FDA Approvals, Highlights, and Summaries: Ophthalmology 

February 27, 2020

Beovu (brolucizumab intravitreal)

Brolucizumab is indicated for treatment of neovascular (wet) age-related macular degeneration (nAMD). It is a vascular endothelial growth factor (VEGF) inhibitor. By inhibiting VEGF-A, brolucizumab suppresses endothelial cell proliferation, neovascularization, and vascular permeability.

Approval of brolucizumab was based on the HAWK and HARRIER phase 3 trials (n=1817) that compared intravitreal brolucizumab with aflibercept for nAMD. At 48 weeks, brolucizumab was demonstrated to be noninferior to aflibercept in mean best-corrected visual acuity. At week 16, after identical treatment exposure, fewer brolucizumab 6 mg–treated eyes had disease activity compared with aflibercept in HAWK (24% vs 34.5%; P=.001) and HARRIER (22.7% vs 32.2%; P=.002).

Ophthalmology. 2019 Dec;126(12):e95-e96

Additional 2019 Ophthalmology approvals

TissueBlue (brilliant blue G ophthalmic) is a disclosing agent indicated to selectively stain the internal limiting membrane during vitreoretinal surgery.

Soliris (eculizumab) is the first drug to gain approval for neuromyelitis optica spectrum disorder in adults who are antiaquaporin-4 (AQP4) antibody positive.

Xeomin (incobotulinumtoxinA) was approved as first-line treatment of blepharospasm.

Eylea (aflibercept intravitreal) is now approved for all stages of diabetic retinopathy.

Rocklatan (netarsudil/latanoprost) was approved for reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Avaclyr (acyclovir ophthalmic) was approved as a new dosage administration route for herpes simplex virus (HSV-1 and HSV-2).


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