ReST committee provides update on brolucizumab
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Brolucizumab injections may be associated with intraocular inflammation, with or without retinal vasculitis, and patient selection should take this into account, according to a speaker.
“Intraocular inflammation alone may often be managed with topical steroids, but optimal treatment for vasculitis remains unknown. This post-approval analysis is unable to assess rates or long-term outcomes, and further studies are indicated,” Paul Hahn, MD, said at Retina Subspecialty Day at the virtual American Academy of Ophthalmology meeting.
The American Society of Retina Specialists Research and Safety in Therapeutics (ReST) committee began to receive reports of intraocular inflammation alone and retinal vasculitis in patients who underwent injections of Beovu (brolucizumab, Novartis) following its FDA approval for neovascular age-related macular degeneration in October 2019. To date, the committee has received 120 reports, Hahn said.
In a subset of patients through May 2020, the committee received reports of intraocular inflammation alone in 49 eyes of 45 patients. The inflammation was typically mild to moderate in the anterior chamber and vitreous, often appearing in both, but more commonly with posterior involvement. Vision loss was relatively modest, often returning to baseline levels, and most patients were treated with topical steroids, he said.
Through April 2020, the committee received reports of retinal vasculitis in 26 eyes of 25 patients. These patients showed a more precipitous loss of vision that did not recover, with 46% of eyes losing more than three lines of vision and 35% of eyes losing more than six lines of vision, he said.
“Multiple, often aggressive, treatment modalities were employed, and it is unclear which, if any, were beneficial. The optimal treatment for this condition remains unknown,” he said.
The ReST committee recommended that informed consent should include the benefit-risk profile based on this information, and patient selection should be considered with this altered risk profile. Additionally, before every brolucizumab injection, a careful examination for inflammation is indicated, and surgeons should discuss appropriate warning signs with patients, Hahn said.
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Hahn P. Update from ReST committee. Presented at: American Academy of Ophthalmology annual meeting; Nov. 13-15, 2020 (virtual meeting).
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