Report from the AAO Annual Meeting
The latest clinical trial data, plus new products for your practice.
BY OPHTHALMOLOGY MANAGEMENT STAFF

Two-Year Results on Macugen Presented

Eyetech Pharmaceuticals Inc. announced that the treatment effect of its investigational drug for wet AMD, pegaptanib sodium injection (Macugen), extends for 2 years. The 2-year data presented also indicated a treatment benefit for patients who received Macugen for 2 years compared with patients who received the therapy for only 1 year.

In patients who continued therapy for 2 years, the positive effect of Macugen was statistically significant. That group, which was dosed with 0.3 mg of Macugen, experienced an approximately 45% treatment benefit compared with usual care controls (mean vision was -17.0 letters in usual care controls vs. -9.4 letters in treated eyes; p¾0.05).

In the arm of the study designed to evaluate chronic treatment, 67% more events (three lines of vision loss) were noted in patients who were limited to 1 year of therapy. This was statistically significant (21 events in the 2-year group vs. 35 events in the 1-year group; p¾0.05).

The data are from two Phase II/III randomized, multicenter double-masked studies. Initially, 1,186 patients were randomized to receive one of three doses of intravitreal Macugen or sham injection every 6 weeks for 54 weeks. Thereafter, patients were rerandomized to continue or discontinue treatment for a second year. The second year of the study included 1,053 patients.

The mean number of injections for the 2-year therapy group was 15.6 out of a possible 17, suggesting a high rate of compliance. The safety profile of the second year was similar to that of the first year; no new safety concerns were identified. Most of the adverse events were mild, transient and attributed by investigators to the injection procedure rather than the drug. Serious adverse events generally related to the injection procedure included endophthalmitis, retinal detachment, and iatrogenic traumatic cataract.

Macugen has FDA priority review status and will be addressed again at the Dec. 17 FDA meeting.

Latest Clinical, Financial Data on IntraLase Released

Daniel Durrie, M.D., presented 6-month results from his prospective, randomized study comparing visual acuity achieved by LASIK patients with an IntraLase FS-created flap with visual acuity achieved by patients whose flaps were created with a leading mechanical microkeratome.

The study followed 88 patients undergoing bilateral LASIK; one eye of each patient received an IntraLase FS-created flap, and the fellow eye received a mechanical microkeratome-created flap. Also, patients in the first arm of the study underwent wavefront-guided LASIK; patients in the second arm underwent standard LASIK.

Dr. Durrie reported that IntraLase eyes recovered vision more quickly (p<0.001), and:

► more patients with IntraLase-created flaps achieved 20/20 or better vision

► patients who stated a preference preferred the post-op vision in their IntraLase eye 3 to 1

► IntraLase-created flaps induced fewer low- and high-order aberrations

► IntraLase eyes achieved better contrast sensitivity

► visual acuity results were better in eyes that underwent standard LASIK with IntraLase flaps than they were in eyes that underwent wavefront-guided LASIK with a mechanical-microkeratome flap.

Dr. Durrie attributed the favorable IntraLase outcomes to flap architecture and consistency, and also to the dry, homogeneous surface the IntraLase leaves for the excimer laser to treat.

By the end of the third quarter of 2004, 180 IntraLase FS lasers were installed in the United States and abroad. Company executives said more than 15% of all U.S. LASIK procedures in the quarter involved a laser-created flap, a 70% higher rate than a year ago. They also reported that surgeons who use the laser increased their conversion-to-surgery rate by 20% and increased their LASIK volume by 42% compared with the industry average 16%.

	In a 10-month multicenter clinical trial, the Preview PHP showed high sensitivity and high specificity for detecting recent onset CNV and differentiating it from intermediate-stage AMD.

Carl Zeiss Meditec Launches Glaucoma, AMD Products; Plans to Acquire LDT

Carl Zeiss Meditec made three key announcements during the AAO meeting: the launch of its Preview PHP macular perimeter, the availability of SITA SWAP software for the Humphrey Field Analyzer (HFA), and the news that it will acquire Laser Diagnostic Technologies Inc., (LDT) maker of the GDx VCC glaucoma diagnostic and management instrument.

PHP. The Preview PHP is a hyperacuity perimeter designed to detect the conversion from the intermediate "dry" stage of AMD to recent onset choroidal neovascularization (CNV), before irreversible damage has occurred and before the patient is symptomatic. This capability will allow physicians to intervene earlier with treatment. Yair Alster, M.D., who developed the instrument, says that eight out of 10 patients who develop CNV can be detected earlier with the PHP than they can be today, and "Early detection is the single most important factor in final visual outcome." The Preview PHP is expected to dramatically improve the correctness of referrals to retina specialists, but Dr. Alster also sees a place for it in the specialist's office, as a tool for measuring macular function outside the fovea and determining the effect of treatments on the entire macula.

