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Novartis brolucizumab 2-year data for age-related macular degeneration

  • Novartis' drug brolucizumab just showed that it wasn't any worse than a rival drug called Eylea at treating an eye condition known as age-related macular degeneration.
  • It confirmed what the company had previously found after one year, that Novartis' drug was also better at reducing retinal thickness and retinal fluid compared to Eylea, two factors that are key in reducing the symptoms of the disease.
  • Novartis plans to submit brolucizumab for FDA review by the end of 2019.

Novartis is gearing up to shake up a huge eye-drug market.

In data presented Saturday at the American Academy of Ophthalmology annual conference, Novartis' drug brolucizumab showed that it wasn't any worse than Eylea, an existing drug to treat a condition called age-related macular degeneration. The pair of late-stage trials evaluated brolucizumab over two years.

With this data in hand, Novartis plans to submit brolucizumab to the FDA for approval before the end of the year, with a potential approval in 2019.

If approved, brolucizumab would go up against Eylea and Lucentis, two treatments for AMD developed by Regeneron and Genentech/Novartis respectively that are part of the .9 billion global macular degeneration market. The drugs are all injected into the eye. Novartis' new drug would be given once every three months, while Eylea is injected once every eight weeks.

The trial also confirmed what the company had previously found in a shorter study: that Novartis' drug was also better at reducing retinal thickness and retinal fluid compared to Eylea, two factors that are important in reducing the symptoms of the disease.

Age-related macular degeneration is a leading cause of vision loss in the US in people over 50, according to the National Eye Institute. It affects more than 2 million Americans and an estimated 20-25 million globally, blurring their vision and making it harder to drive, read, and recognize faces. Patients can live with AMD for years, which means getting information on how the new drug works over time is key.

"It is important to also be able to tell the community what happens when you follow people for another year," Novartis Pharmaceuticals chief medical officer Shreeram Aradhye told Business Insider.






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Date: 16.12.2018, 15:50 / Views: 52194