LADARVision approval leads business news at AAO

The FDA approval, which was announced during the meeting, is an industry first for a wavefront-guided custom ablation system.

ORLANDO, Fla. — Alcon’s LADAR-Vision platform for wavefront-guided customized refractive surgery received approval from U.S. regulators, the company announced at the American Academy of Ophthalmology meeting here.

The approval, which came on the Friday before the official start of the meeting, kicked off the world’s largest gathering of ophthalmic physicians and industry on a positive note. Other FDA approvals, launches and industry activity during the meeting resulted in a more positive atmosphere than at other recent ophthalmic meetings.

The LADARVision 4000 excimer laser and the LADARWave wavefront measuring device comprise the first system to receive Food and Drug Administration approval for wavefront-guided customized LASIK surgery, according to the company.

The FDA approved the system for the correction of myopia between the ranges of 0 D to -7 D with up to 0.5 D of cylinder, according to Steven Bott, vice president of laser refractive research and development. He explained the practical application of the approval range.

“The agreement between the phoropter and the wavefront measurement has to be within a diopter of sphere and within a diopter of cylinder. These are the conditions that the FDA has approved for the device.” Mr. Bott said. “In practice, you can type into the system the phoropter measurement and then the cylinder, which is the main constraint as you can only go up to 0.5 D of cylinder on the manifest refraction per the approval. However, if, for example, the wavefront measurement is less than 1.5 D (up to 1.49 D as read on the wavefront device), 1.49 D of cylinder would still be acceptable and would still be treated.”

“The treatment is based on the wavefront reading,” said Laurent Attias, Alcon’s director of surgical marketing, refractive.

“Wavefront-guided customized laser surgery has the potential to improve visual acuity and enhance overall vision quality as compared with today’s conventional LASIK,” said Steven Brint, MD, a clinical associate professor of ophthalmology at Tulane University School of Medicine, who was one of the clinical investigators of the system. “Treating optical aberrations, which impact low-contrast visual acuities such as night driving, will improve the patient’s quality of vision.”

In the multicenter clinical trial for LADARVision CustomCornea, 139 of 426 eyes were treated for nearsightedness. Of those patients treated, 98.6% achieved 20/40 or better and 79.9% achieved 20/20 or better, according to an Alcon press release.

Clinical trials are ongoing for the treatment of myopic astigmatism, hyperopia with and without astigmatism and other ocular irregularities, according to Alcon.

Medennium SmartPlug approval

Medennium Inc. received 510(k) clearance from the FDA during the meeting to market its SmartPlug. The SmartPlug is the first Medennium product approved for sale in the United States.

The “Smart” material used in the device is a thermodynamic hydrophobic acrylic polymer which, when exposed to body temperature, is transformed from a solid rod that is 9 mm long and 0.4 mm wide to a gel-like material 2 mm long and 1 mm wide within 20 seconds of being introduced into the punctum. SmartPlug is designed to eliminate the need for multiple plug sizes and minimize patient discomfort due to an exposed plug head.

Lumenis alliances, launches

Lumenis announced during the meeting that it has signed a purchase agreement to provide laser systems to Ellex Medical, an Australian-based company.

Under the terms of the agreement, Lumenis will manufacture a version of its diode-pumped solid state photocoagulator laser and grant Ellex worldwide distribution rights for a 3-year period.

According to Lumenis officials, the two companies are also working on introducing additional ophthalmic laser systems.

In a separate agreement, Lumenis also announced that the company entered into a strategic partnership with microkeratome manufacturer Moria. Lumenis will offer customers the option to purchase Moria’s microkeratomes with the Allegretto Wave excimer laser. The Allegretto Wave is manufactured by German manufacturer WaveLight Laser Technologie and is currently marketed by Lumenis outside of the United States under an international agreement.

The company also launched a number of new laser models at the meeting.

The Novus TTx is an ophthalmic 810-nm diode photocoagulator for use in transpupillary thermotherapy. It has four energy delivery modalities (normal, timed exposure, CW, and micropulse) that allow ophthalmic surgeons to control the amount of exposure released during each laser treatment. New features of the Novus TTx laser system include a distal feedback monitor, direct coupled spot size, contact lens adjustment, and a user interface touch screen.

The Novus Spectra, a 532-nm green diode-pumped solid state photocoagulation laser, recently received marketing clearance from the FDA for treatment of a variety of retinal conditions. Weighing less than 18 pounds, the system delivers up to 2.5 watts of power.

The Selecta Duet combination laser system received FDA approval for use in the treatment of open angle and angle closure glaucoma and for secondary cataracts. The Duet integrates the Lumenis patented Selective Laser Trabeculoplasty (SLT) platform with a photo - disruptor Nd:YAG.

