CRSToday Europe News — September 2007

Advanced Medical Optics, Inc. Withdrew Bid for Bausch & Lomb
After several weeks of jockeying, Advanced Medical Optics, Inc. (AMO; Irvine, California) withdrew its $4.3 billion bid for Bausch & Lomb (Rochester, New York). The decision came after Bausch & Lomb refused to provide more time for AMO to prove that its shareholders would support the merger, according to a letter from President and Chief Executive Officer (CEO), Jim Mazzo.

Previously, ValueAct Capital (San Francisco), a major AMO shareholder, objected to offering Bausch & Lomb $75 per share in the form of $45 in cash and $30 in stock. Bausch & Lomb responded by asking AMO to provide "concrete credible evidence," of the acquisition's approval.

In a letter filed with the US Securities and Exchange Commission, AMO asked for more time and expressed confidence in the approval by increasing its suggested $35 million break-up fee to $50 million, if the proposal was voted down by shareholders. The company pulled out, however, after Bausch & Lomb denied the deadline extension.

In his letter to Bausch & Lomb, Mr. Mazzo called the timeline an "unrealistic hurdle" for AMO to compile "meaningful" information for the company.

AMO originally entered the 50-day go-shop process this spring, after Bausch & Lomb announced a possible merger agreement with private equity firm Warburg Pincus (New York, New York). Warburg Pincus offered the company $65 in cash per share and the assumption of the company's existing $83 million debt. Unlike the offer from AMO, this deal already had US Securities and Exchange Commission approval.

AMO used its acquisition strategy to grow its enterprise value from $410 million in 2002 to approximately $3.8 billion today.

Alcon Announced Offer for WaveLight
Alcon Laboratories, Inc., (Fort Worth, Texas) announced that it intends to acquire WaveLight Laser Technologies, AG (Erlangen, Germany) through a friendly takeover, according to an Alcon news release. Both parties have entered into a business combination agreement.

Alcon will offer ?10 per share for all issued WaveLight shares. This offer will provide a 34% premium (ie, ?7.49) on the 1-month and a 45% (ie, ?6.88) premium on the 3-month volume-weighted average stock exchange price of WaveLight shares. WaveLight's executive committee fully supported the transaction and recommended acceptance of the offer to its shareholders, subject to review of the legal documents, according the release.

"This acquisition will provide additional clinical solutions and laser technology to better support our cataract and refractive customers," said Cary Rayment, Alcon Chairmen, President, and CEO. "We look forward to welcoming the WaveLight team and believe the combination of the company's Allegretto laser with our premium lenses … in Europe enhances Alcon's product portfolio in the cataract and refractive surgeon channel."

"We are convinced that the combination of Alcon's global commercial infrastructure with WaveLight's technological capabilities will create the foundation for continued growth with the refractive surgery channel," said Max Reindl, WaveLight CEO.

Colleague Remembers Innovator, Teacher
Past European Society of Cataract and Refractive Surgeons (ESCRS) President and Board Member Michael Blumenthal, MD, passed away from complications of metastatic melanoma, in July. Dr. Blumenthal left a lasting mark in the world of ophthalmology, according to those who knew him.

Upon returning from Jerusalem to give the first Blumenthal Lecture—attended by Michael's wife, Naomi, and sons, Uli and Boaz Blumenthal—Richard Lindstrom, MD, Professor of Ophthalmology at the University of Minnesota, shared his thoughts on the ophthalmic leader's legacy in an e-mail to CRST Europe.

"I first met Michael in 1982 on a lecture trip to Israel. For the past 25 years, we have been friends and shared in traveling and teaching ophthalmology worldwide," Dr. Lindstrom wrote.

Dr. Blumenthal completed his training and residency in Israel before traveling to New York for a glaucoma fellowship. There, he was introduced to early IOL pioneers including Stephen A. Ostbaum, MD, of New York, and Norman S. Jaffe, MD, of Miami.

