Bayer drug enters phase III for diabetic macular oedema
pharmafile | April 11, 2011 | News story | Sales and Marketing | Bayer, Lucentis, ophthalmology
Bayer and partner Regeneron have begun late stage trials for their VEGF Trap Eye candidate for diabetic macular oedema.
The first phase III trial in diabetic macular oedema (DME) is being led by Bayer and has started in Australia with similar trials to be conducted in Europe and Japan.
A second study led by US-based biotech Regeneron is expected to start in North America and other countries start later this year.
In January Roche and Novartis’ VEGF Trap Eye drug Lucentis (ranibizumab) gained a European licence to treat DME.
It is already the standard of treatment for wet aged-related macular degeneration (AMD), and made Roche $1.45 billion in sales last year.
Bayer’s candidate will be looking to challenge Lucentis for both of its licences.
The German pharma’s original collaboration with Regeneron began in 2007 and both companies have high hopes of multiple licences for the drug.
The partnership started with phase III trials comparing its candidate with Lucentis for use the use in wet AMD, and produced strong results late last year.
One year later the collaboration extended to DME and in 2009 the two companies once again extended their agreement to include trials for central retinal vein occlusion (CRVO).
Dr. Kemal Malik, head of global development at Bayer said: “After reporting positive results from our global phase III programme (VIEW 1 and VIEW 2 studies) for the treatment of the neovascular form of wet AMD, we are pleased to start a phase III programme with VEGF Trap-Eye in DME which may help to address this significant unmet medical need.”
Bayer and Regeneron’s drug is believed to work by inhibiting the vascular endothelial growth factor (VEGF), potentially decreasing the oedema.
DME is a common complication of diabetic retinopathy and involves fluid collection in the macula.
It is the most prevalent cause of moderate vision loss in patients with diabetes and the number of patients are growing as diabetes becomes more prevalent.
Ben Adams
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