Eye on Five – November Edition

Trump Bump Fuels Biotech, Pharma Stocks
Pharma and biotech stocks surged in the week after Donald Trump’s election, with the OIS Index jumping 13% and the NASDAQ Biotech Index surging 11.2%. The gains have since trailed off, but the latter index was still up 8% for November at month-end. Three anticipated policy changes have fueled this surge: new tax rules to ease the repatriation of foreign-held corporate savings, which could push M&A activity; a less restrictive FDA, which could take a step forward this week with a House vote on the 21st Century Cures Act; and an easing of pressures on drug price controls.

Is Novartis Shopping Alcon?
In an interview with a Swiss newspaper, Novartis chairman Joerg Reinhardt intimated the Swiss pharma giant may be looking to sell Alcon. “In the long run, the question arises as to whether we are the best owner for Alcon,” Reinhardt told SonntagsZeitung. “Alcon has not developed over the past two years as we had expected … all options are open in the future,” he said. With annual revenues of $5.5 billion to $6 billion, Alcon could fetch $15 billion or more.

FDA Approves Allergan Gel Stent Injector System
The FDA approved Allergan’s XEN Glaucoma Treatment System – consisting of the XEN45 gel stent and proprietary XEN injector – for intraocular pressure (IOP) reduction in glaucoma. Indications are for patients who failed to achieve target IOP after surgery, in primary open angle glaucoma, and in patients with pseudoexfoliative or pigmentary glaucomas who still have high IOP despite medical therapy. The injector inserts the XEN stent through an ab interno approach, creating a new drainage channel with a permanent implant. Allergan plans to launch the XEN system in the US in early 2017.

Zeiss Gets FDA Approval for Swept-Source OCT
Zeiss received the first FDA clearance for swept-source optical coherence tomography (OCT) imaging of posterior ocular structures with its Plex Elite 9000 platform. Plex Elite 9000 also includes OCT angiography, for which Zeiss received FDA approval last year. The Zeiss Plex Elite 9000 has a limited release as an advanced research tool, and it is at the core of the Advanced Retinal Imaging Network led by Philip J. Rosenfeld, MD, PhD, at Bascom Palmer Eye Institute, University of Miami.

Santen Plans NDA after SAKURA Results
Santen plans to file an FDA new drug application early in 2017 for Opsiria (440 μg sirolimus injection) for treatment of noninfectious uveitis. The second Phase III SAKURA trial (for Sirolimus Study Assessing Double-masked Uveitis Treatment) met its primary endpoint supporting the efficacy of Opsiria. SAKURA Study 2 showed no statistically significant difference in the effect on vitreous haze between the low-dose sirolimus injection (44 μg) and Opsiria, “though clinical findings provide supportive evidence confirming the efficacy of the product,” Santen said in a press release.