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CRSToday Europe News – October 2009
Abbott To Gain Accommodating IOL in Visiogen Acquisition
Abbott (Abbott Park, Illinois) announced on September 2 a definitive agreement to acquire Visiogen, Inc. (Irvine, California), for $400 million in cash. The acquisition will provide Abbott with Visiogen's Synchrony accommodating IOL, which is currently under review by the US Food and Drug Administration (FDA). The lens received the Conformité Européene (CE) mark and has been available commercially in Europe since January 2009.
The Synchrony is designed to deliver improved vision at near, intermediate, and distance, potentially eliminating the need for glasses or contact lenses, reducing glare and nighttime halos, and improving contrast sensitivity, according to Visiogen company literature.
"We are thrilled to join forces with Abbott to bring this much-anticipated technology to market," said Reza Zadno, Founder, President, and Chief Executive Officer of Visiogen, in an article in Medical Device Daily.1 "The global clinical results with Synchrony are extremely encouraging, and the opportunity to leverage Abbott Medical Optics' extensive commercialization infrastructure means that more patients will benefit from this exciting advancement in cataract and presbyopia correction."
In an interview with Cataract & Refractive Surgery Today Europe, James Mazzo, President of Abbott Medical Optics Inc. (AMO; Santa Ana, California) said the deal is expected to close in the fourth quarter of this year and will better help Abbott compete in the premium IOL category. "I think the practitioners and their patients are ready for accommodating IOLs. Bausch & Lomb's Crystalens [Rochester, New York] has had great success, as well as multifocals from AMO and Alcon [Alcon Laboratories, Inc., Fort Worth, Texas], and I think the [multifocal] space is going to continue to grow [because these lenses] are meeting—and in some cases exceeding—the needs of patients," Mr. Mazzo said.
Visiogen possesses additional technologies in its pipeline that Mr. Mazzo said add to the attractiveness of the deal. AMO plans to launch an accommodating IOL within the next 5 years that will "complement the Synchrony," Mr. Mazzo commented. Details about AMO's future accommodating IOL are not available to the public at this time. FDA approval of the Synchrony is anticipated for the latter half of 2010.
Alcon Acquires Swiss Biotechnology Firm
Alcon, Inc. (Huenenberg, Switzerland), has agreed to purchase Swiss biotechnology developer ESBATech AG (Zurich, Switzerland), for $150 million. According to a news release, Alcon will also "be responsible for contingent payments of up to $439 million based on the achievement of future research and development milestones that would be expected to create value for [the buyer]."1
Under the terms of the agreement, Alcon acquires the rights to ESBATech's proprietary single-chain antibody fragment technology. Phase 1 and 2 clinical trials of experimental agents suggest that this therapeutic platform may enhance the treatment of age-related macular degeneration, diabetic macular edema, glaucoma, dry eye, and uveitis by facilitating the topical and local delivery of therapeutic agents.
A news release from the companies states that the ESBATech's previous shareholders will retain the rights to nonophthalmic products and applications under the auspices of the new company Delenex Therapeutics AG.
FEMTOSECOND TECHNOLOGY FOR ANTERIOR CAPSULOTOMY
The FDA has cleared the LenSx femtosecond laser (LenSx Lasers, Inc., Aliso Viejo, California) for anterior capsulotomy during cataract surgery in the United States.
In an unpublished clinical trial, Zoltan Nagy, MD, found that the LenSx predictably and reliably created perfectly circular, smooth-edged capsulorrhexes, according to the manufacturer.
Additionally, significantly more capsulorrhexes created with the femtosecond laser (100%) versus manual methods (10%) were within ±0.25 mm of the intended diameter.
"Although current cataract surgery techniques can achieve excellent outcomes, the procedure still relies on multiple manual steps," said Stephen G. Slade, MD, medical director of the company in a news release. "The LenSx femtosecond laser has been designed to advance the precision and reproducibility of key portions of the procedure, something we have seen lasers do repeatedly in other ophthalmic procedures."
The LenSx femtosecond laser is also being evaluated for lens fragmentation.
