ZURICH, Nov 14 (Reuters) - Patients who had certain eye problems before they were treated with Novartis’s Beovu had a higher risk of suffering from vision-threatening conditions after treatment, the Swiss drugmaker said on Saturday, based on a safety review.
The review follows a warning issued by the American Society of Retinal Specialists in February about instances of intraocular inflammation, some of which led to severe vision loss, in patients using Beovu.
The drug, which Novartis touts as a potential $1-billon-dollar-plus product annually, was approved last year for treatment of wet age-related macular degeneration (AMD), though it has trailed sales expectations in part due to the safety concerns.
According to Novartis’s review, among 12,000 patients treated with Beovu, the highest observed risk for experiencing retinal vasculitis and/or retinal vascular occlusion in the six months after first treatment was prior intraocular inflammation and/or vascular occlusion in the 12 months before the first Beovu injection.
The observed overall risk rate of 0.46% for all Beovu-treated patients increased to 3.97% in people who had the conditions before treatment, Novartis said.
Global regulators have approved updated safety guidelines for using Beovu, as Novartis’s review aims at identifying ways to prevent cases where severe vision loss occurs.
“Novartis is confident that Beovu continues to represent an important treatment option for patients with wet AMD, with an overall favorable benefit/risk profile,” the Basel-based company said.
As the population ages and suffers eye problems, the market to treat AMD is among the medical industry’s most competitive, with drugs including Lucentis -- sold by Roche in the United States and Novartis in Europe -- and Regeneron’s Eylea racking up billions of dollars in sales.
New products are in the works, as well, including drugs as well as innovations aiming to reduce the number of yearly injections direct into the eye.
Reporting by John Miller; Editing by Kim Coghill
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