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CRSToday Europe News – October 2008
Merger to Create Refractive Laser Company by 2009
Bausch & Lomb (Rochester, New York) and 20/10 Perfect Vision AG (Heidelberg, Germany) announced that they intend to form a joint venture—Technolas Perfect Vision—to focus solely on the laser refractive surgery market. The company is expected to be in business by the end of the year and will be headquartered in Munich, the current location of Bausch & Lomb's refractive research and development headquarters.
The partnership will merge Bausch & Lomb's refractive surgery products, including the Zyoptix Personalized Laser Vision Correction System and the Zyoptix XP microkeratome, with 20/10 Perfect Vision's Femtec femtosecond laser technology.
"The goal of the joint venture is to take products and teams from Bausch & Lomb and 20/10 Perfect Vision and place them in a new shell: a standalone, global entity focused on a complete [refractive] product portfolio," said Frieder Loesel, PhD, General Manager of 20/10 Perfect Vision AG, in an interview with CRST Europe.
"We are excited about this unique opportunity to form a global company committed to focusing on refractive laser surgery," said Kristian Hohla, PhD, current Executive President of 20/10 Perfect Vision and former Founder of Technolas, in a news release. "Combining innovative teams, visionary technologies, and state-of-the-art refractive surgery products will yield a powerful portfolio of options for customers and patients."
The new company will investigate laser-based treatments for presbyopia, including intrastromal correction, or IntraCor. The noninvasive procedure ablates stromal tissue without compromising the corneal surface. "The healing aspects are different from invasive surface and flap procedures. Because there is no incision on the surface, flap-related complications do not exist," said Mr. Loesel.
"Technolas Perfect Vision is a unique scenario," stated Mike Riding, Bausch & Lomb's Vice President of Surgical Business for Europe, Middle East, and Africa region in an interview with CRST Europe. "It is like a start-up company, but it is a start-up company that already has significant presence in the marketplace."
Two IOLs Introduced
Alcon Laboratories, Inc. (Fort Worth, Texas), announced the international release of the +3.0 Add Power AcrySof Restor Aspheric IOL and the AcrySof Phakic IOL during the 2008 European Society of Cataract and Refractive Surgeons (ESCRS) meeting in Berlin.
According to the company, at 3-month follow-up, 95% of patients who received the +3.0 Add Power AcrySof Restor Aspheric IOL achieved combined distance-corrected visual acuities (near, intermediate, and distance) of 20/40 or better. Reportedly, 96% of patients said that they would have the lens implanted again.
Clinical trials of the AcrySof Phakic reportedly improved patients' UCVA on average to better than 20/25. More than 50% of 360 patients gained one or more lines of BCVA, according to an Alcon news release. Additionally, 95% of patients said they would have the lens implanted again. Clinical follow-up showed minimal loss of central and peripheral endothelial cells. The IOL will be available in four lengths, and refractive powers will range from -6.00 to -16.50 D.
Neither IOL is currently available in the United States. Alcon filed a premarket application with the US Food and Drug Administration (FDA) in June for the +3.0 Add Power AcrySof Restor Aspheric IOL. The AcrySof Phakic IOL is currently undergoing US clinical trials.
In other news, Alcon, Inc. (HŸnenberg, Switzerland), will repurchase up to 1 million common shares from the public by December 31 to cover employee equity compensation plans, according to a company news release. Currently, the company has approximately 70 million publicly traded shares of approximately 300 million outstanding shares. Alcon's board suspended share repurchases earlier this year due to the share purchase and sale between Nestlé SA (Vevey, Switzerland) and Novartis AG (Basel, Switzerland). Neither Nestlé nor Novartis will participate in the repurchasing program, according to Alcon.
Alliance Creates Single Source For All-Laser LASIK
Schwind eye-tech-solutions GmbH (Kleinostheim, Germany) and Ziemer Ophthalmic Systems AG (Port, Switzerland) announced at ESCRS the formation of a marketing alliance. The goal of this alliance is to offer an integrated system solution for all-laser LASIK from a single source. According to a joint statement, the combination of Ziemer's Femto LDV Femtosecond Surgical Laser and Schwind's Amaris excimer laser forms an integrated surgical workstation.