Results of a 10-month clinical trial conducted at four U.S. centers and three centers in Europe were present at the AAO meeting. The results showed that the instrument has high sensitivity and high specificity for detecting recent onset CNV and differentiating it from intermediate AMD.

The company is working with CMS to determine how reimbursement for testing with the Preview PHP instrument might be structured.

SITA SWAP. The company says the availability of the SITA SWAP software is another step in the continual evolution of the HFA. Short-wavelength automated perimetry assesses the short-wavelength-sensitive color system. The SITA upgrade reduces test time to 4 to 6 minutes, one third of what it was previously, and decreases variability between test results.

Studies have shown that SWAP picks up deficits 3 to 5 years before standard achromatic perimetry. Additionally, SWAP deficits are predictive of the onset of future visual field loss, and the upgrade improves the technology's ability to identify progression.

SITA SWAP is now available as an upgrade to HFA models 745, 745i, 750, 750i, and is included on all new 745i and 750i instruments.

Acquisition. Carl Zeiss Meditec's acquisition of LDT is expected to be finalized in December. In the next few months, LDT manufacturing operations will be relocated to the Zeiss Dublin, Calif., facility.

LDT's GDxVCC is a dedicated glaucoma diagnostic and management tool, which Carl Zeiss Meditec says is a complement to its Stratus OCT, a multipurpose retinal imaging system used not only in glaucoma but also in an array of conditions including AMD and diabetic retinopathy. Therefore, the company says, the GDxVCC is well-suited for practices that don't require the full range of capabilities offered by the Stratus OCT. Carl Zeiss Meditec says the acquisition gives it the most comprehensive line of both structural and functional assessment tools for the management and treatment of glaucoma.

Preliminary TTT4CNV Data Released

Preliminary 2-year results from the TTT4CNV clinical trial show that patients treated with the Iridex Transpupillary Thermotherapy (TTT) laser protocol didn't derive any significant benefit compared with patients who were given sham treatment.

Elias Reichel, M.D., associate professor of ophthalmology at the New England Eye Center, Tufts University School of Medicine, who chaired the 303-patient study, reported that at 2 years, 47% of eyes treated with TTT avoided modest or severe vision loss, compared with 43% of eyes that received sham treatment, which was not considered statistically significant.

It was also reported that 11% of patients who were treated with TTT showed vision improvement of 2 lines or greater after 1 year, compared with 3% of patients who showed similar improvement after the sham treatment. This secondary outcome is considered statistically significant.

"Further analysis of this subgroup of patients with improved vision may yield information regarding those patients who respond to TTT," said Dr. Reichel. "Specifically, this subgroup of patients may have certain characteristics that result in a high likelihood of improvement or stabilization over time."

In all TTT-treated eyes, laser energy was applied at 800 mW with a 3-mm spot size for 60 seconds with the Iris Medical OcuLight SLx 810 nm laser and large spot slit-lamp adapter. One retreatment was permitted at 3 months during the follow-up period at the physician's discretion.

TTT treatment has already been approved for Medicare reimbursement in 17 states. Kari Lemiere, global marketing manager for Iridex, says it's not yet known if this trial will affect reimbursement for the procedure.

"It is too early to tell at this point," says Lemiere. "The TTT4CNV trial results presented (at the AAO meeting) were preliminary since they only had 3 weeks to analyze trial data. We expect more information to come out after they have time to review subgroups. TTT reimbursement remains at the discretion of local Medicare carriers."

Lemiere says most of the Medicare carriers that don't currently reimburse for TTT have indicated that they will review TTT4CNV clinical data once a peer-reviewed paper has been published and make a coverage determination at that point.

Investors showed their disappointment with the trial results as Iridex stock fell more than 35% to $4.50 a share on the day that the study data was announced.

Further Analysis of Retaane Trial Results Under Way

Alcon reported that results from its Phase III trial (C-01-99) comparing anecortave acetate for depot suspension (Retaane 15 mg) with Visudyne indicated the two therapies are not statistically different from each other.

In the Retaane group, 45% of patients lost fewer than three lines of vision; in the Visudyne group, 49% of patients lost fewer than three lines of vision (per protocol p = 0.43), meaning there was no statistical difference between the two groups, but the primary noninferiority endpoint outlined in the protocol was not met.

