The glaucoma space has been dominated by a host of products designed to lower intraocular pressure (IOP) – minimally invasive glaucoma surgery (MIGS) devices and stents among them. However, a few outliers in the growing glaucoma surgical device space – a $706 million market in 2019, according to Market Scope – have reported encouraging results by taking different approaches. Here’s a look at some.
Neuromodtronic GmbH has developed a device that uses electrical stimulation to not only prevent further optic nerve damage, but also to restore lost vision.
The Eyetronic System uses gentle electrical pulses to stimulate the optic nerve. CEO Karl Schweitzer said electrical stimulation produces a three-fold effect: It “ignites” the retinal ganglion cells, preventing further deterioration; “cell metabolism comes back”; and degenerated nerve fibers “sprout and restore,” restoring lost function.
Five-hundred patients have received treatment with Eyetronic without any significant adverse effects, he said. Late 2019 data revealed that of 72 treated eyes, about two-thirds evidenced continued benefit at 12-month follow-up. “No further disease progression was observed,” noted Schweitzer. Results also showed partial visual-field restoration in 39% of treated eyes.
Belkin Laser, the company behind a one-second direct selective laser trabeculoplasty (DSLT), announced results from its first-in-human trial. Subjects with open-angle glaucoma who received treatment with Belkin’s laser therapy saw a 27% reduction in IOP, with no serious adverse events, according to CEO Daria Lemann-Blumenthal.
Minimally Invasive Micro Sclerostomy
Nir Israeli, CEO of Sanoculis, described his company’s alternative to MIGS: minimally invasive micro sclerostomy (MIMS). During the less-than-one-minute procedure, a surgeon creates a sclerocorneal drainage channel to reduce IOP. The channel enables long-lasting, fluid control.
Israeli says MIMS has been performed on about 140 patients to date. IOP was reduced by 53% at six months.
MicroOptx’s Beacon Aqueous Microshunt (BAM) implant targets refractory glaucoma by shunting aqueous humor from the anterior chamber to the surface of the eye. The company is recruiting up to 90 patients for a US clinical trial]. If all goes well, MicroOptx hopes to expand the indication to treatment of normal-tension and primary angle-closure glaucoma, according to company CEO Chris Pulling.
Studies Show Long-Term Data
ELT Sight CMO Matilda Parente reported long-term benefits of the company’s ExTra Excimer Laser Trabeculostomy (ELT) method. Five-year data show treatment with ELT reduced IOP similarly when used on its own or with cataract surgery (38% and 37%, respectively). The company plans to release eight-year data in the near future. It also expects to submit its investigational device exemption (IDE) application to the US Food and Drug Administration this year and begin clinical trials thereafter. ELT Sight received its CE mark in 2014.
Like ELT Sight, Ivantis looks forward to seeing longer-term data on its Hydrus Microstent, a MIGS device that received FDA approval to treat mild to moderate primary open-angle glaucoma in conjunction with cataract surgery.
Three-year results from the Global SPECTRUM patient registry, which included over 900 recruited patients, showed mean IOP dropped 20% in patients who had concurrent cataract surgery and 30% in patients who received stand-alone microstent placement. Results in both groups were consistent at one, two, and three years. Ivantis Chief Science Officer Brent Trauthen, MSc, said the company intends to follow up again with these patients at year five.
As the glaucoma device market continues to evolve, device manufacturers are researching new ways to stand out in a competitive market. How they approach this challenge will be interesting to watch over the next three to five years.
These companies reported their updates at the 2020 Glaucoma 360 New Horizons Forum February 7 in San Francisco.