New GA Treatment with Izervay TGA Approved

Izervay received regulatory approval based on the global GATHER1 and GATHER2 clinical trials, in which it successfully met its primary endpoints by significantly reducing the rate of GA lesion growth compared with sham treatment.^1,2

Over 12 months, Izervay demonstrated a mean reduction in GA lesion growth of 35% in the GATHER1 trial and 18% in GATHER2.³ Sustained efficacy was evident over two years of follow-up, with clinical benefit observed as early as six months following the first injection.^1,2,4

The availability of this therapy in Australia will empower us to offer patients a new treatment option and opens the door to further advancements in retinal disease management

Izervay was consistently well tolerated, with fewer than 2% of participants discontinuing treatment due to adverse events.^1,2

“The recent registration of Izervay marks a pivotal milestone for the Australian ophthalmology community and, most importantly, for patients living with geographic atrophy,” said Professor Robyn Guymer, Deputy Director, Centre for Eye Research Australia and Professor of Surgery (Ophthalmology), University of Melbourne.

“For too long, GA has remained an area of significant unmet need, with patients facing progressive and irreversible vision loss without a viable treatment option. Izervay’s  approval brings new hope and a tangible step forward in our ability to intervene in this common, devastating cause of vision loss.”

Prof Guymer continued, “As a clinician, I am encouraged by the momentum in GA research and the promise Izervay holds in slowing disease progression. The availability of this therapy in Australia will empower us to offer patients a new treatment option and opens the door to further advancements in retinal disease management.”

GA is an advanced and irreversible form of age-related macular degeneration that causes progressive vision loss.⁵ In Australia, GA is estimated to affect up to 100,000 people.^6,7

Nirelle Tolstoshev, General Manager of Astellas Pharma Australia said that “without timely intervention, approximately 66% of people with GA become legally blind or severely visually impaired – a devastating outcome that profoundly impacts independence and quality of life. ^8,9

“This is an underserved patient population, who currently have limited treatment options. We are proud that Astellas’ innovation in ophthalmology will potentially help patients remain independent for longer”.

Izervay, a complement C5 inhibitor, significantly slowed the progression of GA lesions. By blocking C5 in the complement cascade, it stops the production of harmful complexes that are key drivers of retinal cell degeneration, thereby helping to delay visual impairment.^3,10

Astellas is now working to bring this important treatment to eye care professionals, patients and caregivers to support the management of GA.

References

1. Khanani AM, Patel SS, Jaffe GJ, et al. GATHER2 trial investigators. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. Lancet. 2023 Oct 21;402(10411):1449-1458. doi: 10.1016/S0140-6736(23)01583-0.
2. Jaffe GJ, Westby K, Rezaei KA, et al. C5 inhibitor avacincaptad pegol for geographic atrophy due to age-related macular degeneration: A randomized pivotal phase 2/3 trial. Ophthalmology. 2021 Apr;128(4):576-586. doi: 10.1016/j.ophtha.2020.08.027.
3. IZERVAY (avacincaptad pegol intravitreal solution) Prescribing Information. October 2025.
4. Khanani AM, et al. GATHER2: Two-Year Data. Presented at AAO 2023 127th Annual Meeting. San Francisco, CA. 3-6 November 2023.
5. Boyer DS, et al. The pathophysiology of geographic atrophy secondary to age-related macular degeneration and the complement pathway as a therapeutic target. Retina. 2017 May;37(5):819-835. doi: 10.1097/IAE.0000000000001392.
6. Macular Disease Foundation Australia. Everything you need to know about age-related macular degeneration. Available at mdfoundation.com.au/news/everything-you-need-to-know-about-amd [accessed: October 2025].
7. Keel S, Xie J, Dirani M, et al. Prevalence of age-related macular degeneration in Australia: The Australian National Eye Health Survey. JAMA Ophthalmol. 2017 Nov 1;135(11):1242-1249. doi: 10.1001/jamaophthalmol.2017.4182.
8. Keenan TDL, Cukras CA, Chew EY. Age-related macular degeneration: Epidemiology and clinical aspects. Adv Exp Med Biol. 2021;1256:1-31. doi: 10.1007/978-3-030-66014-7_1.
9. Colijn JM, Liefers B, Klaver CCW; EyeNED Reading Center and EYE-RISK Consortium. Enlargement of geographic atrophy from first diagnosis to end of life. JAMA Ophthalmol. 2021 Jul 1;139(7):743-750. doi: 10.1001/jamaophthalmol.2021.1407.
10. Desai D, Dugel PU. Complement cascade inhibition in geographic atrophy: a review. Eye (Lond). 2022 Feb;36(2):294-302. doi: 10.1038/s41433-021-01765-x. Epub 2022 Jan 9.
11. Ayoub T, Patel N. Age-related macular degeneration. J R Soc Med. 2009 Feb;102(2):56-61. doi: 10.1258/jrsm.2009.080298.