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Novel technologies range from invasive to non-invasive approaches
Representatives from industry met to describe their company’s new devices, both invasive and non-invasive for treating glaucoma. Some of the highlights follow.
Belkin Laser Ltd.
Daria Lemann-Blumenthal, LLB, EMBA, is CEO of Belkin Laser, Ltd., updated the audience on the status of the company’s automated non-invasive, non-contact direct selective laser trabeculoplasty device, that is activated by one press of a button. The device delivers 100 spots to the trabecular meshwork through the limbus rather than through the cornea in 1 second.
The 6-month results of the first trial in 15 patients with intraocular pressures (IOP) of 22 mmHg and higher showed a 22% decrease in IOP with the application of 1 millijoule or higher of energy; a subgroup of patients treated with 1.4 millijoules had an IOP decrease of 27%. The numbers of medications needed decreased from 1.6 at baseline to 0.4 at 6 months, with no serious adverse events, she reported.
“Our goal is to bridge the gap between the enormous number of patients with glaucoma and the limited number of ophthalmologists by enabling ophthalmologists to treat many more patients with our simple, intuitive procedure for open-angle glaucoma and angle-closure glaucoma,” she said.
ELT Sight Inc.
A 308-nanometer excimer laser (ExTra ELT laser) used for ab interno trabeculostomy is ready for clinical trials. The laser is used in standalone cases to reduce IOP and after phacoemulsification, said Matilda Parente, MD, chief medical officer of ELT Sight Inc.
The procedure is performed in patients with mild-to-moderate glaucoma through a 0.8-mm clear corneal incision. After a viscoelastic fills the anterior chamber, the probe (external diameter, 500 microns) is inserted. The laser (spot size, 210 microns) is applied to the trabecular meshwork to create 10 microchannels about 500 microns apart extending to Schlemm’s canal. Blood reflux and bubbles visible at the end of the procedure indicate that the channel patency. The decrease in IOP occurs within the first couple of weeks postoperatively, Dr. Parente explained.
“The IOP drops differ from other microinvasive glaucoma surgeries in that they are consistent, reproducible, and durable, with decreases of about 8 to 10 mmHg, and the procedure restores the physiology conventional outflow,” she said. The presubmission filing has been submitted to the FDA for an investigation device exemption.
Eyetronic therapy takes a step past medical and surgical IOP control by using non-invasive electrical stimulation of the optic nerve applied before the optic nerve suffers irreparable damage and intervention is still possible, said Karl Schweitzer, co-founder and CEO of Neuromodtronic GmbH.
Application of electrical impulses in animal studies has shown reignition of nerve cells, restoration of functions, and neural restoration of the structure of the nerve fibers. These findings were seen with the Eyetronic device; patients undergoing this stimulation perceived light flashes, a clear sign of a signal in the cortical area, Mr. Schweitzer said.
During the procedure, patients wear stimulation goggles that have four electrodes embedded in the frame. More than 500 patients have undergone this procedure. The data show an improvement in visual fields and the mean defect improving from 8.2 to 4.5 decibels during a 3-month follow-up period. Twelve-month data from 72 eyes showed that about two-thirds have benefited from non-invasive nerve stimulation with no further disease progression and partial restoration of the visual field.
“Based on these data, we will engage in further investigations of the technology used in glaucoma patients,” he said. An international glaucoma trial is planned.
The Hydrus Microstent is an 8-mm FDA-approved stent that facilitates aqueous outflow after insertion in Schlemm’s canal during cataract surgery.
The company is looking to the future with the recognition that glaucoma is a lifetime event that deserves long-term follow-up, according to Brett Trauthen, MSc, from Ivantis, and the company is continuing to follow the 556 patients who participated in the Horizon Trial.
“Eighty-eight percent of patients were followed at year 3 and 84% at year 4. We expected to follow over 80% of patients at 5 years. This gives us a unique opportunity to evaluate the long-term effects of the Horizon study compared to the standard of care in patients with mild-to-moderate glaucoma,” he said.
The 2-year study results showed significant improvements in response to therapy and significant increases in the reduction of IOP. The 3-year results continued to show significant reductions in patients who are medication-free. Most patients do not need medications to control IOP and there is no change in the IOP in these patients between 2 and 3 years. The device is stable in the late follow-up. The device has not caused significant decreases in the endothelial cells, he reported.
A significant reduction in the risk for incisional glaucoma surgery was seen at the 3-year time period and appears to continue into years 4 and 5, Mr. Trauthen noted.
The Beacon Aqueous Microshunt, previously called the Brown Aqueous Microshunt, shunts directly to the tear film and bypasses the episcleral venous system. The device is aimed at patients refractory to glaucoma treatment. Two studies of the device are underway; in the US study, 6 patients have no light perception and 1 light perception but no hand motions.; in a German study, 19 patients are implanted.
Results are indicating a good safety profile with no infections; diminished flow or an occluded flow channel are the most common adverse events.
Data are available for 12 patients at 1 year who were fully medicated at baseline with a mean IOP of 23 mmHg. At 12 months, the patients are unmedicated with an IOP of about 14 mmHg. Five of the 7 US patients are medication-free with IOPs of 14 mmHg or lower; 16 of 19 German patients are medication-free with an IOP at or below target.
“The ocular surface has benefited from treatment resulting from both bathing the cornea with aqueous and removing the IOP-lowering medications,” said Chris Pulling, CEO of MicroOptx.
A change in the manufacturing process from a square to a round flow channel has reduced the risk of device occlusion.
The multicenter Beacon Study of 90 patients should begin in spring 2020 to look at IOP reductions at 1 year; patients will be followed for 5 years.
The company’s MIMS (Minimally Invasive Micro Sclerostomy) procedure creates a drainage channel to reduce IOP in glaucoma patients.
“The procedure is fast, simple, stentless, and has efficacy comparable to trabeculectomy,” said Nir Israeli, CEO and co-founder of Sanoculis. The system includes a foot switch, controller, and disposable handpiece unit with a drill.
The procedure, requiring 1 minute, includes creation of a side port and injects viscoelastic under the conjunctiva. The surgical instrument is inserted through the port to the angle; the foot pedal is depressed to create the drainage channel with the drill, after which the intraocular fluid drains from the anterior chamber into the subconjunctival space.
The procedure is indicated for most patients who need glaucoma surgery and has a promising safety profile, Mr. Israeli reported. In India, 140 patients underwent the procedure to date; the IOP reduction at 12 months was 52% of the baseline value, with concomitant reduction in medications of 67%. At 6 months and 50% at 12 months; similar results were seen in Europe.
A clinical study for the US is planned for 2020.