Endo Optiks Launches High-Resolution Micro-Endoscopes
Endo Optiks, Inc. (Little Silver, New Jersey) launched the High-Resolution Series of Micro-Endoscopes at the European Society of Cataract and Refractive Surgeons (ESCRS) annual meeting in Barcelona.
The new Micro-Endoscopes are designed with a 17,000 pixel fiber optic bundle to provide surgeons with a better image and a 160¡ field of view of the anatomy of the eye. The current Endoscopes by Endo Optiks, with 10,000 pixels and a 110¡ field of view, will continue to be available, according to a company news release.
The High-Resolution Endoscopes are available in two versions. The Triple Function Micro-Endoscope combines laser, light, and imaging in a 19-gauge probe, and will be available in both straight and curved tips. The Dual Function Micro-Endoscope combines light and imaging in a 20-gauge probe and comes with a straight tip.
Micro-Lens Treatment for Presbyopia
Presbia Coöperatief UA (Amsterdam, Netherlands) unveiled the Flexivue System, an implantable micro-lens treatment for presbyopia, at the ESCRS, according to a news release. Presbia is an ophthalmic device company formed from the combination of Visitome and PresbiTech in late 2008.
The 3-mm diameter Flexivue lens is made of a hydrophilic polymer and has an edge thickness of less than 20 µm. The lens is placed in a pocket created in the cornea by standard excimer lasers. The lens is inserted into the self-sealing pocket with a device developed by Presbia. The lens stays in place permanently or may be easily and safely removed and replaced with a stronger prescription if needed. The procedure typically takes less than 10 minutes, is performed on the nondominant eye, and does not require anesthesia, according to the company.
Clinical trials of Flexivue are expected to begin in several European countries by the fourth quarter of 2009, according to the company. Ioannis G. Pallikaris, MD, PhD, of the Institute of Vision and Optics of the University of Crete, will oversee the trials. Hanita Lenses (Israel) will manufacture the Flexivue lens for Presbia.
Akreos MICS IOL Launched in the United States
Bausch & Lomb Surgical launched the Akreos AO Micro Incision Lens (model MI60L), also known as the Akreos MICS IOL, in the United States. According to a company news release, the spherical, aberration-free lens is designed for implantation through a 1.8-mm incision.
Preloaded IOL Injection System Introduced to the US Market
The iSert Preloaded IOL Injection System (Hoya Surgical Optics, Inc., Chino Hills, California) has been approved for use in the United States.
According to the company, the iSert, which was has been available in Europe and Japan since 2007, provides predictable and safe insertion of glistening-free hydrophobic acrylic aspheric IOLs through a sub–2.4-mm incision. The preloaded device reportedly eliminates the risk of contamination from endotoxins associated with reusable instruments.
In other Hoya news, Jacob Vander Zanden was named Vice President of Global Marketing. In this position, Mr. Vander Zanden will be responsible for marketing strategy driving the global growth and expansion of Hoya Surgical Optics.
Three-Year Crosslinking Data Showed Visual Acuity Improvements
Corneal crosslinking (CXL) appears to be effective in improving UCVA and BCVA in eyes with progressive advanced keratoconus by significantly reducing corneal average pupillary power, apical keratometry, and total and corneal wavefront aberrations at 3-year follow-up, said Paolo Vinciguerra, MD, of the Istituto Clinico Humanitas in Milan, Italy, at the ESCRS.1 Dr. Vinciguerra is a member of the CRST Europe Editorial Board.
The prospective, controlled, clinical study included 28 patients who underwent CXL. Over the 3-year period, mean baseline UCVA changed from 0.17 ±0.09 to 0.29 ±0.08 and BCVA changed from 0.52 ±0.17 to 0.75 ±0.16 (P<.05), Dr. Vinciguerra said. A mean decrease of 0.48 D in spherical equivalent refraction was observed and endothelial cell count remained stable (P=.13).
