Bausch + Lomb to Initiate Series of US Clinical Trials for Technolas Teneo Excimer Laser

Bausch + Lomb announced it will initiate a series of US clinical trials to evaluate the safety and efficacy of Technolas Teneo excimer laser for vision correction surgery for myopia and myopic astigmatism. The company expects the clinical trials to begin by July 2019.

“The global LASIK market continues to grow, and the Technolas Teneo laser, which has a compact footprint, has been well received and widely adopted in more than 50 countries,” Chuck Hess, vice president and general manager, U.S. Surgical, Bausch + Lomb, said in a company news release. “Our plan to initiate a series of clinical trials, and ultimately pursue regulatory approval for this technology in the United States, is part of our commitment providing surgeons with a full suite of innovations to meet the needs of their patients.”

The system being studied will be the same as the Technolas Teneo laser (model 2) currently being sold outside the United States. Bausch + Lomb plans to file for premarket approval (PMA) of the Technolas Teneo laser from the FDA at the conclusion of the clinical trials.