Study Shows Superior Success Rate for ExTra ELT Compared With Trabectome in Patients With Glaucoma Plus Cataract Surgery
LOS ANGELES & MUNICH--(BUSINESS WIRE)--Dec 3, 2019--
ELT Sight, Inc. today announced that in the largest published study to date on excimer laser trabeculostomy (ELT), the ExTra ELT procedure plus cataract surgery was superior to ab interno trabeculectomy with the Trabectome plus cataract surgery. The 245-patient study, titled “ Success of combined cataract extraction plus excimer laser trabeculotomy exceeds that of combined ab interno trabeculectomy with the trabectome or cataract extraction alone,” was published online in the journal International Ophthalmology.
Patients in the retrospective, non-randomized, comparative single surgery center study (Hamburg, Germany) underwent one of three procedures: combined ELT plus cataract surgery, trabeculectomy with the Trabectome device plus cataract surgery, or cataract surgery alone.
At 1-year postoperative, ELT plus cataract surgery significantly reduced intraocular pressure (IOP) and medication use, which are two major and challenging treatment goals for cataract patients with glaucoma. Additionally, ExTra ELT plus cataract surgery was significantly superior in Kaplan-Meier survival analysis at 1 year compared to the other two techniques. The significantly longer mean survival time for the ExTra ELT group persisted beyond the study period in the post-hoc analysis in the comparison with the Trabectome plus cataract surgery and the cataract surgery alone groups.
Authors Lidija Jozic, Joachim Magner, Jens Funk and Marc Töteberg-Harms stated in the discussion of their findings that “thermal approaches can induce scarring and thus limit long-term success as shown by the Kaplan-Meier statistics when comparing phaco-ELT and phaco-aiT [ab interno trabeculectomy].”
Regarding safety, no serious complications occurred in any of the three groups perioperatively and during the follow-up period. Additionally, none of the treated eyes required a subsequent surgery to lower the IOP within the 12-month follow-up period.
“In this largest published study to date on excimer laser trabeculostomy, ExTra ELT safely lowered IOP below the mid-teens and reduced medication use by nearly two-thirds,” said Matilda Parente, MD, Chief Medical Officer of ELT Sight.
“This is welcome news for surgeons seeking a non-thermal, implant-free alternative for their cataract patients with mild-to-moderate glaucoma,” Dr. Parente added.
Glaucoma is the third leading cause of blindness worldwide, and the number of affected individuals is growing as the population ages. Current treatment options, including daily eye drops and invasive shunts and stents, are suboptimal for patients and providers. ELT is a completely implant-free microinvasive glaucoma surgery that was first used clinically in Europe in 1997. This outpatient procedure has shown superior results and a favorable safety profile in European studies with sustained, multi-year lowering of IOP and medication use. It is not yet available in the United States, and clinical studies in the United States are expected to begin in 2020 following a regulatory-approved pathway for ExTra ELT.
About ELT Sight
ELT Sight, Inc., based in Los Angeles and Munich, Germany, is focused on effective, safe and longer-term microinvasive glaucoma surgery with its ExTra excimer laser trabeculostomy (ELT) procedure. Sustained intraocular pressure reduction and decreased medication use have been shown across multiple European studies. The product received a CE Mark in 2014. ELT Sight plans to begin clinical studies of ExTra ELT in the United States in 2020. ELT Sight was spun-out of MLase AG, a global leader in the development and manufacturing of innovative laser systems. For more information visit https://www.eltsight.com
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CONTACT: Michelle Linn
KEYWORD: GERMANY EUROPE UNITED STATES NORTH AMERICA CALIFORNIA
INDUSTRY KEYWORD: OPTICAL HEALTH SURGERY CLINICAL TRIALS
SOURCE: ELT Sight, Inc.
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PUB: 12/03/2019 08:30 AM/DISC: 12/03/2019 08:30 AM