May 29, 2021
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Novartis halts three Beovu studies, cites patient safety

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Three phase 3 studies of brolucizumab in patients with retinal diseases will be terminated early after more frequent dosing intervals were associated with higher rates of intraocular inflammation, Novartis announced.

The MERLIN study and the RAPTOR and RAVEN studies, whose methods all include periods of 4-week dosing intervals of Beovu (brolucizumab), will be stopped. And, “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 6 mg every 4 weeks vs. aflibercept 2 mg every 4 weeks in patients with wet age-related macular degeneration and retinal fluid, Novartis said in the release that higher rates of intraocular inflammation, including retinal vasculitis and retinal vascular occlusion, were seen in the brolucizumab group.

The RAPTOR and RAVEN studies were undertaken to assess 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 2 months beyond the first three doses,” the release said, adding that the company will pursue updating prescribing information for the drug worldwide.

 

References:

Assessing the efficacy and safety of brolucizumab versus aflibercept in patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (RAPTOR). https://clinicaltrials.gov/ct2/show/NCT03802630. Accessed May 28, 2021.

Assessing the efficacy and safety of brolucizumab versus aflibercept in patients with visual impairment due to macular edema secondary to central retinal vein occlusion (RAVEN). https://clinicaltrials.gov/ct2/show/NCT03810313. Accessed May 28, 2021.

Study of safety and efficacy of brolucizumab 6 mg dosed every 4 weeks compared to aflibercept 2 mg dosed every 4 weeks in patients with retinal fluid despite frequent anti-VEGF injections (MERLIN). https://clinicaltrials.gov/ct2/show/NCT03710564. Accessed May 28, 2021.