA 2 mg⁷

Established safety profile
1

EYLEA 2 mg has an established safety profile in nAMD, gained from extensive clinical and real-world experience

Safety profile in RCTs:
VIEW 1 and 2, ALTAIR and ARIES support the established safety and tolerability profile of EYLEA 2 mg3–6

Safety profile in Fu DJ,
et al.
real-world study:
No specific safety data were reported in this study.7

See the EYLEA 2 mg Summary of Product Characteristics for further details of the safety profile.

Dosing

Diagrams illustrating the posology in nAMD1

MoA

Innovative molecular design and mechanism of action1,10–14

Safety

Established safety profile in nAMD1

Abbreviations

BCVA, best-corrected visual acuity. CI, confidence interval. ETDRS, Early Treatment Diabetic Retinopathy Study. LOCF, last observation carried forward. MoA, mode of action. nAMD, neovascular age-related macular degeneration. PRN, pro re nata (as needed). Q4, every 4 weeks. Q8, every 8 weeks. Q12, every 12 weeks. Q16, every 16 weeks. RCT, randomised controlled trial. RWE, real-world evidence. SD, standard deviation. T&E, treat and extend. VA, visual acuity.

References

  1. EYLEA® 40 mg/mL Summary of Product Characteristics.
  2. Bayer. Data on File. EYLO020.
  3. Heier JS, et al. Ophthalmology 2012;119:2537–2548.
  4. Schmidt-Erfurth U, et al. Ophthalmology 2014;121:193–201.
  5. Ohji M, et al. Adv Ther 2020;37:1173–1187.
  6. Mitchell P, et al. Retina 2021;41:1911–1920.
  7. Fu DJ, et al. Eye (Lond) 2023;37:779–784.
  8. Eleftheriadou M, et al. Ophthalmol Ther 2018;7:361–368.
  9. Richard G, et al. Ophthalmology 2015;122:2497–2503.
  10. Fauser S & Muether PS. Br J Ophthalmol 2016;100:1494–1498.
  11. EMA. EYLEA EPAR assessment report 2012. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/eylea. Accessed: September 2024.
  12. Papadopoulos N, et al. Angiogenesis 2012;15:171–185.
  13. Kanda A, et al. Sci Rep 2015;5:17946.
  14. Amadio M, et al. Pharmacol Res 2016;103:253–269.

PP-EYL-GB-2337 | September 2024

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