A recent clinical study with follow-up for 233 and 65 eyes at 1 and 3 months, respectively, evaluated the predictability, safety, and efficiency of femto-LASIK with the Amaris/Femto LDV combination. According to the study, a mean flap thickness of 103.76 µm (standard deviation [SD], 7 µm) was achieved with the Femto LDV. Thirty-six percent of treated eyes gained one or more Snellen lines of visual acuity after 3 months. The 3-month data showed a postoperative spherical equivalent average of 0.17 D (SD, 0.22 D). Additionally, 75% of all treated eyes were within ±0.25 D of intended refraction. Ninety-four percent of eyes at 1 month and 97% of eyes at 3 months were within ±0.50 D, and 100% of eyes were within 1.00 D. Individual or personalized nomograms were used, the study noted.
Schwind and Ziemer will address international markets with their existing distribution networks. The companies' distribution partners will jointly offer package solutions to their customers. Both companies will continue to market and sell their products individually, the joint news release said.
Ellex Launches German Sales Operation
Ellex Medical Lasers Ltd. (Adelaide, Australia) launched Ellex Deutschland GmbH (Mainhausen, Germany), a direct German sales channel, at ESCRS. According to a news release, Ellex Deutschland GmbH will focus initially on sales of Ellex laser products. M+C GmbH (Mainhausen, Germany), Ellex's German distribution partner for its Eye Cubed ultrasound product, will provide administration and logistical support for the operations.
"In the past 5 years, Ellex has successfully established direct sales operations in Japan, Australia, and the United States. It is a natural step for us to establish a direct sales operation in Germany, which is one of the largest markets for ophthalmic devices in the world," Katrin Teigeler, Vice President of Marketing and Acting President of Ellex Deutschland GmbH, wrote in an e-mail to Cataract & Refractive Surgery Today Europe. "The initial response has been more than encouraging, and we look forward to expanding our operations in the coming months."
Drug-Loaded Hydrogel May Reduce Risk of Endophthalmitis
Coating an IOL with a gentamicin-loaded hydrogel may reduce the risk of endophthalmitis after cataract surgery, laboratory research suggests.
Cataract & Refractive Surgery Today Europe contacted lead investigator Carole Parsons, PhD, with the School of Pharmacy, Queen's University Belfast, for specific details about the hydrogels and the studies conducted to date. The researchers tested a range of hydrogels composed of 2-hydroxyethyl methacrylate and methacrylic acid. They examined the effects of gentamicin on in vitro bacterial adherence using a clinical isolate of Staphylococcus epidermidis obtained from a case of endophthalmitis.
"[The] incorporation of gentamicin into the hydrogels significantly reduced bacterial adherence, indicating that these antibiotic-impregnated hydrogels would be highly beneficial as IOL coatings," Dr. Parsons stated. "Further research will now ensue to inform preclinical and clinical testing."
Six-Month Results for FLEx
In a small feasibility study, researchers in Germany found that femtosecond lenticular extraction (FLEx) is an effective and safe method of refractive correction, according to a recent study in the Journal of Cataract & Refractive Surgery.1 Unlike femtosecond LASIK, FLEx does not require an excimer laser.
This prospective study included 10 eyes (10 patients) with spherical myopia between -2.00 and -8.00 D and astigmatism less than 1.00 D undergoing FLEx with the VisuMax femtosecond laser (Carl Zeiss Meditec AG, Jena, Germany). The mean patient age was 39 years. Investigators targeted a refraction of 0.75 D, and postoperative follow-up occurred at 1 day, 1 week, and 1, 3, and 6 months.
All 10 myopic eyes completed 6-month follow-up. The mean spherical equivalent was -4.73 ±1.48 (SD) preoperatively and -0.33 ±0.61 D 6 months postoperatively. Ninety percent of eyes were within ±1.00 D and 40% were within ±0.50 D of the intended correction. No eye lost two or more Snellen lines. Additionally, all patients said that they were satisfied with the results.
"The stability of FLEx is remarkable," said Walter Sekundo, MD, lead author and Professor of Ophthalmology, Gutenberg University of Mainz, Phillipps University of Marburg, in an e-mail to CRST Europe. "The procedure virtually does not increase patients' spherical aberration. Because FLEx is an intrastromal lenticule removal procedure, it opens prospects for a minimally invasive refractive correction while better preserving corneal nerves and structural stability of the cornea [compared with LASIK]."
