- Novartis will raise new warnings of vision-related side effects for its new eye drug Beovu following a review of safety data reported by physicians.
- Arterial blockages, blood vessel inflammation or severe vision loss were reported about 10 times for every 10,000 injections in March, Novartis said. The pharma will ask the Food and Drug Administration and other regulators to add new information to the product label, which could result in a "black box" warning.
- Novartis aims to take on Regeneron's Eylea to treat the "wet" form of a condition called age-related macular degeneration, or AMD. The announcement Thursday prompted RBC Capital Markets analyst Kennen MacKay to predict the warning "will likely heavily limit Beovu to niche corners" of the eye-care market.
Eylea and Beovu both treat wet AMD, a condition caused by the growth of abnormal blood vessels in the eye that leak fluid, by blocking a protein that stimulates the formation of new blood vessels.
Novartis was hoping to take market share from Regeneron by offering a product that required less-frequent physician-administered eye injections — every two to three months compared with Eylea's maximum interval of every two months.
But with safety worries now hanging over Beovu, doing so will be a much tougher task for Novartis. The Swiss pharma company launched Beovu in October 2019, and recorded sales of $35 million by year end.
At the time of its launch, some analysts argued the less-frequent injection schedule on its label would limit uptake because some patients need treatment once a month to control their disease. In addition, even at launch, analysts had identified safety as an issue, as the initial label cautioned of inflammation and immunogenicity.
The coronavirus pandemic, meanwhile, has weighed on the ophthalmology market in particular, as some patients are reluctant to visit physicians for fear of infection. Specifically for Beovu, the need for patient monitoring post-injection has meant that "adoption of Beovu has been essentially stopped," claimed Bernstein analyst Ronny Gal in a recent note to clients.
In its new review of post-market adverse events reporting, Novartis found retinal artery occlusion, inflammation of blood vessels in the eye — known as vasculitis — or severe vision loss occurred in 8.75 to 10.08 out of 10,000 injections for five weeks spanning Feb. 28 to March 27.
Events causing severe vision loss such as uveitis or cataracts were most common, occurring at a rate of as high as 4.03 per 10,000 injections in the week of March 6.
RBC's MacKay wrote that the cases of severe vision loss and vasculitis should draw the most scrutiny from the FDA, because they haven't been reported with Eylea and other drugs using the same biological pathway such as Roche and Novartis' Lucentis and Roche's Avastin, which is used off-label.
Novartis said it will work with FDA, the European Medicines Agency and other national regulators to amend the product label, as well as change the protocols of ongoing clinical trials to prevent such adverse events. Study investigators will need to inform enrollees of the newly identified risk and ask them for consent to continue in the trials.