Roche May Be First to Dry-AMD Market With Biomarker Focus
by Elizabeth Krutoholow
Roche may be able to overtake Otsuka in the race to market in geographic atrophy (GA), by leveraging a biomarker test for lampalizumab to structure a smaller pivotal trial, or to garner a breakthrough designation with the FDA, according to Bloomberg Industries. The company will update investors on plans later this year and potential acceleration will be a key focus.
GA is an advanced form of dry age related macular degeneration for which there are no approved therapies, noted Dr. Wai Wong, Chief of the Unit on Neuron- Glia Interactions in Retinal Disease at the National Eye Institute at the NIH. There is a lot of unmet medical need, he said. Roche estimates that GA affects more than 8 million people worldwide.