LOS ANGELES & MUNICH--(BUSINESS WIRE)--In a first-of-its-kind comprehensive review article outlining the current literature with ten clinical studies of more than 800 eyes, results of multiple independent studies demonstrated that Excimer Laser Trabeculostomy (ELT) was as effective or better than other forms of microinvasive glaucoma surgery (MIGS) in reducing intraocular pressure (IOP), with sustained IOP lowering to the mid-teens. The article, titled “Current Review of Excimer Laser Trabeculostomy,” was published in the BioMed Central journal Eye and Vision and authored by Georges M. Durr, Marc Toeteberg-Harms, Richard Lewis, Antonio Fea, Paola Marolo and Iqbal Ike K. Ahmed.
ELT Sight, Inc. is commercializing ExTra ELT, the device currently used for ELT in Europe, which has already received a CE mark. The company is expanding its European sales activities with its German partner MLase and proceeding with regulatory filings for the device with the U.S. Food and Drug Administration in preparation for anticipated 2020 clinical trials in the United States.
In the review article of non-industry funded studies from independent investigators at more than a dozen centers across multiple countries including Italy, Germany, Switzerland and Spain, use of the IOP-lowering device following an established method in open-angle glaucoma patient populations demonstrated a degree of IOP lowering equal or superior to those achieved with other MIGS. The results were reproducible across the centers, with significant, durable IOP reduction that in some studies lasted to 5–8 years. Complication rates were low, both when used as a stand-alone procedure and in combination with cataract surgery.
“ELT is readily adoptable by surgeons, can be combined with cataract surgery and is one of the least invasive methods, even among MIGS. These studies show that without leaving a device behind, ELT offers a bleb-free alternative that can achieve sustained IOP lowering to the mid-teens,” said lead study author Georges Durr, MD, FRCSC from the Université of Montréal, CHUM hospital.
Among the demonstrated advantages of the ELT device over other MIGS, the article notes its ease of use, less scarring than results from traditional thermal lasers, and, with lower hyphema risks compared to ablative procedures, potentially less secondary synechia to the angle. The randomized controlled trial as well as prospective, retrospective and other studies showed that ELT decreased glaucoma medication usage almost exclusively, with few intraoperative or postoperative risks, none of which were considered serious.
“Surgeons looking for a laser treatment option for the trabecular meshwork at the time of cataract surgery will be happy to hear that not only does one exist, but there are years of data demonstrating IOP-lowering with very low complication rates,” added Arsham Sheybani, MD, Associate Professor of Ophthalmology at Washington University School of Medicine in St. Louis, MO, who was not involved in the study.
More recently, ELT Sight announced that in the largest published study to date on ELT, the ExTra ELT procedure plus cataract surgery was superior to ab interno trabeculectomy with the Trabectome plus cataract surgery. At 1-year postoperative in 245 cataract patients with glaucoma, ELT plus cataract surgery significantly reduced IOP and medication use. ExTra ELT proved superior in Kaplan-Meier survival analysis to trabeculectomy with the Trabectome device plus cataract surgery or to cataract surgery alone.
“This sweeping review and recent data from the largest published study on ELT clearly show that through deep experience with this method and extensive use with our device, ExTra ELT reduces IOP as well as or more effectively than other MIGS with low risk to patients,” said Matilda Parente, MD, Chief Medical Officer of ELT Sight. “We look forward to bringing ExTra ELT into clinical testing in the U.S. to offer cataract patients with glaucoma a treatment option that restores the natural outflow of the eye without leaving a device behind or destroying a critical part of the eye anatomy,” added Dr. Parente.
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 eye pressure-lowering ExTra ELT device following the 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, please visit https://www.eltsight.com and follow @ELTSight on Twitter and LinkedIn.