Mean baseline simulated keratometry flattest meridian and simulated keratometry decreased (P<.05). Mean average pupillary power and apical keratometry changed from 47.50 to 41.04 D and from 58.94 to 55.18 D respectively, (P<.05), Dr.Vinciguerra reported. Mean baseline pupil center pachymetry and total corneal volume decreased (P<.05). At 3 mm, reductions were observed (P<.05) in total, higher-order, astigmatic, coma, and total spherical wavefront aberrations (P<.05).
Modified FLEx Treatment Produced Good Refractive Outcomes
A prospective, multicenter study found that small-incision femtosecond lenticule extraction (SMILE), a modified version of the femtosecond-lenticule extraction (FLEx) procedure that extracts lenticules through an 80¡ incision, produced superior refractive results when compared with the FLEx procedure. Walter Sekundo, MD, Professor and Chairman of the Department of Ophthalmology at Philipps University of Marburg, Germany, presented these results at the ESCRS.1
Ninety-one eyes of 48 patients with myopia or myopic astigmatism with a spherical equivalent of -4.75 ±1.56 D underwent SMILE with the VisuMax laser (Carl Zeiss Meditec, Jena, Germany). Follow-up occurred on day 1, week 1, and months 1, 3, and 6.
At the 6-month follow-up, 95% of eyes treated were within ±1.00 D and 79% of eyes were within ±0.50 D of intended correction, Dr. Sekundo reported. Mean spherical equivalent was -0.01 D at 1 month and 0.01 D at 6 months. A total of 83% of eyes achieved a UCVA of 20/20 or greater. However, the cylinder correction of 1.00 D showed undercorrection, Dr. Sekundo said.
No change in BCVA was observed in 53.3% of eyes. A gain of one line was achieved in 32.3% of eyes and two lines in 3.3% of eyes. A loss of one line occurred in 8.8% of eyes, two lines were lost in 1.1%, and three lines were lost in 1.1%. There was no significant increase in higher-order aberrations.
Although the refractive results of SMILE were superior to FLEx, astigmatism correction was inferior when compared with FLEx, Dr. Sekundo said. This may suggest that the cornea is more stable when no flap is created.
Global Data Positive for AcrySof Phakic IOL
Pooled outcomes at 3 years from clinical trials of the AcrySof Phakic Angle-Supported IOL (Alcon Laboratories, Inc.) conducted in the United States, Europe, and Canada revealed excellent visual acuity with accurate predictability of refraction, said Béatrice Cochener, MD, during a presentation at the ESCRS.1
Pooled outcomes were evaluated for 360 patients implanted with the AcrySof Phakic IOL in prospective global clinical trials. Study participants included adults with high myopia and refractions stable within ±0.50 D at least 12 months prior to surgery.
At 3 years, 48 of 104 patients achieved a UCVA of 20/20 or better and 101 achieved 20/40 or better. For BCVA, 84 patients achieved 20/20 or better, and all 104 achieved 20/40 or better. Postoperative refraction was within ±0.50 D of the targeted refraction in 82 patients.
Mean Near UCVA Gain With IntraCOR at 1 Year
One-year data showed that the noninvasive IntraCOR treatment (Technolas Perfect Vision, Heidelberg, Germany), or intrastromal correction of presbyopia, produced significant near visual acuity gain with stable results, said Mike P. Holzer, MD, at the ESCRS.1
The prospective clinical study, conducted at the International Vision Correction Research Centre in Heidelberg, Germany, evaluated the surgical and functional outcomes of the IntraCOR procedure with the Femtec femtosecond laser (Technolas Perfect Vision) in 25 patients, all of whom were presbyopic emmetropes.
In an interview with CRST Europe, Dr. Holzer, study investigator, said that a significant increase in mean near UCVA occurred as early as 1 day postoperative with outcomes stabilizing by 3 months. Patients achieved a mean gain of 4.5 lines of visual acuity. Additionally, mean distance UCVA remained at the preoperative level at 1 year.
The visual acuity gain is due to the slight steepening of the cornea that occurs during the procedure, Dr. Holzer said. "The IntraCOR procedure changes the biomechanics of the cornea, resulting in a slight steepening of the central part of the cornea, which in turn makes the corneal asphericity slightly more negative."