The Novus Varia multicolor photocoagulation laser system also received marketing clearance from FDA for the treatment of age-related macular degeneration, diabetic retinopathy, diabetic macular edema, retinopathy of prematurity and retinal vein occlusions. The Varia includes green, yellow and red lasers in one platform, with the ability to switch wavelengths and change power settings on a color touch screen.

Medjet agreement with Visx

Officials at waterjet microkeratome manufacturer Medjet have extended the term of its research and development agreement with Visx by 9 months, ending July 2003.

Medjet officials said this will allow them the company to further develop its waterjet-related products. While this agreement is in effect, Medjet will continue to receive monthly payments of about $100,000 from Visx, according to Medjet.

Nidek introduces NAVEX

A new refractive laser system from Nidek recognizes existing conditions and controls spherical aberrations, according to the company.

The new Nidek Advanced Vision Excimer Laser System (NAVEX) for the Nidek EC-5000 offers comprehensive solutions for the refractive surgeon, according to Philip M. Buscemi, OD, who discussed the new system at the meeting.

OPD-Scan, Nidek’s scanning slit autorefractor, combines wavefront data with corneal topography to identify optical aberrations, Dr. Buscemi said.

In terms of aberrometry, the OPD-Scan is the only one that uses skiascopy, according to Steve Klyce, PhD, which is a time-based rather than position-based measurement technique. In terms of the OPD-Scan’s measuring principle, “it is so optically elegant it is almost frightening,” Dr. Klyce said.

The scan provides the capability of simultaneous aberrometry, topography, autorefraction and autokeratometry, making better registration for customized ablation possible. Ablation algorithms are then calculated by the company’s Final Fit software. This data is then transferred via floppy disk to the EC-5000 excimer laser.

Xalatan achieves milestone

Pharmacia Corp. announced during the meeting that Xalatan (latanoprost ophthalmic solution) achieved a major milestone, with more than 100 million prescriptions written for the glaucoma medication.

Pharmacia introduced Xalatan to the United States and Europe in 1996 and to Japan in 1999. In the United States, it is indicated for the reduction of elevated IOP in patients with open-angle glaucoma and ocular hypertension who are intolerant of other IOP-lowering medications. It is labeled as a first-line treatment for IOP reduction in open-angle glaucoma in Europe and Japan.

Intacs line expanded

Addition Technology Inc. received a CE Mark for six new sizes of Intacs prescription inserts for surgical vision correction, which doubles the company’s product line in Europe.

In response to European surgeons’ re quests, the new sizes of Intacs provide smaller increments of correction within the range of –1 to –5 D of myopia and new sizes to expand the range down to –0.5 D.

Addition Technology is currently conducting studies in Europe using Intacs inserts for the treatment of hyperopia, keratoconus and myopia with greater than 1 D of astigmatism.

Biovision microkeratome

The Visitome 20-10 microkeratome from Biovision was exhibited in the Tracey Technology booth at the meeting. The microkeratome features a disposable blade cartridge system that is manufactured using a high precision process to achieve a consistent and predictable corneal flap thickness.

The blade cartridges are provided sterile and are attached by a suction ring. According to the company, the sterile blade cartridge system minimizes the risk of complications associated with inadequate cleaning and resterilization of cutting heads and blades.

Supplement company launched

Biosyntrx, a new “nutraceutical” company, made its debut at the meeting. Founded by Spencer Thornton, MD, and other ophthalmologic, science and nutrition leaders, the company will provide research-based formulations that focus on eye and body health, including dry eye and macular degeneration.

Dr. Thornton is a clinical professor of ophthalmology at the University of Tennessee in Memphis, a past president of the American Society of Cataract and Refractive Surgery and a former member of the editorial board of Ocular Surgery News.

Carl Zeiss Meditec laser

Carl Zeiss Meditec AG unveiled its first new product since completion of its merger. The MEL 80 is an excimer laser that allows a refractive error of 5 D to be corrected in 15 seconds, facilitating faster restoration of vision, according to the company. The laser includes a high speed eyetracker that adjusts the laser beam to compensate for small eye movements.

Ulrich Krauss, president and chief executive officer of Carl Zeiss Meditec, said he hopes the new laser will help raise the company’s market share from its current 12% to between 20% and 25% within 5 years.

Alcon dietary supplement

Alcon introduced its new ICAPS AREDS Formula dietary supplement to promote healthy eyes. The product contains the same ingredients found to be beneficial to eye health in the Age Related Eye Disease Study (AREDS) sponsored by the National Eye Institute.

ICAPS AREDS feature a small tablet size and unique time release formula that make it easier to swallow and digest, according to the company.