The initial analysis of the data, which was presented at the AAO meeting, indicated three possible reasons for the results: reflux, treatment interval, and lesion characteristics:

Reflux. Reflux can occur when a portion of the drug leaks out through the small incision in the conjunctiva during or immediately after application. Data on reflux were collected prospectively. To prevent reflux, a counter-pressure device is now being used in every Retaane clinical trial. The device (see image on next page) is held perpendicular to the eye, posterior to and straddling the juxtascleral delivery cannula, for 5 seconds after the cannula is removed. A 2-week study to demonstrate control of reflux with the counter-pressure device began enrolling in October, with a goal of approximately 30 patients. Completion of that study is not a prerequisite to Alcon submitting the final data module -- the last portion of the New Drug Application (NDA) -- to the FDA.

Treatment interval. Data on treatment interval also was collected prospectively. Results for Retaane were more favorable when treatment was administered within 6 months of the previous treatment. "The molecule works when it's where it's supposed to be when it's supposed to be there," one investigator said.

In cases where no reflux occurred and treatment was administered within 6 months, 57% of the Retaane patients lost fewer than three lines of vision compared with 49% of the Visudyne patients (per protocol p=0.193).

Lesion characteristics. The lesions in the study were found to be very small, young and active. Investigators attributed that to the fact that all of the patients met the inclusion criteria, which included no previous treatment and predominantly classic lesions, ensuring that the lesions were new and fast-growing. For example, the median age (from diagnosis) of lesions in C-01-99 was 37 days, and the median age of lesions in another Retaane trial C-98-03 was 270 days. Also, mean total lesion size in C-01-99 was 3.7 mm2 compared with 8.0 mm2 in C-98-03.

Patients in the C-01-99 study were treated every 6 months with Retaane and every 3 months with Visudyne if leakage occurred (per PDT guidelines). Safety results from the study show Retaane "continues to be remarkably safe," said safety chairman Donald D'Amico, M.D.

Data analysis will continue, and Alcon is proceeding with its plan to file the NDA with the FDA by the end of this year. The NDA will incorporate the 12-month results from this study along with results from other clinical studies completed during the development program.

The counter-pressure device for controlling reflux is now being used in all anecortave acetate (Retaane) clinical trials.

Cyclosporine Studies Examine Long-Term Use and Use in Rosacea

In a study conducted by John Wittpenn, M.D., et al., Ophthalmic Consultants of Long Island, Stony Brook, N.Y., cyclosporine 0.05% (Restasis) effectively treated the signs and symptoms of active, chronic ocular rosacea in patients who had failed to respond to traditional treatments. A retrospective chart review identified 55 patients with chronic ocular rosacea refractory to traditional treatments who were subsequently treated with Restasis. Ages ranged from 30 to 78; 51% were male; 49% were female. At the time of the review, the patients had undergone a traditional treatment regimen (warm soaks, lid hygiene, oral tetracyclines, topical antibiotics, short courses of topical corticosteroids) for 1 to 2 weeks and then treatment with Restasis for 2 to 11 months (average 5.2 months).

Based on patient assessment and clinical examination, including supravital staining:

► 46% of patients (25 of 55) showed significant improvement or complete resolution

► 38% of patients (21 of 55) showed mild-to-moderate improvement

► Nine patients withdrew from the study. Five complained of burning, itching or tearing; four failed to improve

► At last follow-up, 39% of patients (18 of 46) required no medications in addition to Restasis; 61% (28 of 46) continued low-dose tetracyclines along with Restasis; two patients also continued topical steroids q.d.

The researchers said further research should evaluate Restasis as a first-line therapy for ocular rosacea.

Also at the AAO meeting, Laurie Barber, M.D., professor of ophthalmology at the University of Arkansas Medical School, et al. presented the results of their Phase III extension study, which evaluated the safety of cyclosporine 0.1% used for up to 4 years to treat dry eye. The multicenter, nonrandomized, open-label study included 412 patients who had participated in one of two previous studies during which they were dosed with cyclosporine 0.05% (the commercial concentration of Restasis) or 0.1% for 6 to 12 months. In the extension study, they were dosed with Restasis 0.1% b.i.d. for 12 to 36 months.

Based on corneal staining, Schirmer tests, symptom severity assessments and other subjective measures, the researchers concluded that long-term dry eye therapy with Restasis 0.1% is safe and well-tolerated and not associated with systemic side-effects.

