FDA Drug Approvals, Ophthalmology — 2022 Midyear Review

August 24, 2022

Vabysmo (fraicimab)

Vabysmo (faricimab) – First bispecific antibody for treatment of adults with neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME). Faricimab targets 2 distinct pathways – angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). By inhibiting VEGF-A, faricimab suppresses endothelial cell proliferation, neovascularization, and vascular permeability. By inhibiting Ang-2, faricimab promotes vascular stability and desensitizes blood vessels to the effects of VEGF-A. Ang-2 levels are increased in some patients with nAMD and DME.

Approval was based on the phase 3 TENAYA and LUCERNE studies for wet AMD and the YOSEMITE and RHINE studies for DME.

The multicenter trials sites (n = 271) randomly assigned patients with wet AMD (TENAYA: n = 334 faricimab; n = 337 aflibercept) and (LUCERNE: n = 331 faricimab; n = 327 aflibercept) to determine noninferiority. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline. BCVA with faricimab was noninferior to aflibercept in both studies, and ocular adverse events were comparable between faricimab and aflibercept. Lancet 2022 Jan 21

The YOSEMITE and RHINE studies (353 worldwide sites) randomized adults with vision loss due to center-involving diabetic macular edema to receive intravitreal faricimab 6 mg every 8 weeks, faricimab 6 mg per personalized treatment interval (PTI), or aflibercept 2 mg every 8 weeks up to week 100. The primary endpoint was mean change in best-corrected visual acuity at 1 year. Patients were randomly assigned to faricimab every 8 weeks (YOSEMITE, n = 315; RHINE, n = 317), faricimab PTI (n = 313; n = 319), or aflibercept every 8 weeks (n = 312; n = 315). Vision gains and anatomic improvements with faricimab were achieved with adjustable dosing up to every 16 weeks. Lancet 2022 Jan 21

Kimmtrak (tebentafusp)

Tebentafusp is the first drug approved for treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma (mUM). It is a first-in-class bispecific protein comprising a soluble T-cell receptor (TCR) fused to an anti-CD3 immune-effector function that specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. Immune-mobilizing monoclonal TCRs against cancer (ImmTAC) molecules bind cells that present a peptide derived from an antigen of interest, and they recruit T-cells to lyse the target cells.

Approval of tebentafusp was based on the results of the phase 3 IMCgp100-202 clinical trial, which evaluated overall survival (OS) of tebentafusp compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in patients with previously untreated mUM. The trial randomized 378 patients in a 2:1 ratio to either tebentafusp or investigator’s choice. Results demonstrated OS was 73% in the tebentafusp group compared to 59% in the investigator’s-choice group (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine) at 1 year (P<0.001). Progression-free survival was also significantly higher in the tebentafusp group than in the control group (31% vs. 19% at 6 months; P=0.01). N Engl J Med. 2021 Sep 23;385(13):1196-1206

Other ophthalmology approvals

Acuvue Theravision with Ketotifen (ketotifen, drug-eluting contact lens) – Daily disposable contact lenses indicated for the prevention of ocular itch caused by allergic conjunctivitis and to provide vision correction in patients aged 11 years and older who do not have red eyes, who are suitable for contact lens wear, and who do not have more than 1.00 D of astigmatism.

Beovu (brolucizumab intravitreal) – New indication approved for diabetic macular edema.


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