VISCO360 SYSTEM IS CE MARK APPROVED

The Visco360 System (Sight Sciences) is now CE Mark approved, offering ophthalmologists in the EU a clear corneal approach to canaloplasty, according to a company news release. The initial European commercial cases were presented during the European Society of Cataract and Refractive Surgeons (ESCRS) meeting in Copenhagen, Denmark.1
The Visco360 System is a fully integrated, single-handed, single-use device specifically designed for an ab interno approach to Schlemm canal using a single clear corneal incision. The system combines a custom-access cannula, a flexible microcatheter with an atraumatic tip, an internal infusion pump and viscoelastic reservoir, and a wheel that controls advancement and retraction of the microcatheter using one finger.
The Visco360 Viscosurgical System is commercially available in the United States as a manual surgical tool but is investigational for the specific indication of IOP reduction in adult, pseudophakic patients with primary open-angle glaucoma.
1. Körber N. Visco360 viscosurgical instrument for ab interno canaloplasty: technique and first results. Paper presented at: The XXXIV Congress of the ESCRS; September 12, 2016; Copenhagen, Denmark.

ROCLATAN ACHIEVES PRIMARY EFFICACY ENDPOINT IN
MERCURY 1 STUDY

Aerie Pharmaceuticals’ Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% achieved its 90-day primary efficacy results in the phase 3 Mercury 1 clinical trial. Roclatan dosed once daily demonstrated statistical superiority over both latanoprost and Aerie’s Rhopressa (netarsudil) at the primary endpoint range of baseline IOPs from above 20 to below 36 mm Hg for each of nine measured time points.
Efficacy levels were consistent across the 90-day period for all arms in the study. Mean diurnal IOP lowering with Roclatan exceeded that with latanoprost by an average of 1.9 mm Hg and exceeded Rhopressa by 2.6 mm Hg. Roclatan reduced mean diurnal IOP to 16 mm Hg or lower in 61% of patients, a significantly higher percentage than observed in the comparator arms. The most common adverse event with Roclatan was hyperemia, which was reported in approximately 50% of patients.
If Mercury 1 and Mercury 2 (an efficacy trial that commenced in March 2016) are successful, Aerie expects to file a new drug application for Roclatan at the end of 2017, according to a news release.

VIEWI DEVICE LETS PATIENTS PERFORM STATIC PERIMETRY AT HOME

The new Viewi device (Cambridge Consultants) works with a smartphone app to let patients perform a static perimetry test at home, according to a company press release. A smartphone is slotted into the portable headset, where it runs a conventional suprathreshold test in less than 5 minutes per eye. The patient presses a button that is connected to the headset via Bluetooth Smart each time he or she sees one of the flashing dots. The results of the static perimetry test are displayed in a nontechnical format on the smartphone for the patient to track and share with his or her physician.
“The Viewi system doesn’t aim to replace the current screening and management system; it’s been designed to augment the clinical tests,” noted Simon Karger, head of surgical and interventional products at Cambridge Consultants, in the press release. “Although the current clinical tests work exceptionally well, the system for glaucoma management is overloaded.”
The Viewi technology can provide an early warning system for people at risk of developing glaucoma, and it can make static perimetry accessible to more patients in developing countries, according to the company.