Millennium Phaco System Undergoes Enhancements

Bausch & Lomb announced the availability of two enhancements to its Millennium microsurgical phacoemulsification platform:

► Custom Control Software (CCS) combines the benefits of a lower frequency phaco tip with hyperpulse power modulation for what the company calls "hyper-cool" phaco energy delivery. A range of programmable settings supports a variety of surgical techniques from standard to bimanual. The software's hyperpulse technology (0 to 120 pps) has an adjustable duty cycle that ranges from 10% to 90%, providing precision control and cutting efficiency while limiting heat formation. B&L says a unique waveform phaco modulation technology improves balance and coordination between irrigation, aspiration and ultrasound pulses, which further reduces the amount of energy delivered into the eye.

► The Millennium Advanced Flow System (AFS), designed for use with CCS, is a peristaltic system that offers a selectable range of flow-based efficiency settings that increase responsiveness to vacuum-based performance while maintaining fluidic stability. The company says that in combination with the Millennium's Dual Linear technology, AFS gives surgeons precise and simultaneous control of vacuum limit, or flow rate and phaco power for unsurpassed intraoperative control.

VISX Expects Several Wavefront-Related FDA Approvals Soon

FDA approval of the VISX automatic iris registration technology was expected within weeks of the AAO meeting. The technology compensates for eye cyclotorsion that occurs when a LASIK patient goes from the WaveScan unit (upright) to the laser (supine). It calculates torsional angles from multiple measurements and reference points on the iris captured by the WaveScan aberrometer so the iris can be registered at the laser for treatment. In a study involving 69 eyes, Julian Stevens, FRCS, was able to capture more than 95% with iris registration, and he has assessed and treated patients where torsional error of up to 8 degrees has occurred.

Additionally, this technology automates the pupil centration process by compensating for pupil centroid shift as patients move from the WaveScan aberrometer to the laser, which is accomplished by using the outer boundary of the iris as a fixed landmark. Until now, manual adjustments and strict control of lighting conditions were used to compensate for any change in pupil centration.

The company has completed its FDA multicenter clinical trial of wavefront-guided treatment for hyperopic astigmatism. The range of treatment in the trial is up to +5D of sphere and +4D of cylinder. Nine-month data have been submitted to the FDA. Approval is possible this quarter.

VISX is also conducting an FDA multicenter trial of its wavefront-guided treatment for high myopia. The range of error being treated is up to -11D of myopia and up to -5D of astigmatism. At 6 months, 55% of the 184 eyes have achieved 20/16 UCVA and 76% have achieved 20/20 UCVA. Approval for the high-myopia application could come during the first half of 2005. An additional FDA trial, of the company's wavefront-guided treatment for hyperopic presbyopia, has begun. In the international trials, at 12 months of follow-up, 80% of patients achieved, simultaneously, 20/25 or better distance UCVA and J3 near vision.

The company also reported that Fourier Wavefront ablations are now FDA approved and the capability is now installed in most U.S. practices using the VISX platform.

Surgeon Imparts Advice for Using Healon5 Effectively

In a presentation at the Advanced Medical Optics booth, Robert Osher, M.D., Cincinnati, Ohio, explained why Healon5 is his viscoelastic of choice for cataract surgery. He offered pearls for each step of the procedure, including:

Capsulorhexis. Rather than using a soft-shell technique or partially filling the chamber, Dr. Osher fills the entire chamber with Healon5. With that approach, he finds that the capsulorhexis has no tendency to "run" peripherally. Also, the stability allows him to create a precise capsulorhexis in any size or shape.

Hydrodissection/hydrodelineation. During this step, Dr. Osher lets the viscoelastic "belch out" by depressing the lower lip of the incision with the cannula. This prevents an extremely deep chamber with zonular stress. "I want the Healon5 to escape because it is diluted and fractured at this point," he says. Prior to phaco, he injects fresh Healon5.

Phaco. Dr. Osher is able to keep the Healon5 in the anterior chamber during the entire phaco by working below it within the capsular bag.

Cortical removal. Cortex under Healon5 can be removed by keeping the port occluded with cortical material and avoiding engagement of the viscoelastic material.

IOL implantation. Dr. Osher said he has not found the viscosity of Healon5 to interfere with IOL implantation. Rather, he says, "It's reassuring that the Healon5 cushions the unfolding of a silicone IOL and gently maintains the small profile of an acrylic lens while expanding the capsular bag."

He also reported during his presentation that he and colleagues have now used Healon5 in approximately 15 cataract surgeries in patients with Fuch's Dystrophy and endothelial cell counts of less than 200. He said that most have achieved uncorrected visual acuity of 20/40 or better on the first day after surgery.

