The first pre-filled syringe (PFS) specifically designed for intravitreal injection has been listed on the Pharmaceutical Benefits Scheme (PBS) for the treatment of wet age-related macular degeneration (wet AMD).1,2
On 1 September 2014, the Lucentis PFS was listed for the treatment of wet AMD alongside the Lucentis Vial on the PBS, providing the opportunity for clinicians to choose between the two presentations.1
The launch of the PFS reinforces Novartis’ commitment to local innovation in medical retina. Novartis invests more than $20 million annually in local trials in Australia. Two locally initiated Phase IV studies, FLUID and RIVAL commenced recently to answer questions posed by the Australian medical retina community. FLUID will compare treatment regimens using ranibizumab in neovascular (wet) age-related macular degeneration (wet AMD) patients: intensive (resolution of intra- and sub-retinal fluid) versus relaxed (resolution of primarily intra-retinal fluid) treatment.3
The RIVAL trial will investigate the development of new geographic atrophy in patients with neovascular (wet) age-related macular degeneration, comparing treatment with ranibizumab and aflibercept.4
“Partnering with the local medical community to answer important clinical questions demonstrates our commitment to innovation” said Nic Kurstjens, Chief Scientific Officer, Novartis Australia. “We believe continued local investment in Australian research is vital to the quality use of medicines that ultimately lead to better health outcomes for patients.”
Lucentis is the first intravitreal anti-VEGF available in Australia for four indications including the treatment of wet age-related macular degeneration (wet AMD), visual impairment due to diabetic macular oedema (DME), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularisation secondary to pathologic myopia (myopic CNV).1
References
1. Approved Product Information for Lucentis, 28 April 2014.
2. Public Summary: Summary for ARTG Entry, TGA eBS, http://www.tga.gov.au/about/website-copyright.htm, accessed 18/07/2014.
3. http://clinicaltrials.gov/ct2/show/NCT01972789?term=FLUID&rank=1 accessed 16/07/2014.
4. http://clinicaltrials.gov/ct2/show/NCT02130024?term=RIVAL&rank=2 accessed 16/07/2014.
