Novartis last week faced a surprise safety setback for new eye drug Beovu, but, after its initial review, the company is standing behind the risk-benefit profile for the drug.
In a Monday update, the drugmaker said Beovu's prescribing info describes a 4% risk of intraocular inflammation and a 1% rate of retinal artery occlusion. The company is digging into safety data following a communication last week from the American Society of Retina Specialists detailing 14 cases of retinal vasculitis for Beovu patients, 11 of which were occlusive retinal vasculitis that can lead to vision loss.
“We believe the incidence of these events remains consistent with or below the package insert,” the company said in its Monday update.
Most of the cases have started after patients’ first or second injection of the wet age-related macular degeneration (AMD) drug, Novartis said. The company has instructed doctors to advise patients to seek care immediately if they experience redness in the eye, light sensitivity, pain or changes in vision. The drug also shouldn’t be used in patients with intraoccular inflammation.
Aside from its own review, the company is working with its data monitoring committee for ongoing global trials of Beovu, and it's brought in an external review group to look at the cases. Drug authorities in the U.S., Europe, Switzerland and Australia know about the review, and Novartis said it’s getting in touch with other regulators.
Last Sunday, the American Society of Retina Specialists detailed the serious side effects to members, and, following the communication, several doctors said they would stop using the new medicine, preferring instead to stick with wet AMD options including Regeneron's Eylea and Roche's Lucentis.
Following a recent call with a retina expert, Jefferies analyst Biren Amin wrote up details of one of his conversations. The doc has paused his use of Beovu and would need more information before he'd start up usage again, Amin wrote.
"He considers the efficacy benefit of Beovu as incremental, which may not be worth the potential safety risks,” the analyst added.
All things considered, Amin wrote that Beovu's initial adoption will be “very limited” and that Eylea should be able to hold its market share.
That's not the tune Novartis was singing ahead of the safety setback. On the company's fourth-quarter earnings call in late January, pharma chief Marie-France Tschudin told investors the company was off to a "great start" with Beovu's launch, considered a critical one for the Swiss drugmaker. The company had heard positive customer feedback and seen “very strong uptake” from retina specialists, she added.