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Novartis Terminates Three Beovu Studies in Ocular Disorders Citing Patient Safety

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  • Novartis AG (NYSE: NVS) has announced that three Phase 3 studies evaluating Beovu (brolucizumab) in patients with retinal diseases will be terminated early after more frequent dosing intervals were associated with higher rates of intraocular inflammation.

  • The MERLIN study and the RAPTOR and RAVEN studies will be stopped. “All other relevant ongoing trial protocols will be amended to discontinue 4-week dosing intervals after the loading phase,” a company press release said.

  • In reporting 1-year results of the 2-year MERLIN study of brolucizumab vs. Regeneron Pharmaceuticals Inc’s (NASDAQ: REGN) Eyelea aflibercept in patients with wet age-related macular degeneration and retinal fluid, higher rates of intraocular inflammation, including retinal vasculitis and retinal vein occlusion, were seen in the brolucizumab group.

  • The RAPTOR and RAVEN studies were undertaken to assess the safety and efficacy of brolucizumab vs. aflibercept in patients with visual impairment due to macular edema secondary to branch retinal vein occlusion or central retinal vein occlusion, respectively.

  • Both included six initial monthly injections and will be stopped “in the interest of public safety,” the release said.

  • “Physicians should not treat patients with Beovu 6 mg at intervals less than two months beyond the first three doses,” the release said,

  • The company also added that it would pursue updating prescribing information for the drug worldwide.

  • Price Action: NVS shares are up 0.6% at $88.91 during the premarket session on the last check Tuesday.

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