FDA Approvals, Highlights, and Summaries: Ophthalmology 

February 24, 2021

Enspryng (satralizumab)

Satralizumab is indicated for neuromyelitis optica spectrum disorder (NMOSD) in adults who are antiaquaporin-4 (AQP4) antibody positive. It is a humanized monoclonal antibody that targets the interleukin 6 (IL-6) receptor. Cytokine IL-6 is thought to be a key cause of NMOSD, triggering the inflammation cascade and leading to damage and disability.

Approval was based on the phase 3 trials SAkuraStar and SAkuraSky. One of the studies enrolled 83 patients, with 41 assigned to the satralizumab group and 42 to the placebo group. Among 55 AQP4-IgG–seropositive patients, relapse occurred in 11% of those in the satralizumab group compared with 43% in the placebo group; however, among 28 AQP4-IgG–seronegative patients, relapse occurred in 36% and 43%. ( N Engl J Med. November 28, 2019;381(22):2114-2124)

Another multicenter trial enrolled 95 patients who were randomly assigned to treatment (63 to satralizumab; 32 to placebo). Protocol-defined relapses occurred in 19 (30%) patients receiving satralizumab and 16 (50%) receiving placebo (P=.018). ( Lancet Neurol. May 2020;19(5):402-412)

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 thyroid eye disease (exophthalmos, proptosis).

Approval of teprotumumab was supported by the OPTIC phase 2 and 3 clinical trials (n=171). Results showed significantly more patients treated with teprotumumab (82.9%) had a meaningful improvement in proptosis (≥2 mm) compared with 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. May 4, 2017;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. October 12, 2019;394(10206):1352-1363)

Other notable 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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