Physicians Honored as Visionaries

As part of its 150th anniversary celebration, Bausch & Lomb honored the achievements of four ophthalmologists with the 2004 Bausch & Lomb Visionaries Recognition Award: Eleanor Faye, M.D., Lighthouse International, New York Bradley Staatsma, M.D., Jules Stein Eye Institute, Los Angeles Michael Trese, Associated Retinal Consultants, Royal Oak, Mich. George Waring III, M.D., Atlanta. "The 2004 visionaries are outstanding professionals who have made significant contributions to the field of eye health," said B&L Senior Vice President and President of the Americas Region Paul G. Howes. They were nominated by their peers and selected by an independent committee of representatives from academia and professional organizations. B&L will equally distribute a total of $150,000 among vision-related nonprofit organizations chosen by these four physicians as well as Karla Zadnik, O.D., Ph.D., who was honored as a visionary in June. Left to right: Michael Trese, M.D., Eleanor Faye, M.D., George Waring II, M.D., Bradley Staatsma, M.D., Ronald Zarrella, Bausch & Lomb chairman and CEO.

Phase III Trials Show Benefits to Photrex PDT for AMD

Miravant Medical Technologies, a pharmaceutical development company specializing in PhotoPoint photodynamic therapy (PDT), said results from analyses of two rostaporfin, SnET2 (Photrex) Phase III clinical trials, showed that Photrex treatment resulted in significant benefits for many patients.

Photrex is a proprietary PDT drug in development for the treatment of wet AMD. Based on data from the randomized, placebo controlled 2-year trials, clinical investigators reported:

► significant visual acuity (VA) benefits in Photrex-treated (0.5mg/kg) patients with occult choroidal neovascularization (CNV) lesions

► angiographic evidence that Photrex treatments slowed the progression of both classic and occult CNV leakage and fluid accumulation

► treatment benefit in Photrex patients regardless of visual acuities at commencement of treatment, with a greater benefit noted with higher baseline VA.

The trials were conducted at 60 U.S. ophthalmology centers. The primary efficacy endpoint for the 2-year studies was the percentage of patients losing less than 15 letters (3 lines) of vision on a standard eye chart. Pooled results from the two studies, totaling 450 patients, demonstrated that 58% of patients receiving Photrex met the efficacy endpoint compared with 42% of those receiving placebo treatment.

Edgar L. Thomas, M.D., of Retina-Vitreous Associates, Los Angeles, presented favorable visual acuity results based on subgroup analyses of lesions with predominantly (greater than or equal to 50%) occult CNV, including pure occult lesions. Statistically significant vision benefits were observed in occult CNV lesions treated per protocol. Currently there are no FDA-approved therapies for occult CNV lesions.

Miravant says the occult VA outcomes were supported by secondary angiographic assessments reported by Ronald P. Danis, M.D., University of Wisconsin Fundus Photograph Reading Center, Madison, Wisc. Photrex-treated lesions (both classic and occult CNV) had statistically significant reductions in vessel leakage and fluid accumulation, factors that are considered to be indicative of AMD disease activity.

Baruch Kuppermann, M.D., Ph.D., University of California, Irvine, presented data on the effect of baseline visual acuity on efficacy at the study endpoint. Analysis of results showed a statistically significant treatment benefit for all baseline VA strata. The greatest relative gain over placebo was noted in patients at highest risk of vision loss, i.e., those with higher VA at the commencement of treatment. Irrespective of baseline VA, patients receiving placebo were approximately 2 times more likely to lose 3 or more lines of vision than treated patients.

Miravant also said it had received an FDA approvable letter for Photrex, which included a request for a confirmatory clinical trial.

FDA Approves CK-After-LASIK Trial

The FDA has granted Refractec Inc. approval to begin a Phase III clinical trial to study the possible benefits of NearVision Conductive Keratoplasty (CK) in patients who previously had LASIK surgery.

According to Refractec, approximately 4.8 million people in the United States have undergone LASIK since 1997. Refractec says that at a current average age of 42, nearly 44% of those who've had LASIK are now presbyopic and facing the possibility of having to wear eyeglasses again.

"Unfortunately, presbyopia is an equal-opportunity eye condition. The eye continues to age, whether you've had LASIK or not, and with age comes an inevitable decrease in near vision," says Daniel S. Durrie, M.D., associate clinical professor, University of Kansas.

