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EMA committee supports Simbrinza safety, efficacy for glaucoma
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Alcon announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency supports the safety and efficacy of brinzolamide eye drops suspension for adult patients with open-angle glaucoma or ocular hypertension, according to a press release.
Brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL (Simbrinza, Alcon) combines two agents already approved for the treatment of elevated IOP. It is indicated for the reduction of elevated IOP in patients whose monotherapy did not provide sufficient outcomes.
The company performed two, pivotal 6-month phase 3 clinical trials in patients with open-angle glaucoma or ocular hypertension (n = 1,450) to assess mean diurnal IOP change from baseline to 3-month follow-up, with evaluation of safety and supportive efficacy through 6 months.
In the first study, the combined therapy yielded significant IOP-lowering effects compared with either brinzolamide or brimonidine at month 3, signaling a 23% to 34% reduction from baseline in IOP. Mean diurnal IOP reduction was greater among patients treated with the combined therapy (7.9 mm Hg) vs. brinzolamide (6.5 mm Hg) or brimonidine (6.4 mm Hg) treatment groups, according to the release.
The second study showed that the IOP-lowering effect was non-inferior to brinzolamide 10 mg/mL and brimonidine 2 mg/mL when administered concomitantly. Similar data were observed for the mean diurnal IOP reduction at 3 months.
The most common adverse events were ocular hyperemia and ocular allergic type reactions, according to the release.