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Monday / February 17.
HomeminewsBeovu (Novartis) Achieves TGA Registration for Wet AMD

Beovu (Novartis) Achieves TGA Registration for Wet AMD

The Therapeutic Goods Administration (TGA) has registered Beovu (brolucizumab) solution for injection for the treatment of wet (neovascular) age-related macular degeneration (nAMD). Beovu is the first approved anti-VEGF in Australia to offer the ability to maintain eligible wet AMD patients on a three month dosing interval directly after the monthly loading doses.

Beovu is the first approved anti-VEGF in Australia to offer the ability to maintain eligible wet AMD patients on a three month dosing interval directly after the monthly loading doses

“Beovu is a testament to our commitment here at Novartis to reimagine medicine for patients living with wet age-related macular degeneration” said Richard Tew, General Manager of Novartis Pharmaceuticals Australia and New Zealand. “We are delighted that Beovu is now registered in Australia.”

“Ophthalmologists welcome the news of the TGA approval of Beovu (brolucizumab). We look forward to accessing this drug to treat our patients with wet age-related macular degeneration which is a leading cause of blindness in Australia,” said Clinical Associate Professor of Sydney University and vitreoretinal ophthalmologist and surgeon, Dr Andrew Chang.

The regulatory approval of Beovu was based on findings from the Phase III HAWK and HARRIER clinical trials, in which Beovu demonstrated non-inferior best-corrected visual acuity (BCVA) change from baseline at year one (week 48) versus aflibercept.1 At year one, over half of patients were maintained on the three-month dosing interval (56% in HAWK and 51% in HARRIER). The remaining patients in the study were treated on a two-month dosing schedule.1

Macular Disease Foundation Australia CEO, Dee Hopkins said, “Trials have shown that this new therapy may extend the duration between treatments for some patients with neovascular AMD. We hope that real world outcomes will result in reduced treatment burden on patients and improve persistence rates for sight saving treatment.”

Wet age-related macular degeneration is a chronic, degenerative eye disease caused by an excess of VEGF, a protein that promotes the growth of abnormal blood vessels underneath the macula,2 the area of the retina responsible for sharp, central vision.3 Affecting approximately 133,000 Australians,4 wet AMD can ultimately cause blindness and a loss of independence, by affecting the ability to read, drive, recognise faces and perform activities that require detailed vision.3

Novartis is committed to ensuring patient access to Beovu and will work closely with all stakeholders to help improve the lives of Australians living with eye diseases.

 

 

 

References

  1. Dugel P, et al. HAWK and HARRIER: Phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration [published online ahead of print]. Ophthalmology. 2019.
  2. Qazi Y, et al. Mediators of ocular angiogenesis. J. Genet. 2009;88(4):495-515.
  3. Macular Disease Foundation Australia. Macular Degeneration. Available from https://mdfa-s3fs-prod.s3-ap-southeast-2.amazonaws.com/s3fs-public/MDBooklet_2017-04_WEB.pdf (accessed: September 2019).
  4. Macular Disease Foundation Australia. Macular degeneration research update December 2017.