Vialase Announces Positive Results of First-in-Human Study of Femtosecond Laser Image-Guided High Precision Trabeculotomy

ViaLase announced results of the first-in-human study of femtosecond laser image-guided high-precision trabeculotomy (FLigHT) performed with ViaLase technology. The results, which the company says 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 (AGS) 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," Richard Lewis, MD, chief medical officer, ViaLase, said in a company news release. "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 multicenter prospective randomized trial which is currently enrolling."

Investigators designed the 12-month, prospective, single-center, non-randomized study to evaluate safety, and also observe the 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 the 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 1 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."

ViaLase's FLigHT treatment leverages the precision and accuracy of both femtosecond laser technology and advanced visualization to provide a noninvasive procedure that can be performed by a trained doctor. A multicenter, randomized trial is currently underway to further validate the results of this first-in-human trial.