"This kindled his interest in cataract surgery and lens implantation. Michael did pioneering work in small-incision extracapsular cataract surgery; his mini-nuc technique is still used throughout the Third World," Dr. Lindstrom added. This cataract removal technique does not require a phacoemulsification device and may be performed through a relatively small self-sealing incision.

Dr. Lindstrom continued, "Michael also advocated for anterior chamber maintainers and helped delineate fluidics during cataract surgery, publishing a book on the topic. He did pioneering work in hydrogel lens implants, especially of an expandable nature. He was a master surgeon and traveled the world lecturing and demonstrating surgery.

"In his 30s, Michael started as a department chair at Goldschleger Eye Institute, in Tel Aviv, Israel. He then gravitated to private practice, building a large and prestigious practice in Tel Aviv. He also hosted the annual ESCRS meetings in Israel and was a member of Academia Ophthalmologica Internationalis (AOI)—a significant honor.

"Michael was a brilliant and culturally diverse renaissance man: a scientist, surgeon, and athlete. He was humorous, tolerant, easy to befriend, and a joy to spend time with. He was an extraordinary diplomat for his country. I will miss him dearly, but the lessons he taught me and hundreds of others in both ophthalmology and life, are a legacy to be proud."

CustomVue Monovision Gained FDA Approval
AMO announced that the US Food and Drug Administration (FDA) approved its Advanced CustomVue Monovision procedure as the first wavefront-guided laser vision correction procedure for myopic and presbyopic patients, with and without astigmatism, according to a company news release.

The US FDA approval is based on clinical data from a 2-year, multicenter, clinical trial of 160 patients. According to 6-month follow-up:
• 100% of patients achieved 20/40 or better vision at both distance and near;
• 100% of patients achieved binocular near UCVA of 20/40;
• 100% of patients achieved binocular distance UCVA of 20/40; and
• More than 96% of patients decreased their use of corrective lenses.

At 1 year postoperative, more than 88% of patients achieved 20/20 or better UCVA at intermediate, and 100% of patients saw 20/32 or better uncorrected intermediate vision. "[AMO] is making LASIK a viable option for the presbyopic generation," said Mr. Mazzo.

Study Found Low Retreatment Rate
A study evaluating aspheric-based treatments with the Esiris excimer laser (Schwind eye-tech-solutions, Kleinostheim, Germany) showed a high predictability of treatment results and a significant increase in visual acuity. Furthermore, there was no induction of aberrations that could reduce quality of vision or contrast sensitivity.

Maria Clara Arbelaez, MD, of Oman, and colleagues, conducted the international multicenter LASIK study of 183 eyes. The goal was to evaluate the safety, predictability, and efficacy of aspheric-based treatments with the Esiris excimer laser and the ORK-CAM software module (Schwind eye-tech-solutions). The aberration-free treatment was employed, leaving preoperative higher-order aberrations unchanged for patients to retain a habitual sight impression.

In 71% of treated eyes, the planned refractive result was achieved with a minimum deviation of ±0.25 D. Ninety-one percent were within 0.50 D, and 100% of eyes achieved 1.00 D or better. There was a significant improvement in postoperative vision without visual aids compared with preoperative vision with spectacles or contact lenses, according to the study. Additionally, 6 months after treatment, 86% of all eyes achieved a postoperative UCVA of 20/20 or better, but only 69% exhibited a BCVA of 20/20.

The study further showed that biomechanical changes of the cornea were effectively compensated with the ORK-CAM. After 6 months, no increase of significant aberrations (eg, coma, sphereical aberration) was observed, nor were additional higher-order aberrations induced, on average.

"The high-precision results were also documented through the extremely small retreatment rate (ie, greater than or equal to 2%)," said Thomas Magnago, Director of Customer Support at Schwind, in a news release.