Tear Film Substitution With Viscous Eye Lubricant
According to a study conducted at the General Hospital Vienna in Austria, HPMC 2% (Croma, Korneuburg, Austria) is an effective lubricant for use during ophthalmic surgery.
A total of 36 patients received various lubricants during cataract surgery to determine each product's duration of corneal hydration and optical clarity. Results indicate that HPMC 2% is superior to balanced saline solution with regard to hydration, intraocular visualization, and retention time on the cornea. The researchers concluded that HPMC 2% offers effective corneal protection and moisturization.
HPMC 2% protects the corneal surface for up to 20 minutes and generally only requires a single application per procedure, according to company literature.
Eye Drop for Graft Rejection Inhibited Neovascularization
Antisense oligonucleotide GS-101 (Gene Signal, Lausanne, Switzerland) eye drops safely and effectively inhibited and caused a regression of corneal neovascularization, a major risk factor in corneal graft rejection, according to interim results of a phase 2 study.1
The double-masked study included 40 patients with progressive corneal neovascularization who were unresponsive to conventional therapy. Four groups of 10 patients were randomized to receive 43, 86, or 172 mg per day of GS-101 or placebo. According to the study's authors, the optimal GS-101 treatment group showed a regression of corneal neovascularization in 86% of patients. The 86-mg dose/day (43 mg/drop) of GS-101 significantly inhibited and caused a regression of corneal neovascularization (-2.04 ±1.57% of total corneal area; P=.0047) compared with the low dose (43-mg dose/day; 21.5 mg/drop), which stabilized neovascularization (0.07 ±2.94%; P=.2088). Corneal neovascularization progressed in all patients in the placebo group (0.89 ±2.15%). There was reportedly no apparent benefit to the higher dose (1.60 ±7.63%), and safety concerns were not detected.
GS-101 has been granted orphan drug status for this indication in Europe.
In Memoriam: Jeffrey P. Gilbard, MD
A tribute by Eric D. Donnenfeld, MD
Ophthalmology lost a truly unique individual on August 12, 2009, with the untimely death of Jeffrey P. Gilbard, MD, following a bicycle accident. Jeff was a gifted cornea specialist and expert on dry eye whose pioneering research led to new treatments for dry eye disease. He became interested in dry eye disease in 1976 as a medical student, and his research into this condition was supported by a grant from the US National Eye Institute. To this day, he remains the youngest scientist to receive financial support from this institution.
The core of Jeff's research and multiple publications was the breakthrough concept that the osmolarity of tears played a large role in dry eye disease. This led to the development of a hypotonic artificial tear that contained bicarbonate and potassium—a landmark event in the management of ocular surface disease. Jeff then entered the next phase of his life with the founding of Advanced Vision Research (AVR; Woburn, Massachusetts) in 1995. For 14 years, he served as AVR's CEO and chief scientific officer. His first product, TheraTears, was a great success and led to multiple additional advances. He is also considered one of the first ophthalmologists and researchers to understand the correlation between nutrition and the health of the eye, a discovery that led to the development of several holistic ophthalmic nutritional supplements.
In an era of large pharmaceutical corporations, Jeff was a refreshing maverick. He lectured tirelessly at any venue with people who would listen to his novel ideas. At major meetings, Jeff was the face of AVR. He would stand at his booth and speak with passion and conviction to anyone passing by about the importance of treating dry eye disease. Over the course of his professional career, Jeff led the charge to change dry eye from an inevitable complication of aging to a treatable disease. His discoveries offered relief to and improved the quality of life and vision of millions of dry eye patients.
Jeffrey Gilbard is survived by his beloved wife of 19 years, Liz, and his three children, whom he adored.
Eric D. Donnenfeld, MD, is a trustee of Dartmouth Medical School, Hanover, New Hampshire, and a partner in Ophthalmic Consultants of Long Island in Rockville Centre, New York.
—Compiled by Jennifer Kreatsoulas, PhD, News and Contributing Editor
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