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After Lucentis setback, Novartis trumpets data on follow-up drug

Next gen eye treatment offers less frequent dosing


Novartis has new phase 3 data backing the efficacy of a follow-up to its blockbuster ophthalmology drug Lucentis, just after losing a UK battle to protect the brand from low-cost competition.

The experimental therapy – called brolucizumab (RTH258) – showed its was superior to a Bayer and Regeneron’s Eylea (aflibercept) in tackling a key disease activity marker in age-related macular degeneration (AMD), a leading cause of blindness, according to Novartis.

The study found that fluid in the retina was detected less often in patients treated with brolucizumab than with Eylea between weeks 36 and 48 of the phase 3 HAWK trial, which enrolled patients with the neovascular or ‘wet’ form of AMD. It’s now well established that one the targets for nAMD therapy should be a fluid-free retina.

Novartis is preparing to file for approval of brolucizumab before the end of the year, and having a new product for AMD would be a big boost to its ophthalmology portfolio as Lucentis (ranibizumab) faces stiffer competition in the marketplace.

Last week, Novartis and Bayer were defeated in a UK lawsuit – brought by a group of NHS organisations – allowing them to continue using Roche’s cheaper drug Avastin (bevacizumab) in place of Lucentis and Eylea for AMD, even though Avastin isn’t approved for the indication. Meanwhile, Eylea has been gaining ground in wet AMD thanks to less frequent dosing, accord to GlobalData.

Like Lucentis, Eylea and Avastin, brolucizumab is a VEGF inhibitor, but offers less-frequent administration with eight to 12 weeks between injections into the eye, and potentially longer if physicians use the treat-and-extend (TAE) protocol. That involves using VEGF drugs to clear the retina of fluid and haemorrhages for the first three months, and then extending treatment intervals by a couple of weeks at a time for as long as the retina remains dry and stable.

On that basis Eylea and Lucentis are currently dosed on average six and seven times a year, respectively, so it may be that brolucizumab could reduce that further. EvaluatePharma expects brolucizumab to be taken up quickly if approved, and reach sales of around $1.8bn by 2024 as a potential ‘best-in-class’ product.

The US patents on Lucentis and Eylea will both expire in 2020, and in 2022 for Lucentis and 2021 for Eylea in Europe.

In addition to nAMD, Novartis is developing brolucizumab for diabetic macular oedema, and it is also continuing to seek indications for Lucentis while it brings brolucizumab forward. The company has just announced it will file for approval of Lucentis in retinopathy of prematurity (ROP), a rare disease in premature infants that often leads to blindness, based on the results of the phase 3 RAINBOW trial.

“Despite marginally missing statistical significance for the primary endpoint of demonstrating superiority of Lucentis to laser surgery, Lucentis  was shown to be an efficacious, safe and well-tolerated treatment for infants with ROP,” according to Novartis, which says its drug could be an alternative therapy that does not involve destroying retinal tissue.

24th September 2018


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