Epi-LASIK Versus Femtosecond
A retrospective analysis of patients treated with flapless Epi-LASIK versus femtosecond LASIK showed a disparity between treatments. The study included 218 patients; one group was treated with the Moria Epi-K (Moria, Antony, France), and another group was treated with the IntraLase 60 kHz laser (IntraLase Corp., Irvine, California).

According to Michael Endl, MD, of New York, after 6 weeks, Epi-LASIK patients had better visual outcomes, more accurate results, and greater improvement in ablation profiles compared with patients treated with a femtosecond laser.

ASCRS Recommendations on Acanthamoeba Keratitis
The American Society of Cataract and Refractive Surgery (ASCRS) Infectious Disease Task Force issued a report and recommendations following the recent outbreak of Acanthamoeba keratitis and the subsequent recall of contact lens cleaning solutions. The task force recommended:

• Removing and returning any Complete MoisturePlus solutions (AMO) from offices and places of business;

• Advising all contact lens wearers of the association between the solution and the infection;

• Rubbing contact lenses with an alternative cleaning solutions and avoiding the no-rub technique advocated by manufacturers;

• Watching for early signs of the disease and using vital dyes to differentiate lesions from those caused by herpes simplex keratitis;

• Beginning moderate-to-deep stromal melting or central-to-paracentral treatment with intensive applications of topical broad-spectrum antibiotics in cases of acute keratitis (unless it is of abnormal appearance larger than 2 mm);

• Scraping the cornea for vital stains and cultures to identify the pathogen if the keratitis does not respond or has any unusual characteristics. Confocal microscopy can aid in disease diagnosis;

• Using steroids with caution in the above concerning situations, (ie, only if the organism has been identified and the patient is clinically responding to treatment);

• Diagnosing or referring the patient to a specialist early enough to improve patient outcomes; and

• Involving treatment that includes extended and frequent dosing of at least one of the cystocidal biguanides and at least one other agent (ie, neomycin, propamidine, and/or clotrimazole) for up to several months.

Additionally, the treating clinician may consider judicious use of oral itraconazole (Sporanox; Janssen Pharmaceutica, Beerse, Germany) as an adjunct to topical therapy.

Landmark Number of Devices Sold
Carl Zeiss Meditec AG (Jena, Germany) sold its 7,500th IOLMaster device, which is used as an aid for cataract diagnosis and treatment. The IOLMaster and its software have undergone continuous development, including the newly released Advanced Technology Version 5 software.

The software allows faster and more comfortable measurements that automatically calculate an accurate axial length value, even for clouded ocular media, and thereby broaden the possible patient base. The optimal measurement setting of the keratometer to the patient is signaled by an adjustment aid. IOL strength is calculated in both measurement modes; additional information is displayed for interpreting the results and calculations. The system compares both eyes' axial lengths and radii and checks their plausibility, making it easier to interpret the measurement results and allowing for specialists to confidently select the optimal lens for the patient, according to a company release.

Faulty Lenses May Cause Haze
More than 170 patients in the United Kingdom, South Africa, and elsewhere had complications after cataract surgery in relation to four different lenses. According to news and medical reports, the Aquasense lens (Ophthalmic Innovations International, Inc., Ontario, California), Hydroview lens (Bausch & Lomb), MemoryLens and MDR's SC60B-OUV lens (both manufactured by Mentor Ophthalmics, Santa Barbara, California) showed opacification after surgery. The reports indicated that the lenses may have chemically fused with their silicone packaging during shipment.

CORRECTIONS
In the Summer addition of CRST Europe (Belgium: Bladeless LASIK, New IOLs Becoming Popular, pg 70), the owner of Amadeus keratomes was listed incorrectly. The product owner is Ziemer Ophthalmic Systems AG (Port, Switzerland).

In the same article, the Zyoptix XP (with epi-LASIK head) from Bausch & Lomb, is the correct piece of epi-LASIK equipment.

We sincerely regret both errors and apologize for any confusion they may have caused.