New glaucoma devices push the boundaries

“Big Medtech” is on the hunt. But while the ophthalmology device giants all see start-ups and small-device makers as a valuable source of innovation and technology, they are not all looking for the same technologies, or even the same stages of development.

Abbott Medical Optics, Santa Ana, CA, is casting the widest net. Jane Rady, divisional vice president, business development, said the company is particularly interested in micro-invasive glaucoma surgery (MIGS). Because Abbott already has a shunt on the market, any glaucoma investment would need to be a completed proof-of-concept study. But in other areas, such as cataract, the company is willing to join forces at an earlier stage.

Carl Zeiss Meditec, Dublin, CA, wants to provide complete solutions from diagnosis to treatment. That means any potential acquisitions must first fit the company’s business model.

“If a technology fits and integrates, we take part at a very early stage,” said Ralf Kuschnereit, PhD, president and CEO. “But if it is more of an addition to our existing portfolio, we would be looking at a more mature stage.”

Alcon Laboratories, Fort Worth, TX, is interested in opportunities in the surgical glaucoma space, said Greg Kunst, global marketing director, surgical glaucoma.

“We are constantly scanning the marketplace, looking for the right opportunity,” Kunst said. “However, proof of concepts are not enough without a clear line of site to regulatory and reimbursement approval."

Lumenis, San Jose, CA, always has new technology acquisitions on its mind. Experience has shown that many of the most successful medtech developments come from small start-ups, said Kfir Azoulay, vice president and general manager of the ophthalmology unit. But decisions to invest are heavily influenced by the potential regulatory burden.

“In principle, we want companies as close to commercialization as possible,” Azoulay explained. “But (it) is a matter of the product type. If we are looking at a category 1 versus a category 3 product, regulatory would have a major impact because it takes a very different investment to bring a 510(k) product to market versus a PMA.”

Company focus

There is no shortage of companies trying to build new devices, new technologies, and new markets-and to catch the attention of larger companies looking to expand their own portfolios. Six of the hottest young medtechs in glaucoma landed coveted slots at Glaucoma 360. Five have stents and one has a novel IOP-monitoring device. All of the companies have devices approved outside the United States, but only one has successfully gained FDA approval.

AqueSys

Xen is a portfolio of permanent gelatin implants to be injected into the subconjectival space and bypass potential outflow obstructions. The ab interno procedure can be used with all stages of glaucoma with or without cataract surgery. A multicenter international trial showed mean IOP reductions of 30% to 38% for a mean post-op pressure of 13.9 mm Hg to 15.6 mm Hg. Results are stable with up to 3-year follow-up.

Glaukos

The iStent is the first MIGS device to be approved for commercialization in the United States. The ab interno device drains into the suprachoridal space, has two CPT codes and is being reimbursed by all 13 Medicare carriers. Two follow-on devices are currently in trials for FDA approval.

InnFocus

The MicroShunt I drains into the subconjunctival space to bypass both the trabecular meshwork and venous resistance to mimic trabeculectomy results with IOPs of 14 mm Hg or less. Ab externo placement takes a mean of 12 minutes by anterior segment surgeons with or without cataract surgery. Two-year data shows a 92% success rate, with 82% of patients off glaucoma medications and no long-term adverse events.

Ivantis

The Hydrus Microstent is an ab interno device implanted using cataract surgical incisions. Insertion adds about 2 minutes to the cataract procedure. The device creates a scaffolded channel draining into Schlemm’s canal. A 2012 trial report trial showed “acceptable” IOP one-year post implantation for all 69 patients with mild-to-moderate open-angle glaucoma. Comparative effectiveness studies against the Glaukos iStent are under way outside the United States.

Sensimed

Triggerfish is a wearable, disposable IOP sensor that transmits 24-hour IOP profiles for as long as one year. The sensor allows normal daytime activities and undisturbed sleep with high intra-individual reproducibility. Changes in IOP pressure can help clinicians accurately track treatment results and progression to better personalize treatment. The device is expected to enter the U.S. market later this year with CPT code and reimbursement pathway in place.

Transcend Medical

The Cypass Micro-Stent is designed to exploit the opportunity for glaucoma treatment during cataract surgery. The stent drains into the suprachoroidal space. In combination with phaco, CyPass showed a mean 35% reduction in IOP and a 50% reduction in medication use at 12 months. The COMPASS study, due to complete enrollment later this year, will be the largest MIGS trial to date in the United States.