A new anti-VEGF drug, Beovu (brolucizumab-dbll, Novartis) gained FDA approval in October 7, 2019, expanding the portfolio of options for wet AMD. And doctors have been eager to give it a try, with an estimated 46,000 injections administered in the United States as of last week, Novartis noted in a statement.
However, on Sunday night the American Society of Retina Specialists (ASRS) shared a warning to its members: reports to the society suggest an increased risk of inflammation among patients who received Beovu. ASRS notes that, as of the drug’s approval, it has received 14 reports of vasculitis, 11 of which were occlusive retinal vasculitis—a potentially vision-threatening complication.
Concerning though the warning may be, 14 cases out of the estimated 46,000 injections “places these events at a relatively low risk ratio,” explains Mohammad Rafieetary, OD, who is a consultative optometrist at the Charles Retina Institute in Germantown, Tenn. “It has been noted in this report that the exact cause of these adverse events are unclear.”
Both the ASRS and Novartis statements remind doctors that Beovu is contraindicated for patients with active intraocular inflammation.
“Physicians should follow the guidance in the prescribing information that patients with active inflammation should not be injected with Beovu,” Novartis said in the statement.
The HAWK/HARRIER Phase 3 trials that led to the medication’s approval showed that both 3mg and 6mg regimens of brolucizumab were noninferior to aflibercept in best-corrected visual acuity change from baseline at 48 weeks. The trials also revealed a 4% rate of intraocular inflammation and a 1% rate of retinal artery occlusion—incidences that are not far from those reported by other anti-VEGF agents, Dr. Rafieetary says.1
“Patient safety is of paramount importance,” the company said in its statement. “Novartis stands behind the safety and efficacy of Beovu. In addition to our own internal assessment, we have engaged an external safety review committee to further evaluate these post-marketing cases. We will continue to share details as they become available.”
“From a personal experience standpoint, Beovu is a very effective agent for neovascular AMD, including for cases becoming recalcitrant to previous treatment with existing anti-VEGF agents,” notes Dr. Rafieetary, who is a masked subinvestigator for Novartis’s HAWK, MERLIN, KINGFISHER and RAVEN clinical trials. “Beovu or any other therapeutic agents will always come with potential risks. It is incumbent on all practitioners to consider these risks and fully inform the patient of them compared with the benefits and discuss possible alternatives of any treatment and obtain an informed consent for indicated procedural cases.”
Doctors who notice Beovu-associated inflammation should follow the patient closely with appropriate imaging, the ASRS said in the warning, as some cases can be subtle or have delayed onset.
Doctors should also report any adverse events to Novartis at 1-888-NOW-NOVA (1-888-669-6682) or the FDA via MedWatch.
|1. Dugel PU, Koh, Ogura Y, et al. HAWK and HARRIER: Phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2020;127(1):72-84.|