Data from a pilot study of NearVision CK on 29 post-LASIK eyes was used in support of the clinical trial application. Those results showed:

► no adverse events or complications

► postoperative uncorrected visual acuity at 1-month- and 3-month follow-up showed 72% of patients achieved J2 reading vision or better

► no compromise to LASIK flap integrity.

Minimally invasive CK is now being widely used to correct presbyopia and has become the nation's leading nonlaser refractive procedure, according to data published by the research firm Market Scope. NearVision CK is indicated for the temporary improvement of near vision in emmetropic and hyperopic presbyopes, and is typically performed in just one eye.

FDA OKs HRTII Cornea Module

Heidelberg Engineering has received FDA clearance for its Rostock Cornea Module, a key component for the company's new confocal laser microscope. Heidelberg says ophthalmologists will be able to use the microscope to image and measure corneal structures and diseases that were previously difficult, or even impossible, to see.

The Heidelberg product is the first FDA-cleared microscope that uses laser-scanning technology to directly image a patient's cornea. The new product displays magnified images of the internal structures of the cornea, enabling the clinician to directly view the cell layers and individual cells in real time. The module connects directly to the HRTII, Heidelberg's widely used laser-imaging instrument for glaucoma.

"We expect availability of this instrument to alter practice patterns for refractive laser surgery, cataract and implantable contact lens surgery, and general eyecare diagnostics," says Travis Lindsay, Heidelberg's chief operating officer. Heidelberg says the microscope may also prove important for recognizing the parasitic infections that often affect long-term contact lens wearers.

Eyeglasses to be Based on Patients' Wavefront Measurements

Ophthonix is about to introduce eyeglasses that are matched to what the company calls a patient's individual "optic fingerprint."

Ophthonix says its proprietary system translates a patient's wavefront map, captured at a physician's practice, into a customized prescription, which is then used to manufacture, in another location, what it calls the Z-Lens. According to the company, the prescription is programmed into the polymer lens material much like a compact disc is programmed, with no grinding or molding required.

Key to the entire process is Ophthonix's Z-View Aberrometer, which measures low- and high-order refractive errors that enable the prescription to correct for not only myopia or hyperopia, but also halos, fuzziness, shadows and other errors that interfere with visual acuity. Ophthonix says the result is excellent acuity, better contrast, minimal glare or distortion and high color perception. The Z-View Aberrometer is already available to eyecare providers at a cost of approximately $28,000.

Ophthonix, which is headquartered in San Diego, says its new type of vision correction will be available to consumers in eyeglasses by year-end, and in contact lenses sometime in 2005. Pricing is expected to be at about a 25% premium to a fully loaded, conventional high-index lens.

Canon Introduces New Camera, Image and Data Management System

Canon U.S.A. introduced the CF-60DSi all-digital color fundus camera, which offers PC-based operation and image management. Color imaging and fluorescein angiography are both performed with the attached EOS Digital SLR camera. An optional camera unit is available for adding ICG angiography capability. The instrument's optics provide a 60-degree viewing angle. Canon says its high-resolution CMOS sensor delivers unsurpassed detail and contrast, even when you enlarge part of an image for a closer look. The sensitivity of the sensor also reduces the amount of light needed for image capture, making the process more comfortable for patients. The CF-60SDi's DICOM-compliant network interface allows for connection to a variety of network configurations, including local-area and wide-area networks. Depending on configuration, the CF-60DSi ranges in cost from $60,000 to $85,000.

Canon also introduced Eye Q Prime software, its new imaging and data informatics solution. Eye Q Prime runs on Canon's intelligent Platform (iP), which is based on the Microsoft.NET framework. Canon says it allows for the creation of robust and secure applications that can manage complex processes such a patient workflow. Eye Q is customizable and scalable to a practice's needs. Modules include image view and annotations service, clinical follow-up and referral services, image anatomy and grading services, and clinical outcome management service. When used with the company's Nonmydriatic/Mydriatic Fundus Camera, the system captures high-resolution digital images that can be reviewed, analyzed, printed and digitally communicated to any medical station, home office or satellite office in the world. Canon cites these efficiency and cost-control benefits: adaptability to the unique workflow of any practice, facilitation of efficient diagnosis and treatment, streamlining of large screening programs, patient data management, interfacing with various instruments, data import and mining, and the triggering of events based on observations and outcomes. Depending on configuration, the Eye Q Prime software and Nonmydriatic/Mydriatic Fundus Camera ranges in cost from $25,000 to $100,000.

