Companies investing in the future of femtosecond laser cataract surgery

OSN discusses the latest developments with executives from the companies that are developing the femtosecond lasers for cataract surgery in the U.S.

Ocular Surgery News recently interviewed executives from the three companies that are developing femtosecond lasers for use in cataract surgery. The lasers from Alcon/LenSx, LensAR and OptiMedica are in various stages of development and approval from the U.S. Food and Drug Administration. Here is a closer look at the burgeoning technologies.

Stuart Raetzman

Alcon/LenSx

In August, Alcon completed the purchase of LenSx Lasers. The LenSx laser has received 510(k) clearance from the FDA for lens fragmentation and anterior capsulotomy.

Stuart Raetzman, vice president of global marketing and U.S. area president for Alcon, spoke with OSN about the company’s future in femtosecond cataract surgery systems.

OSN: What is your company’s approach to bringing this technology to the market within the U.S. and outside of the U.S.?

Mr. Raetzman: We will take the same approach that we take for all of our products, especially our surgical products. Alcon will be committed to having a well-trained commercial organization in place to help doctors understand the technology. We have a highly trained, highly experienced sales organization that takes the task of education seriously. Alcon conducts hundreds of training and education programs every year. We would expect the same thing here. Once a physician or a facility decides to acquire the technology, then we would be committed to training the physician and the staff, being available with customer service and dedicating ourselves to making sure that the experience is absolutely world class for that facility.

OSN: What are the clinical advantages of femtosecond cataract surgery in incision, capsulotomy, lens removal and astigmatism-correcting incisions?

Mr. Raetzman: What femtosecond lasers do really well is cut. The femtosecond laser is a cutting instrument, a fine-cutting, precision-controlled cutting instrument. In cataract surgery, those areas of the procedure that are done with cutting instruments — the capsulorrhexis, lens fragmentation — are done more consistently, with better uniformity and more predictability with the laser.

Using OCT technology optimizes the use of the tool, for example, allowing for a thinner, more consistent capsulorrhexis. The capsulorrhexis is more likely to be centered, more likely to be the perfect size, more likely to be perfectly round. If you can improve the capsulorrhexis, you can improve the entire procedure.

OSN: In what ways will femtosecond cataract surgery improve premium IOL implantation?

Mr. Raetzman: The same principle applies to premium IOL implantation. If the femtosecond laser can provide a more precise, better controlled, more predictable capsulorrhexis, then you have improved the likelihood that you are going to have a well-centered premium IOL.

OSN: What financing or reimbursement models are you investigating for making the technology affordable for surgeons and patients?

Mr. Raetzman: Alcon has a long history of introducing innovative technology in cataract surgery, and we are well aware of the economics surrounding the procedure. We understand the market very well, and we will commercialize in a way that will make the technology available to patients and commercially viable for ophthalmologists.

OSN: Will this become the new standard of care, and will it replace the phaco machine?

Mr. Raetzman: Ultrasonic energy is remarkably effective at removing tissue, but it is not used for cutting. You use the ultrasonic energy for emulsifying and removing. You use the femtosecond laser where you would have used a knife, not where you would use something to emulsify. So they are really complementary.

There are some great synergies ahead. We can really help surgeons, through training and education, through our research in terms of how to use these technologies together, but not one as a replacement for the other.

LensAR

Randy W. Frey

Randy W. Frey, CEO of LensAR, discussed the LensAR laser system. The company has received 510(k) clearance from the FDA for the LensAR laser system for anterior capsulotomy during cataract surgery and will soon submit its 510(k) application for lens fragmentation. The system is considered an investigational device for all other indications.

OSN: What has been your company’s path of development of femtosecond lasers for cataract surgery?

Mr. Frey: LensAR began in 2004 by licensing key intellectual property in the field of laser in the lens for presbyopia.

In 2006, we did our first cataract surgery capsulotomy and fragmentation in porcine eyes, and it was so compelling, we dedicated our company to the cataract surgery market first and presbyopia as a second future market.

OSN: What is your company’s approach to bringing this technology to the market within the U.S. and outside of the U.S.?

Mr. Frey: We see the U.S. market as our primary focus, but there are many opportunities outside the U.S., which we plan to capitalize on.

OSN: What are the clinical advantages of femtosecond cataract surgery in incision, capsulotomy, lens removal and astigmatism-correcting incisions?

Mr. Frey: Better predictability in outcomes, which we expect to translate into improvements in safety and efficacy, and automation, which translates into improved efficiency. LensAR’s goal is to improve efficiency for surgeons while improving on the standard of care for the patients.

OSN: In what ways will femtosecond cataract surgery improve premium IOL implantation?

Mr. Frey: Consistent-sized capsulotomy means better predictability in effective lens position and spherical equivalent and better centration with all IOLs by reducing tilt and decentration error.

Lower ultrasound power and lower trauma are expected to improve early recovery of vision and potentially reduce complications on higher-grade, more challenging cataracts.

OSN: What financing or reimbursement models are you investigating for making the technology affordable for surgeons and patients?

Mr. Frey: In general, if we deliver better outcomes and improved efficiency, the economics will work out. Patients who can pay privately, outside of Medicare, for uncovered refractive procedures and laser cuts for astigmatism are certainly in that category.

OSN: Will this become the new standard of care, and will it replace the phaco machine?

Mr. Frey: Not yet, but LensAR is much closer to this reality than any other company. We are seeing more than 90% reduction in cumulative dispersed energy for cataract grades 1 and 2 and a significant reduction in grades 3 and 4.

OSN: Are there plans to incorporate femtosecond cataract surgery with other refractive surgery procedures beyond incisional techniques?

Mr. Frey: LensAR is working on many advanced technology solutions, especially in the area of presbyopic lens correction.