The final results of a prospective study in more than 100 eyes were recently reported at the ESCRS meeting in Berlin. The manuscript of this larger study is currently being prepared for publication, Dr. Sekundo said.
Less PCO at 3 Years With Capsular Bending Ring
The implantation of a capsular bending ring (CBR) with an in-the-bag IOL may prevent posterior capsule opacification (PCO) and anterior capsule fibrosis, a recent study in the Journal of Cataract and Refractive Surgery reports.1
In the prospective, randomized intraindividual trial, Rupert Menapace, MD, and colleagues at the Medical University of Vienna, implanted a 0.7 mm high, open PMMA CBR (Morcher GmbH, Stuttgart, Germany) in 60 eyes (60 patients) with bilateral cataract. Researchers compared the impact of CBR implantation versus IOL implantation alone on PCO and anterior capsule fibrosis at 1, 2, and 3 years.
According to the study, no CBR-related surgical complications occurred. The objective PCO score (scale, 1–10) and area were statistically significantly reduced in the CBR group. The mean PCO score at 1, 2, and 3 years was 0.8, 1.7, and 2.1, respectively, in the CBR group and 2.6, 3.9, and 4.6, respectively, in eyes implanted with an IOL alone. The number of quadrants affected by PCO was 0.9, 1.5, and 1.8 in the CBR group versus 3.2, 3.8, and 3.8 in the non-CBR group.
Additionally, Dr. Menapace and colleagues observed fewer capsule stress folds, less fibrotic anterior capsule opacification, and better BCVA in eyes implanted with the CBR. They also found that inherent slight edge blunting and occasional eyelet gaping caused barrier failures with the CBR. Laser capsulotomies were performed only in eyes implanted without the CBR, the study said.
Benefit to Eliminating Cotton Balls During Cataract Surgery
Researchers found fibers in the anterior chamber of seven of 422 eyes (1.7%) after cataract surgery.1 During surgery, they observed fibers in five of 78 eyes (6.4%). Using microscopic and Raman spectrometric analysis, Hiroyuki Shimada, MD, PhD, and colleagues determined that the fibers were derived from cotton balls and gauze.
Eliminating the use of cotton balls during cataract surgery decreased the frequency with which fibers were found in the anterior chamber to five of 337 eyes (1.5%; P=.0239). "We recommend replacing dust-generating fibrous materials, such as cotton balls and gauze, to achieve nearly fiber-free conditions," the study authors said.
Undiagnosed RE: A Problem for Britain's Working Age Adults
Researchers in the United Kingdom recently discovered that a significant proportion of working age adults in Britain have undiagnosed but visually significant refractive error (RE), according to a report in the British Journal of Ophthalmology.1
Jugnoo S. Rahi, MD, and colleagues at the MRC Centre of Epidemiology for Child Health and the UCL Institute of Ophthalmology, investigated the frequency of visual impairment due to undiagnosed RE and its associations with vision-related quality of life (VRQOL), general health, and social circumstances among British working-age adults. This study is a part of VISION 2020, the global initiative against avoidable visual disability.
In the study, 9,271 members of the 1958 British birth cohort had visual acuity and VRQOL assessed at 44 to 45 years of age. The authors defined undiagnosed RE as greater than or equal to 0.2 logMAR units/2 lines acuity improvement in both eyes with pinhole in individuals without current or prior optical treatment or ophthalmic history.
In total, 144 (1.6%) individuals had undiagnosed and 3,513 (37.9%) had diagnosed RE. Eighteen percent of those with undiagnosed RE were classifiable as visually impaired. "Individuals with undiagnosed RE were more likely to have a manual occupation and to be separated, divorced, or widowed, and less likely to be in social or professional organizations," the researchers stated.1 Additionally, there is evidence that individuals with undiagnosed RE "are more likely to express concern, embarrassment, and frustration about their eyesight and worry about coping with life."
Working adults could avoid the adverse consequences associated with vision impairment in later life if improvements in existing programs for detecting RE in adults are made, the authors concluded.
– Compiled by Jennifer Kreatsoulas, News and Contributing Editor
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