Study Assesses Fluoroquinolones' Effect on Wound Healing after PRK

In a double-masked study, Renée Solomon, M.D., Eric Donnenfeld, M.D., et al. evaluated the effects of gatifloxacin 0.3% (Zymar) and moxifloxacin 0.5% (Vigamox) on epithelial wound healing in PRK patients, concluding that Vigamox delays healing compared with Zymar.

Twenty-two patients who were undergoing PRK were randomized to receive prophylactic Zymar or Vigamox 1 hour preoperatively and immediately prior to surgery. Postoperatively, patients were dosed q.i.d. for 1 week with Zymar or Vigamox. Epithelial defect was measured with a slit lamp caliper and digital photography. Photos of the defects were taken daily, and the size of the defects was recorded after surgery and daily until the defects healed.

The researchers reported that mean epithelial closure time for the Zymar-treated eyes was 3.8 ±0.61 days, with a range of 3 to 5 days. Mean epithelial closure time in the Vigamox-treated eyes was 4.7 ±1.21 days, with a range of 3 to 7 days (p=0.002).

	In October, the Allegretto Wave had achieved a 20% share of all new U.S. refractive laser sales for the prior 12 months.

Study Assesses Fluoroquinolones' Effect on Rabbit Epithelium

Scientists in the Department of Ophthalmology at the University of Texas Southwestern assessed the effects of short-term exposure to moxifloxacin (Vigamox) and gatifloxacin (Zymar) on the corneal epithelial surface in 18 rabbits using in vivo confocal microscopy and in 10 rabbits using ZO-1 staining. They concluded that corneal epithelial integrity and tight junction organization are maintained after short-term exposure to Vigamox, and that in this rabbit model Zymar induces damage to the corneal epithelium as indicated by a quantitative reduction in surface cell size and loss of normal ZO-1 staining.

Baseline confocal exams were performed on the rabbits. Two weeks later, six eyes were bathed with Vigamox for 3 minutes and then rinsed with balanced salt solution (BSS), and six eyes were bathed in Zymar for three minutes and rinsed with BSS. In six rabbits, BSS rinsing only was used as a control. Immediately after treatment, corneas were examined using in vivo confocal microscopy.

In the control and Vigamox groups, superficial epithelial cells looked similar to baseline images, having visible cell borders and bright nuclei. The surface cells in eyes treated with Zymar appeared smaller, brighter, and had less distinct borders. Quantitative analysis demonstrated a significant decrease in epithelial cell area after treatment with Zymar (p<0.05), but not Vigamox or control. The researchers said the decrease in cell size suggests a loss of some superficial epithelial cells, which leads to exposure of the smaller wing cells on the ocular surface.

In the ZO-1 labeling part of the study, one eye of five rabbits was bathed with Vigamox for 3 minutes and rinsed with BSS, and one eye of five rabbits was bathed in Zymar for 3 minutes and rinsed. The contralateral eyes served as controls with BSS rinse only. After the rabbits were sacrificed, the corneas were fixed and stained with rat monoclonal anti-ZO-1 and imaged with laser confocal microscopy. In the control and Vigamox groups, ZO-1 was organized in a continuous linear pattern along the cell-to-cell junctions. Staining in the Zymar eyes showed regions of dropout, which the researchers said suggests a loss of superficial calls. Other regions showed ZO-1 staining along coil junctions, but labeling was generally weaker than in the control and Vigamox groups.

WaveLight Inc. Reaches Sales Milestone

Wavelight Inc. reported that according to independent market research company Market Scope, the Allegretto Wave excimer laser had achieved a 20% share of all new refractive laser sales in the U.S. in the 12 months prior to October. Internationally, WaveLight has an installed base of 411 Allegretto Wave lasers.

"We consider our success in the U.S. market to be out greatest accomplishment to date," said Max Reindl, CEO of WaveLight Laser Technologie, AG. "Ophthalmologists and patients alike benefit from the Allegretto Wave's shorter treatment times, safety features and unique ablation profile designed to minimize the induction of spherical aberrations during surgery. Strong demand for the Allegretto Wave validates our commitment to develop and introduce the most innovative technology in the marketplace."

Also during the AAO meeting, WaveLight presented three ophthalmologists with Accento Awards to acknowledge their leadership toward the advancement of new refractive laser technology: Amar Atwal, M.D., Buffalo, N.Y.; Avery Alexander, M.D., Appleton, Wisc.; and Michael Gordon, M.D., San Diego, Calif.

Charles Moore, M.D., received WaveLight's Global Ambassador Award for his role in the laser's FDA trials and as an educator and expert reference for new users.