OptiMedica

Mark Forchette

Mark Forchette, OptiMedica president and CEO, responded to questions from OSN in a telephone interview. The company’s Catalys Precision Laser System, currently in development, has not been cleared for use by the FDA and does not have a CE mark.

OSN: What has been your company’s path of development of femtosecond lasers for cataract surgery?

Mr. Forchette: Since the very beginning of the company in 2004, we have included femtosecond laser for refractive cataract surgery as a key target. We have leveraged our expertise in retina as a foundation in the cataract space. OptiMedica revolutionized retinal photocoagulation with the PASCAL (Pattern Scan Laser) method, which has become the new standard of care in retinal photocoagulation. Our success with PASCAL demonstrates our deep expertise in the delivery of laser with high-speed scanning, advanced control systems and user interface design, as well as our deep knowledge of laser-tissue interaction. We believe this expertise provides a significant advantage for us in cataract.

OSN: What is your company’s approach to bringing this technology to the market within the U.S. and outside of the U.S.?

Mr. Forchette: We are primarily focused on developing the best technology. Our cataract project is aimed at delivering laser cuts as precisely as possible, as we believe that laser cataract surgery is all about precision. Our second focus has been to design a system with the user experience in mind so that we deliver a system that addresses the challenges of cataract surgery and the needs of the surgeon, technician, nurse and patient.

Key innovations that we believe will separate Catalys from competing systems are the Liquid Optics interface, the interface between the patient and the system, as well as Integral Guidance, our proprietary OCT system and associated algorithms that map the ocular surfaces, create safety zones and deliver the laser very precisely. We believe that physicians will see us as a leader in these areas.

Key to bringing the Catalys system to market is that we have drawn on the insight from our medical advisory board, a domestic and international group of cataract experts who give us great insight into the way that physicians will use it and the expectations that they have.

Also key is that we are well-funded and well-positioned for a successful U.S. and international launch, which we anticipate for 2011.

OSN: What are the clinical advantages of femtosecond cataract surgery in incision, capsulotomy, lens removal and astigmatism-correcting incisions?

Mr. Forchette: A laser capsulotomy has the potential to be much more precise — more precisely sized, shaped and positioned — and tailored to the specific needs of the IOL. As an example, our clinical data shows that the average deviation in diameter of the capsulotomy from the intended diameter obtained with Catalys was 27 µm compared with the average deviation in the manual technique, which was 329 µm. This is a remarkable difference. The precision achieved with laser capsulotomy, along with our precision in capsulotomy shape and position, lets you match the capsulotomy to the lens, ultimately reducing the tilt and decentration that can lead to suboptimal outcomes. Physicians on our medical advisory board are excited about the potential of the laser capsulotomy to positively impact effective lens position and ultimately reduce residual refractive error after cataract surgery. There is also potential for reducing capsulorrhexis tags, extensions and tears.

Laser fragmentation of the lens — softening and segmenting the lens — has the potential to reduce the amount of phaco energy and time as well as reducing the number of active phaco manipulations needed to disassemble the lens.

The multiplane laser cataract incision has the potential to be more watertight than a manual incision, possibly reducing the incidence of endophthalmitis. And, lastly, OCT guidance can deliver much greater accuracy and ultimately better astigmatic correction when making relaxing incisions with a femtosecond laser than is possible with a manual incision.

OSN: In what ways will femtosecond cataract surgery improve premium IOL implantation?

Mr. Forchette: This is really about precision. Even the most highly skilled physicians are challenged to create a precisely sized, shaped and positioned capsulorrhexis consistently. The current variability in creating the capsulorrhexis is a major factor in variation in effective lens position and ultimately residual refractive error. Another exceptional precision metric from our clinical study is our performance in centration. We give the physician multiple centering options, including the dilated pupil and the limbus. For our trial, we selected centration within the dilated pupil, and our result was just an 86 µm mean deviation from perfect centration. The precision of using image-guided laser incisions should improve outcomes and consistency and will encourage more patients to opt for the premium IOL experience.

OSN: What financing or reimbursement models are you investigating for making the technology affordable for surgeons and patients?

Mr. Forchette: Our main focus currently is to make sure that the technology that we deliver provides improved outcomes for surgeons and their patients. That is the clear driver for physicians and patients when it comes to adopting new technology. And history has shown that patients are willing to pay out of pocket for technologies that deliver superior outcomes.

OSN: Will this become the new standard of care, and will it replace the phaco machine?

Mr. Forchette: Femtosecond laser will be adjunctive to phaco in cataract surgery. Laser has been extremely effective in softening even very dense nucleus and straightforward cataracts and greatly reducing the amount of phaco energy used in softer lenses, but I do think it is probably overreaching to say that the laser will eliminate phaco, the use of ultrasound energy, in all cases. It makes a dense nucleus much softer, which is a great adjunct to the disassembly of the nucleus.

OSN: Are there plans to incorporate femtosecond cataract surgery with other refractive surgery procedures beyond incisional techniques?

Mr. Forchette: There are many other possible applications, but our focus has been on developing the absolute best cataract system possible and to enhance the procedure with the laser capsulotomy, cataract incisions, relaxing incisions and by facilitating lens removal with conditioning of the lenses with segmentation and softening.

• Mark Forchette can be reached at OptiMedica, 3130 Coronado Drive, Santa Clara, CA 95054; 888-850-1230; e-mail: mforchette@optimedica.com.
• Randy W. Frey can be reached at LensAR, 250 Park Ave. South, Suite 310, Winter Park, FL 32789; 888-LENSAR1; e-mail: randy.frey@lensar.com.
• Stuart Raetzman can be reached at Alcon, 6201 South Freeway, Fort Worth, TX 76134; 800-862-5266; e-mail: stuart.raetzman@alconlabs.com.