) 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
). All three carry a Zacks Rank #1 (Strong Buy).
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