Back to top

FDA Approves Novartis' Simbrinza

Read MoreHide Full Article

Novartis (NVS - Free Report) recently announced that the US Food and Drug Administration (FDA) has approved Simbrinza Suspension for the reduction of elevated intraocular pressure (IOP) in patients suffering from primary open-angle glaucoma or ocular hypertension.

We note that the only modifiable risk factor for glaucoma, which leads to blindness, is elevated IOP. Novartis stated in its press release that glaucoma is the second-leading cause of preventable blindness across the globe.

Simbrinza combines brinzolamide and brimonidine tartrate. The FDA approval was based on encouraging data from two pivotal phase III studies (n=1300) wherein Simbrinza was evaluated for safety and efficacy for over three months.

We are encouraged by the recent bout of regulatory approvals at Novartis. In Mar 2013, the European Commission approved Jetrea intravitreal injection (ocriplasmin) for the treatment of vitreomacular traction (VMT) and macular hole.

Affecting 250,000 to 300,000 people in Europe, VMT causes sight-threatening symptoms, which might result in irreversible vision loss. So far, people suffering from VMT had only surgery as a treatment option for this eye disease.

The approval was based on results from pivotal studies, which demonstrated that patients treated with Jetrea successfully achieved resolution of VMT and closure of macular holes compared to placebo on the 28th day of treatment.

We note that Novartis caters to the eyecare market through its division Alcon, which accounted for 18% of total sales in 2012. The recent approvals should further boost segmental sales.

Novartis carries a Zacks Rank #3 (Hold). Pharma stocks, which currently look more attractive include Vertex Pharmaceuticals (VRTX - Free Report) , UCB SA (UCBJF - Free Report) and Alnylam Pharmaceuticals (ALNY - Free Report) . All three carry a Zacks Rank #1 (Strong Buy).

More from Zacks Analyst Blog

You May Like