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CRSToday Europe News — Summer
Investors, Ophthalmic Company Express Interest in Bausch & Lomb
Bausch & Lomb (Rochester, New York) reported that Warburg Pincus (New York, New York), a multinational private equity firm, could acquire the eye care company for an estimated $4.5 billion. Under the terms of agreement, Warburg Pincus would pay $65 in cash for each of Bausch & Lomb's outstanding shares, and assume an existing debt of $83 million.
According to a news release from Bausch & Lomb, the company is free to solicit superior proposals from third parties and to respond to unsolicited proposals for the next 50 calendar days (from May 16). If the company finalizes another agreement during this period, it will pay Warburg Pincus a $40 million break-up fee.
"After extensive negotiations and careful and thorough analysis, together with our independent advisors, the special committee and our board have unanimously endorsed this transaction as being in the best interest of the company and our shareholders," said William H. Waltrip, Lead Director and Chairman of the Special Committee of Bausch & Lomb's Board of Directors, in a news release.1 "We are pleased that this transaction appropriately recognizes the value of Bausch & Lomb's highly respected brand and innovative products in the eye care industry, while providing our shareholders with an immediate and substantial cash premium for their investment."
Since the initial announcement in May, Advanced Medical Optics, Inc. (Santa Ana, California) has expressed an interest in entering Bausch & Lomb's
go-shop process.
"We believe it is only logical to explore this opportunity, given the highly complementary nature of our two businesses," as stated in an Advanced Medical Optics, Inc. news release. "Consideration of this potential transaction is consistent with our existing strategy to provide a full range of products that address vision care needs of people of all ages. We believe the current transaction with Warburg Pincus undervalues Bausch & Lomb, and we plan to enter the go-shop process with the intention of exploring a superior offer for the company."
Advanced Medical Optics, Inc. gave no assurance in the release that its exploration into purchasing Bausch & Lomb will result in a transaction. The company also reported that there will be no further public comment on the issue, until it is deemed appropriate.
Lens Solution Recalled
Advanced Medical Optics, Inc. voluntarily recalled its Complete MoisturePlus contact lens solution in response to a report that linked the multipurpose cleaner to an outbreak of a rare but potentially blinding eye infection.
Since January 2005, the US Centers for Disease Control (CDC) have confirmed 138 cases of Acanthamoeba keratitis, an infection characterized by ocular pain and redness, blurred vision, sensitivity to light, foreign-body sensation, and excessive tearing. Because the parasitic amoeba causing this condition is commonly found in tap water, pools, and hot tubs, patients are being advised to remove their contact lenses before showering or swimming.
As of May, the US CDC interviewed 46 patients (39 of whom wore soft contact lenses) who were confirmed to have Acanthamoeba keratitis by microbial culture. According to the agency's Morbidity and Mortality Weekly Report, 21 of the 39 (58%) contact lens wearers stated that they used Complete MoisturePlus in the month before they developed ocular symptoms.1
Although the definitive cause of the outbreak is still unknown, factors that may have contributed to the current spike and increase in Acanthamoeba keratitis cases since 2004 include poor hygiene and improper handling of contact lenses, lower levels of chlorine in the drinking water (per a 1998 decision by the US Environmental Protection Agency), and the formulation of moisture-locking multipurpose solutions.
Advanced Medical Optics, Inc., the US Food and Drug Administration (FDA),2 and the American Academy of Ophthalmology have released statements warning patients to discontinue using Complete MoisturePlus and to discard their current contact lenses and cases until further information is available.
Report any adverse reactions from this product to the company by calling +1 800 347 5005.
Therapeutic Product Enhances Drug Absorption
Baxter Healthcare Corp. (Deerfield, Illinois) introduced hylenex recombinant, the first US FDA-approved hyaluronidase human injection, to enhance the absorption and dispersion of other injected ophthalmic drugs, according to the company.
"The incorporation of animal-derived hyaluronidase into the anesthetic protocol for ophthalmic surgery has historically been shown to increase the speed of anesthetic onset, enhance the intensity, and decrease volume of drug required," said Scott Greenbaum, MD, clinical assistant professor, Department of Ophthalmology at New York University, in a company news release.
"As a recombinant protein, hylenex represents an advanced and more sustainable supply of hyaluronidase, circumventing the quality and supply problems that have historically been associated with animal-derived product," said Gregory Frost, PhD, Vice President and Chief Scientific Officer, Halozyme Therapeutics, Inc, (San Diego) in the news release. "The use of a human protein derived from a recombinant source helps mitigate concerns over the potential for interspecies pathogen transmission and the potential for immunological reactions attributed to animal-derived products."
For more information, visit www.baxter.com.
New IOLMaster Software
Carl Zeiss Meditec, Inc. (Dublin, California), unveiled the IOLMaster software version five at the 2007 ASCRS Symposium on Cataract, IOL, and Refractive Surgery. Measurements are reportedly faster and easier with the current technology than with the earlier version. New features include improved signal processing in the axial length mode. According to Warren Hill, MD, of Mesa, Arizona, this processing "should be accurate, even in the presence of dense ocular media such as a brunescent nuclear cataract or posterior subcapsular plaque."
The system's enhanced automatic evaluative capabilities reportedly extend the spectrum of patients whose eyes were previously difficult to measure. In the keratometry mode, the IOLMaster's software features a green light to signal optimal focus and correct measurements adjustment. The system displays additional information to facilitate the interpretation of data, and it automatically calculates IOL power using internationally recognized formulas for biometry.
For more information, visit http://www.meditec.zeiss.com.
Dr. Hill is a consultant to Carl Zeiss Meditec, Inc.
