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New incision system for presbyopia surgery receives CE mark
Phase 2 regulatory trials in the United States are expected to begin before the end of the year.
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The European Union granted the CE mark to newly customized components of an incision system used for implanting the PresView scleral implants, the makers of the system announced.
The PresView scleral implants, formerly known as Scleral Expansion Bands, were developed by Presby Corp. Refocus Group acquired Presby Corp. in March and is now developing the implants under a strategic partnership with CIBA Vision.
According to Refocus Group, the implants received CE mark certification in Europe in 1998. CIBA Vision, Refocus Group’s current strategic partner, plans to market the PresView under its own CE mark certification, which was expected to be completed within a few weeks, according to Refocus Group.
Terry Walts, president and CEO for Refocus Group, told Ocular Surgery News that the recently issued CE mark, which the company received in July, covers a redesigned PresView automated incision handpiece and blade. The devices are used in conjunction with a basic ultrasound mapping system that images the eye to determine the sites for implanting the devices.
PresView system
According to Richard Keates, MD, medical director and a member of the board of directors for Refocus Group, the PresView system was designed to correct presbyopia based on the theory proposed by Ronald Schachar, MD. The theory states that the crystalline lens continues to grow throughout life, becoming too large for the eye around age 45. At that time, the ciliary muscles become slack and weaken, reducing the eye’s ability to alter the shape of the crystalline lens and thus accommodate.
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Based on that theory, the PresView scleral implants are designed to stretch the tissue surrounding the crystalline lens outward, restoring the tone of the ciliary muscles and their ability to accommodate the lens, he said.
The PresView implants must be placed in scleral pockets at a depth of about 400 µm, usually 3 mm to 4 mm from the limbus, Dr. Keates said.
He said all clinical cases to date have been done using diamond knives to make the incision pockets that hold the implants. He said the original implantation procedure works, but the results were variable in the past because it was highly dependent on surgical skill.
The new PresView system is composed of an automated incision handpiece with a disposable curved blade used to make four pockets in the sclera, one for each of the four implants.
The handpiece is placed on a mark made at the site and properly aligned. A foot pedal then activates the blade to make the incision, Mr. Walts said.
The new automated technology is intended to make the surgical incisions as reproducible and consistent as possible, he said.
Trials continue
According to Mr. Walts, the company plans to initially launch the PresView System with CIBA Vision, the company’s strategic partner (or with the eventual buyer of CIBA’s surgical business), at several “seeding” clinics in several European countries this year.
The company also expects to launch the system either commercially or clinically in Canada, depending on the outcome of talks with Health Canada.
Mr. Walts said the PresView implant was also approved under the old implantation protocol in South Korea, South Africa and several South American countries. He said the timing of the launch of the new incision system outside of Europe has not yet been determined.
The PresView implants remain in clinical trials in the United States. Mr. Walts said the phase 1 regulatory trial required by the U.S. Food and Drug Administration has been completed, and the company expects to begin phase 2 trials this year.
Mr. Walts noted the phase 2 trial will include the new incision system, but it was not used in the phase 1 trial.
For the phase 2 trial, the company expects to enroll 150 patients in the first part of the study. Of these, 100 patients will be implanted with the devices while the remaining 50 patients will serve as controls. After 6 months follow-up, the company will ask to treat the remaining 50 control patients, Dr. Keates said.
Pending the outcome, Dr. Keates said, the company will then seek FDA permission to increase the study population to include between 300 and 350 patients.
“While investigational surgeries on older patients (greater than 60 years of age) have produced excellent results, we will initially target relatively younger presbyopic patients (from 45 to 60) to avoid dealing with cataracts and other issues,” Mr. Walts said.
For Your Information:
- Terry Walts, president and CEO of Refocus Group, can be reached at 10300 North Central Expressway, Suite 104, Dallas, TX 75231; 214-368-0200; fax: 214-368-0332.
- Richard Keates, MD, medical director and a member of the board of directors for Refocus Group, can be reached at New York Eye & Ear Infirmary, 310 E 14th St., 403 South, New York, NY 10003; 212-979-4410; fax: 212-353-5772.
- Refocus Group Inc., developers of the PresView System, can be reached at 10300 North Central Expressway, Suite 104, Dallas, TX 75231; 214-368-0200; fax 214-368-0332; e-mail: info@refocus-group.com; Web site: www.refocus-group.com.