ISTA Gives Status Report on Three Medications

ISTA Pharmaceuticals provided a status report on three of its medications:

► In one of two Phase III, double-masked, placebo-controlled studies that used a single protocol, 64% of patients treated with ISTA's investigational drug bromfenac sodium ophthalmic solution (Xibrom) achieved a summed ocular inflammation score (SOIS) of zero compared with 43% of patients receiving placebo. The company is seeking approval of Xibrom, a topical nonsteroidal anti-inflammatory drug (NSAID), for treating ocular inflammation, eye pain, and photophobia. It says Xibrom would be the first NSAID with b.i.d. dosing. FDA approval is possible early next year.

► The FDA has determined that ISTA's timolol maleate 0.5% (Istalol) glaucoma medication isn't therapeutically equivalent to other commercially available timolol maleate solutions and has granted Istalol a "BT" rating. This means that prescriptions for Istalol can't be substituted legally at pharmacies with generic products. ISTA has launched an extensive campaign to notify retail pharmacists of the FDA's granting of the "BT" rating.

► Ovine hyaluronidase (Vitrase) had previously been approved by the FDA as a spreading agent. For now, the approval covers a 6,200 unit/ml vial, but the company submitted a supplemental NDA in August for a 150 unit/ml vial, and hopes to receive that approval by the end of this year. ISTA is also seeking approval of Vitrase as a treatment for vitreous hemorrhage. The company has received an approvable letter; however, the FDA requested additional analysis of the data and an additional confirmatory clinical study based upon that analysis. Work toward full approval continues.

Allergan Celebrates "55 Years of Innovation"

Allergan executives, including Joseph Schultz, who was recently named senior vice president of the company's U.S. Ophthalmology business unit, provided members of the media with a profile of the company -- past, present and future. Allergan was founded in 1950 as a one-product company above a pharmacy in Los Angeles. By 2003, it had achieved a global presence with sales of $1.7 billion. It was ranked number one in global growth in ophthalmics by pharmaceutical market research company IMS for 2004.

The company attributes its current position to its history of responding to marketplace demands and investing in research and development. "Throughout Allergan's history, our philosophy has been that product innovation is directly dependent on our responsiveness to the needs of our customers," said Julian Gangolli, president, U.S. Pharmaceuticals. The company said it invested approximately 18% of sales into research and development in 2004. More than 1,000 of its approximately 5,000 employees are focused on R&D.

The company has several ocular medications in Phase III clinical trials or awaiting FDA approval, including Memantine, a Lumigan/Timolol combination, an Alphagan/Timolol comination, and a new formulation of Alphagan for glaucoma; Posurdex for macular edema; and diquafosol for dry eye.

RetCam II Technology Applied to Anterior Segment

Massie Laboratories has used the technology behind its RetCam II digital pediatric retinal imaging system to create the ADIS-9000, a new anterior segment and fundus imaging device for adult patients.

With the ADIS-9000, clinicians can capture panoramic images of anterior-chamber pathologies, including primary open-angle glaucoma. According to Massie, the ADIS-9000 offers high-resolution, handheld versatility. It records and replays digital video of examination segments for dynamic documentation, and according to the company, is the only integrated device offering both high-resolution digital still or full-resolution digital video imaging options. Like RetCam II, the ADIS-9000 takes digital images of the eye while patients are reclining, providing a more comfortable and less arduous experience, using lower illumination than the traditional photo slit lamp and contact gonioscopy lens method. The imager head floats on topical gel that is both a cushion and optical coupler for sharp clear visualization.

"Existing photography technology of this very discreet area of the eye takes many years to master and requires a great deal of skill and practice," said Bert Massie, M.D., founder, chairman and chief executive officer of Massie Labs. "With its digital imaging capability and its ease-of-use, the ADIS-9000 provides superior images, and offers convenience to practitioners and maximum comfort for their patients."

Alcon Introducing Automatic Registration for CustomCornea Platform

Alcon is currently upgrading existing LADARWave units with the capability to automatically register wavefront measurements during capture. The upgrade eliminates several previously required steps to capturing wavefront measurements. By using new imaging software, the LADARWave aberrometer now automatically detects the unmoving landmarks of the eye, positioning limbal rings based on them. The company says automatic registration greatly reduces human error in the wavefront capture process and eliminates variabilility between technicians, enhancing outcomes and saving time.

This upgrade further enhances the previously integrated CustomCornea Surgery Planning Software, which provides ablation depth profiling, treatment offset capability, nomogram management, faster auto-fogging, and treatment planning summaries.