Topcon Triton Imaging System Gets FDA Approval

■ The FDA has given 510(k) clearance to Topcon’s much-awaited DRI OCT Triton Series, an imaging system that features easy image capture and a 1-micron, 1,050-nm light source with a scanning speed of 100,000 A-scans/second. The multimodal instrument incorporates a built-in retinal camera and eye tracking during capture of selected scans, and it combines OCT imaging, color, red-free, FA, and FAF imaging with the diagnostic power of swept-source OCT, says Topcon.

In addition to anterior-segment scanning, Topcon says the Triton can visualize deeper pathology, rapidly penetrating ocular tissues such as the choroid and the sclera without being obscured by media opacities or hemorrhage. Topcon says the Triton can visualize from vitreous through to sclera at the press of a single button with high sensitivity and speed.

The instrument also features widefield OCT scanning (12 mm x 9 mm) with reference database, which Topcon says is useful in annual exams, allowing fully automated mapping and illustration of both the macula and optic disc in a single scan and potentially halving the number of scans the patient requires.

Glaucoma 360 Highlights New Treatment Developments at 7th Annual Meeting

By Nancy M. Graydon, Executive Director of Development & COO, Glaucoma Research Foundation

■ Glaucoma Research Foundation hosted the 7th Annual Glaucoma 360 New Horizons Forum on February 9th in San Francisco, California. More than 50 companies and institutions were featured during a full day of presentations, panels, and discussions with leaders from start-up companies, industry executives, ophthalmic experts, venture capitalists, and the FDA. One special focus of this year’s meeting was the use of virtual reality (VR) in glaucoma care, with presentations on VR in research and product development.

The New Horizons Forum was founded by Adrienne Graves, PhD, and Andrew G. Iwach, MD — both members of the Glaucoma Research Foundation Board of Directors — to highlight and further the advancement of new developments in glaucoma treatment. Dr. Iwach, director of the Glaucoma Center of San Francisco, explains, “New Horizons Forum brings together a wide range of potential partners focused on innovation. From a physician standpoint, we need better solutions to help patients, and this meeting fosters the necessary collaboration and partnerships needed to advance new ideas.” He adds, “The goal of Glaucoma 360 is to accelerate the process to develop new glaucoma treatments to help patients today, and ultimately find a cure.”

Iqbal Ike K. Ahmed, MD, Medical Director, Prism Eye Institute, assistant professor at the University of Toronto, and Clinical Professor at the University of Utah, delivered the Drs. Henry and Frederick Sutro Memorial Lecture, the Forum’s keynote address, titled “Interventional Glaucoma: The Why, The Who, and The How.” Dr. Ahmed’s keynote highlighted the evolving place of surgery in the glaucoma treatment paradigm, noting that the advent of microinvasive glaucoma surgery (MIGS) has ushered in new opportunities to control primary open-angle glaucoma with earlier intervention.

Thin Corneas Seen as Glaucoma Risk Factor

■ A new mouse study identifies a protein called POU6F2, which can modulate corneal thickness, as a possible culprit for causing glaucoma in humans. The finding by Emory University researchers was reported in a recent issue of PLOS Genetics.

Though many risk factors and genetic mutations have been linked to the incidence of glaucoma, an often-speculated risk factor is thin corneas. The new study suggests that genetic variations in the gene that codes for POU6F2 may affect the structure of the eye and increase a person's risk of glaucoma. Finding a genetic link between glaucoma and thin corneas has been difficult because a mix of multiple genes and environmental conditions contribute to the overall task of the researcher. The role of POU6F2 in corneal development and thickness in mice, however, does point to the gene as a possible risk factor for glaucoma in humans that merits further investigation.

"Previous work by collaborators at Harvard and Duke identified many of these genetic factors; however, we currently only can account for approximately 7% of the genetic risk for glaucoma," researcher Eldon E. Geisert, PhD, said in a news release. "We chose to use a well-defined mouse system to define genetic elements that can be directly related to human disease. It is our hope that defining this link between central corneal thickness and glaucoma will aid in early detection of glaucoma and eventually treatments to halt the progression of this disease."

A Second iStent for Refractory Glaucoma

■ Glaukos Corporation, an ophthalmic medical technology company focused on developing novel products and procedures designed to transform the treatment of glaucoma, said it has submitted an Investigational Device Exemption (IDE) application to the FDA seeking authorization to study its iStent infinite Trabecular Micro-Bypass System. The iStent infinite is designed for use as a standalone procedure to reduce elevated IOP in refractory glaucoma patients. Each iStent infinite stent is approximately 0.36 mm x 0.36 mm, or about one-third the size of iStent, which the company believes is the smallest medical device ever approved by the FDA.

In the IDE application, Glaukos proposes to conduct a prospective, multicenter, single-arm clinical trial to evaluate safety and performance of the iStent infinite. The primary endpoint is proposed to be a 20% or greater reduction in IOP from baseline at 12 months on the same or fewer medications. Glaukos plans to use the trial results as the basis for seeking FDA clearance.

In other Glaukos news, the company has applied to the FDA for pre-market approval of the iStent inject Trabecular Micro-Bypass Stent, a next-generation, much smaller iteration of the original iStent designed to reduce IOP in combination with cataract surgery.

Imprimis Now Offers Two Drugs on Shortage List

■ Imprimis Pharmaceuticals, an ophthalmology-focused pharmaceutical company, said it is now dispensing the glaucoma medications preservative-free dorzolamide and a preservative-free dorzolamide/timolol formulation after dorzolamide and the commercial products, Cosopt and Cosopt PF (Akorn), were added to the FDA drug shortage list. Akorn reports that Cosopt PF is once again available and in stock at all pharmacies. Cosopt PF is the preservative-free form of Cosopt and is packaged in cartons of 60 single-use vials. The 2 sterile topical medications were prescribed approximately 4 million times during 2017, according to IMS data accessed by Imprimis. GP