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HomeminewsTGA Registers Eylea 8mg

TGA Registers Eylea 8mg

Bayer Australia has announced that Eylea (aflibercept) 8 mg is now registered by the Therapeutic Goods Administration (TGA) for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DMO) in adults.

The TGA move is based on positive results from the pivotal PULSAR and PHOTON studies.1-3

For more information, review the Eylea 8 mg Product Information or contact Bayer Medical Information on 1800 008 757.

References
1. Eylea Approved Product Information.
2. Lanzetta, P., Korobelnik, J.F., Wong, T.Y. et al.; PULSAR Investigators., Intravitreal aflibercept 8 mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase 3 trial. Lancet. 2024 Mar 23;403(10432):1141–1152. DOI: 10.1016/S0140-6736(24)00063-1.
3. Brown, D.M., Boyer, D.S., Sivaprasad, S., et al.; PHOTON Investigators. Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial. Lancet. 2024 Mar 23;403(10432):1153–1163. DOI: 10.1016/S0140-6736(23)02577-1.

Eylea is a registered trademark of Bayer Group, Germany. Bayer Australia Limited.
ABN 22 000 138 714. 875 Pacific Highway, Pymble NSW 2073.
BRA560 | June 2024 | PP-EYL_AU-0006-1