FDA Drug Approvals, Ophthalmology — 2020 Midyear Review

August 14, 2020

Tepezza (teprotumumab)

Teprotumumab is a monoclonal antibody that binds insulinlike growth factor-1 receptor (IGF-1R). The mechanism of action for thyroid eye disease has not been fully characterized. It is indicated for exophthalmos and proptosis.

Approval of teprotumumab was supported by the OPTIC phase 2 and 3 clinical trials (n=171). Results showed that significantly more patients treated with teprotumumab (82.9%) had a meaningful improvement in proptosis (≥2 mm) compared with those given placebo (9.5%) (P ?.001), without deterioration in the fellow eye at week 24. Additional secondary endpoints were also met, including a change from baseline of at least 1 grade in diplopia (in 67.9% of patients receiving teprotumumab compared with 28.6% receiving placebo [P=.001]) at week 24.

( N Engl J Med 2017 May 04;376:1748-1761)

Uplizna (inebilizumab)

Inebilizumab is a monoclonal antibody that binds with high affinity to CD19, a protein expressed on a broad range of B cells, including antibody-secreting plasmablasts and plasma cells. After binding to CD19, these cells are rapidly depleted from circulation.

It is indicated for neuromyelitis optica spectrum disorder (NMOSD) [in adults who are antiaquaporin-4 (AQP4) antibody-positive. In NMOSD, approximately 80% of patients have autoantibodies to a water channel protein called aquaporin-4 (AQP4). These AQP4-IgG autoantibodies are produced by plasmablasts and plasma cells and bind primarily to astrocytes in the CNS; binding of AQP4-IgG antibodies to CNS cells is believed to trigger attacks, which can damage the optic nerve, spinal cord, and brain.

Approval was based on the N-MOmentum trial (n=230). Participants were randomly assigned to treatment and dosed, with 174 participants receiving inebilizumab and 56 receiving placebo. The randomized controlled period was stopped before complete enrollment, as recommended by the independent data-monitoring committee, because of a clear demonstration of efficacy. Twenty-one (12%) of 174 participants receiving inebilizumab had an attack compared with 22 (39%) of 56 participants receiving placebo (P <.0001).

( Lancet 2019 Oct 12;394(10206):1352-1363)

Other ophthalmology approvals

Upneeq (oxymetazoline ophthalmic) - New product for adult blepharoptosis .

Durysta (bimatoprost ophthalmic implant) - Indicated to reduce intraocular pressure in adults with open-angle glaucoma or ocular hypertension .

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