Femtosecond laser interface yields incisive incisions

Rochester, NY-Bausch + Lomb and Technolas Perfect Vision (TPV) hope the new femtosecond laser platform (Victus) unveiled last month at the European Society of Cataract and Refractive Surgeons meeting will replace existing femtosecond laser systems and allow surgeons to perform precise cataract, refractive, and therapeutic procedures within a single platform.

The product of a partnership between Bausch + Lomb and Munich, Germany-based TPV, the new femtosecond laser platform features a proprietary curved patient interface controlled by intelligent pressure sensors, designed to reduce applanation of the cornea, minimize corneal deformation and epithelial rippling, and allow for three-dimensional imaging, said Robert E. Grant, chief executive officer of Bausch + Lomb Surgical, in an interview with Ophthalmology Times.

The new femtosecond laser platform is not yet FDA approved.

It is exactly the sort of "paradigm-shifting" technology Bausch + Lomb hoped to elicit from its 2009 joint venture with 20/10 Perfect Vision AG, Grant said.

The companies announced last month they had entered a definitive agreement in which Bausch + Lomb has the option to purchase all outstanding and unowned shares of TPV in a $604.5 million deal, with certain conditions. Grant declined to discuss other details of the arrangement.

The companies plan to present the new femtosecond laser platform and early clinical data this month at the annual meeting of the American Academy of Ophthalmology in Orlando, and at the Asia-Pacific Association of Cataract and Refractive Surgeons in Seoul, South Korea.

A precise procedure

Early data suggest femtosecond laser surgery allows surgeons to create a more precise, controllable, and centered capsulotomy than with manual procedures, with less phaco energy used during lens fragmentation.

On its Web site, TPV said its system can perform anterior capsulotomy, lens fragmentation, corneal incisions, and arcuate incisions. Compared with a manual technique, the system demonstrated "highly accurate and predictable anterior capsulotomy diameter . . . with negligible deviation from the intended diameter of 5.5 mm."

It also provided improved centration and circularity, TPV said.

TPV filed in March for FDA 510(k) clearance for capsulotomy. Also in March, the companies announced Bausch + Lomb would globally distribute the laser system, which will be manufactured in Munich. The companies expect to receive the CE mark before the end of this year.

While femtosecond laser technology seems to offer many advantages over manual techniques, its cost presents a considerable hurdle for physicians. However, its precision is generating "a high degree of excitement" within the industry, Grant said.

"We know that femtosecond laser technology isn't inexpensive; it's still very expensive for doctors to integrate into their practices," Grant said.

However, its higher degree of accuracy is signaling a paradigm shift within ophthalmology, the likes of which he has not seen in his 20 years in the industry, he said.

"It's the most significant change in cataract surgery in 40 years, since the advent of phacoemulsification," he said. "I think you can expect to see other applications for this technology going forward."

Grant declined to discuss other technology in the TPV-partnership's pipeline, but said future products will need to account for patients with multiple eye conditions as the baby-boomer population ages.

"The implication of how we deal with that at a patient level is very significant," he said. "We believe we will need advances that not only make surgery easier for the doctor but make for a better patient experience, and a better patient outcome."

Future advancements should focus on improving patient experiences and outcomes for such areas as cataracts, presbyopia, age-related macular degeneration, diabetic retinopathy, and diabetic macular edema, Grant said.

"We feel strongly that the future of ophthalmology is around age- and diabetes-related eye conditions," he said.