Monday, December 23, 2024

Vialase announces positive results of first-in-human study of femtosecond laser image-guided high-precision trabeculotomy (flight)

ViaLase, Inc, a clinical stage medical technology company focused on addressing unmet needs in the conventional glaucoma treatment paradigm with the development of a truly non-invasive image-guided femtosecond laser treatment to enhance glaucoma patient care, today announced positive results of the first-in-human study of femtosecond laser image-guided high-precision trabeculotomy performed with the ViaLase technology. The results, which indicate FLigHT’s potential as a safe and effective treatment option for primary open angle glaucoma (POAG), were presented at the 2023 American Glaucoma Society meeting in Austin, Texas.

“We are encouraged by the results of this study, which validate the safety of the ViaLase technology in performing FLigHT in patients with glaucoma,” said Richard Lewis, MD, chief medical officer, ViaLase, Inc. “We look forward to continuing this important research, with the ultimate goal of bringing a safe and effective noninvasive treatment to glaucoma patients, supported by a multi-center prospective randomized trial which is currently enrolling.”

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Investigators designed the 12-month, prospective, single-center, non-randomized study to evaluate safety and also observe the intraocular pressure (IOP)-lowering effect of the FLigHT treatment. Nine patients (15 eyes) with open angle glaucoma or ocular hypertension received the non-incisional procedure after medication washout.  During the 12 months of this study, investigators reported no adverse events related to FLigHT treatment and observed a reduction in mean IOP at 12 months. Additionally, 100% of eyes did not require IOP-lowering medication after one year, and gonioscopy revealed no evidence of scarring at the site of treatment at the same time point.

“The possibility of a non-incisional glaucoma treatment that safely delivers meaningful IOP reduction is an exciting one,” said Thomas W. Samuelson, MD, founding partner and attending surgeon of Minnesota Eye Consultants and lead investigator on the FLigHT trial. “I look forward to additional research that further validates these results, which are promising.”

SOURCE: PR Newswire

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