ViaLase announces positive results for first-in-human study of femtosecond laser image-guided high-precision trabeculotomy

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. (Adobe Stock image)

ViaLase Inc. today announced positive results of the first-in-human study of femtosecond laser image-guided high-precision trabeculotomy (FLigHT) performed with the ViaLase technology.

According to the company, 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 (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 of ViaLase Inc, said in a statement. "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."

The company noted that 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," Thomas W. Samuelson, MD, founding partner and attending surgeon of Minnesota Eye Consultants and lead investigator on the FLigHT trial, said in a news release. "I look forward to additional research that further validates these results, which are promising."

According to ViaLase, its 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, randomly assigned trial is currently underway to further validate the results of this first-in-human trial.