Phaco System Launched by AMO
Advanced Medical Optics, Inc. launched its WhiteStar Signature phaco system with fusion fluidics during the 2007 ASCRS Symposium on Cataract, IOL, and Refractive Surgery in San Diego. According to a company news release, the system combines WhiteStar technology with the safety of a dual-pump fluidics system, and it features a streamlined user interface and easy-to-use accessories.
Fusion fluidics reportedly maintains chamber stability and reduces postocclusion surge by uniting the responsiveness of a venturi pump with the control of a peristaltic flow-based pump.
For more information, visit www.amo-inc.com.
Bausch & Lomb's Stellaris Received CE Mark
Bausch & Lomb received the Conformité-Européenne (CE) mark for its Stellaris vision enhancement system. The Stellaris system builds on Bausch & Lomb's 1.8-mm microincisional cataract surgery (MICS) platform for both biaxial and coaxial surgery. The system provides a choice in fluidics control with either a vacuum fluidics module or advanced flow module to maintain anterior chamber stability and provide surge-free phaco surgery. The system also includes enhanced energy phaco delivery with optimized power modulations for safety and efficiency, according to a company new release.
For more information on the MICS platform, visit www.MICSplatform.com.
C-Flex IOL Received FDA Approval
Rayner Intraocular Lenses, Ltd., (East Sussex, UK) received US FDA premarket approval for its C-Flex lens.
According to the company, the C-Flex injectable acrylic lenses have a unique enhanced square edge for reducing the risk of secondary cataract. "The patented antivaulting haptics provide excellent centration, no rotation, and no vaulting, which largely contributes to accurate visual outcomes," said Mark Mullaney, the Regulatory Affairs Manager at Rayner Ltd. "[The system] is also a first in that the lens is uniquely packaged with an FDA-approved single-piece
single-use injector," he added.
For more information visit, www.rayner.com.
IOL Obtains CE Mark
Medennium, Inc. (Irvine, California) announced that it obtained the CE mark for marketing Aurium, its innovative photochromic IOL. Aurium is the first and only photochromic IOL introduced in the cataract lens industry, according to the company.
"The idea for Aurium is to provide additional protection for a cataract patient's retina without any compromises, such as night vision," said Stephen Zhou, PhD, Vice President of Research and Development at Medennium, Inc. The Aurium lens responds to changes in the environment (ie, it changes yellow when exposed to sunlight and becomes colorless in an indoor environment where there is no ultraviolet or blue light). Because the lens changes colors in different light environments, there is less chance for adverse effects for night vision, according to the company.
For more information visit, www.medennium.com.
ASCRS Created International Ectasia Registry
The American Society of Cataract and Refractive Surgery (ASCRS) launched a new ectasia registry as part of a two-phase project to define ectasia, determine its frequency, and identify risk factors.
Phase one of the project is designed to gather data on ectasia after LASIK and identify physicians and patient groups for phase two, which will include prospective observational studies aimed at determining the incidence of this complication and quantifying the impact of the preoperative factors.
The ASCRS International Ectasia Registry will be housed on its own Web site at www.ectasiaregistry.com.
Knotless Suture for Fixation
A new z-shaped knotless suturing technique presented at the 2007 ASCRS Symposium on Cataract, IOL, and Refractive Surgery by Peter Szurman, MD, of Tuebingen, Germany, achieved transscleral fixation, avoided suture erosion, and minimized inflammation.1
"The main question about implants is how to fix the suture in the sclera without any visible knot," Dr. Szurman said. "We know that [some methods of suturing] are susceptible to suture erosion and other complications. Previously, techniques to bury the suture in a scleral flap were proposed to address this problem. My colleagues and I proposed a knotless technique to fix the suture."
The knotless technique uses 10–0 polypropylene sutures for the transscleral fixation of intraocular implants. During the procedure, a needle is passed through the sclera 1.3 mm from the limbus, and an intraocular implant is inserted and positioned in the sulcus. Several intrascleral passes in a zigzag formation create reliable fixation, and these sutures cannot be pulled back out of the eye. "The new flap is about four or five stitches in a simple zigzag, which can be performed in about 20 seconds," Dr. Szurman explained.
The resistance to tractive force increased with the number of stitches, according to an analog Newton (N) dynamometer. Tractive force, however, did not depend on the amplitude or angle of the stitch's insertion. The knotless suture resisted a maximum power of 0.38 N (range, 0.32-0.41 N).
The evaluation included three artificial iris diaphragms, six iris prostheses, and 15 IOLs fixed with the knotless suture. The investigators found no suture erosion, scleral necrosis, rupture, or dislocation of the implants at a mean 6.6 months follow-up.
Mini-Flared Tip for Torsional Phaco
After 2 years of performing torsional phacoemulsification, David Allen, FRCS, FRCOphth, of Sunderland, UK, presented information on a new phaco tip configuration.1 He said that the Mini-Flared Kelman tip (Alcon Laboratories, Inc., Fort Worth, Texas) maximizes the efficiency of torsional phacoemulsification by 16%. He added that it maximizes the cutting action and makes cataract removal easy.
With torsional phacoemulsification, Mr. Allen found that 22% less balanced salt solution passed through the eye during the removal of the nucleus when compared with longitudinal phacoemulsification. Retaining balanced salt solution helped to create a smoother surgery, he said. He also compared the use of three Kelman phaco tips (MicroTip, Tapered, and Mini-Flared [all manufactured by Alcon Laboratories, Inc.]). Three groups of 95 patients each underwent cataract surgery with one of the three tips, and he studied the use of phaco energy and balanced salt solution. Mr. Allen found that, in addition to the 22% decrease in the amount of balanced salt solution used, a further 16% advantage was achieved with the Mini-Flared Kelman tip. Mr. Allen noted that the MicroTip was the least efficient and the Mini-Flared tip was the most efficient.
Mr. Allen receives travel expenses from Alcon Laboratories, Inc.
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