Abbott to Acquire AMO
Abbott (Abbott Park, IL) will expand its medical device unit by acquiring Advanced Medical Optics, Inc. (AMO; Santa Ana, CA). Under the terms of the agreement, Abbott will tender an offer by January 26 to purchase all outstanding AMO shares at $22 per share, for a total transaction value of approximately $2.8 billion.

The transaction value includes an estimated net debt at the time of closing. According to a joint news release from the companies, Abbott expects this transaction to be neutral to ongoing earnings per share in 2009. The increase in earnings per share is expected to begin in 2010.

Abbott's strategy to position innovative technology in leading markets prompted the Illinois-based company to pursue this acquisition, Scott Stoffel, an Abbott spokesman said in a phone interview with Retina Today. "AMO will strengthen Abbott's diverse medical device business by adding another market leading, multibillion [dollar] business to the company as well as position the company for long-term growth," Mr. Stoffel explained. Abbott does not currently have an ophthalmology platform.

"Joining forces with Abbott will fortify our position as a global ophthalmic medical device leader and enhance our ability to serve eye care practitioners and patients around the world," Jim Mazzo, Chairman and Chief Executive Officer of AMO, said in the joint news release.

Mr. Mazzo will report to John Capek, Vice President of Medical Devices, Mr. Stoffel told Retina Today. Mr. Capek currently oversees Abbott's medical devices business in the vascular, diabetes, and animal health markets. When the deal is closed, AMO will become an operating division of Abbott, and Mr. Mazzo will be President of the new business. The name of the business is not yet known.

In addition to expanding Abbott's medical device business, the company is optimistic that the combination of AMO's already strong competitive position in the LASIK surgical device market, the cataract surgical device market, and contact lens care products will bring more balance and diversity, Mr. Stoffel explained.

"AMO's business is not only geographically diverse but diverse in and of itself, participating in three segments of the large and growing vision care market," Mr. Capek said during the company's Web cast on January 12. "We expect AMO to be a steady, high-single digit grower on the topline and a profitable contributor over our long-range plan. We also expect that Abbott's global presence and distribution capabilities will further improve upon AMO's international growth opportunities, especially in emerging markets."

Abbott plans to retain the management team and organization of AMO. Furthermore, the new company will continue to be based in Santa Ana, Mr. Stoffel said.

Home Device for Monitoring AMD Expected This Year
Sightpath Medical (Bloomington, MN) announced that the ForeseeHome AMD Monitor, a home-based preferential hyperacuity perimeter manufactured by Notal Vision, Tel Aviv, Israel and distributed in the United States by Sightpath Medical, is expected to be available in late 2009. Like the clinic-based Foresee PHP, which was launched in 2004, the ForeseeHome monitors the progression of age-related macular degeneration (AMD) and detects conversion to choroidal neovascularization (CNV). The 3-to-5-minute test measures 500 retinal data points and maps defects within a patient's visual field by analyzing responses to dot deviation signals that flash on a computer screen. It is recommended that patients take the ForeseeHome test daily so that physicians can detect a patient's conversion from dry to wet AMD via telemedicine as early as possible and ultimately improve visual outcomes. Sightpath Medical reports that the ForeseeHome is currently undergoing clinical trials.

Data presented at the 2008 Annual Meeting of the American Society of Retina Specialists (ASRS) showed that the ForeseeHome demonstrated 30% greater sensitivity than the Amsler grid when used to test patients previously diagnosed with CNV. Anat Loewenstein, MD, Chairman of the Department of Ophthalmology, and colleagues at Tel Aviv Sourasky Medical Center, Israel, examined 31 patients with intermediate dry AMD and 26 patients with CNV with an initial visual acuity of 20/200 or better.

Participants underwent an Amsler grid examination and a ForeseeHome examination before treatment or routine ophthalmic examination. The researchers found that among the 26 CNV patients, 23 were positive with the ForeseeHome, compared with 15 patients with the Amsler grid. Based on this data the ForeseeHome yields a sensitivity of 88.4% vs 57.6% for the Amsler grid. Additionally, the ForeseeHome indicated no false positives among 31 intermediate AMD patients.

"The ForeseeHome is, in a way of speaking, the doctor's extension at the patient's home," Dr. Lowenstein said in an interview with Retina Today. "The device allows for earlier detection of CNV and refers back to the doctor only patients who are suspected of having CNV. We are able to monitor a high volume of patients and mainly focus on the suspected CNV patients."

New President and CEO Appointed at Alcon
Kevin Buehler will become President and Chief Executive Officer of Alcon, Inc., (Hunenberg, Switzerland) effective April 1, 2009, following Cary Rayment's retirement from the positions on March 31, 2009. Mr. Rayment will continue to serve as a director and the (non-executive) chairman of the board. Mr. Buehler will also be nominated as a board member, with shareholders voting at the annual general meeting on May 5, 2009. Mr. Buehler is currently Senior Vice President, Global Markets, and Chief Marketing Officer of Alcon Laboratories, Inc. (Fort Worth, TX).

Phase 3 Study Will Test Microplasmin for Back of the Eye Diseases
ThromboGenics NV (Heverlee, Belgium) has begun MIVI-TRUST (Microplasmin for IntraVitreous Injection-Traction Release without Surgical Treatment), a phase 3 clinical study of microplasmin for the nonsurgical treatment of back of the eye disease, primarily focal vitreomacular adhesion. This program involves two clinical trials, one in the United States and one in Europe and North America.

Focal vitreomacular adhesion is a condition in which the vitreous gel has an abnormally strong adhesion to the retina. These adhesions can cause vessel and retinal distortion, which results in deterioration of the patient's vision. Focal vitreomacular adhesion is also associated with macular hole formation, some forms of macular edema, diabetic retinopathy, and AMD.

The multicenter, randomized, placebo controlled, double-masked trials will evaluate 125 µg of microplasmin vs placebo in the intravitreal treatment of patients with focal vitreomacular adhesion. The trials will enroll approximately 320 patients from approximately 40 centers in the United States and 40 centers in Europe and North America, according to a company news release. The primary endpoint of both trials is the nonsurgical resolution of focal vitreomacular adhesion after 1 month. Efficacy and safety will also be assessed at various intervals over 6 months in both studies. ThromboGenics projects that both studies will be completed by the end of 2010.

"Microplasmin may represent an important clinical advance, as earlier clinical studies have shown that it could potentially resolve vitreomacular adhesion in a simple one-off procedure, removing the need for major eye surgery with its associated risks and costs in such cases," Steve Pakola, MD, Chief Medical Officer of Thrombo-Genics, said in a news release. "In addition, we believe microplasmin has potential for treatment of other conditions such as diabetic retinopathy and AMD, given the increasing evidence that vitreomacular adhesion plays an important part in these sight-threatening conditions."

Argus II Retinal Implant International RP Clinical Trial Expanded
Second Sight Medical Products, Inc., (Sylmar, CA) will increase patient enrollment for the Argus II Retinal Implant study throughout clinical trial sites in Europe. The 3-year feasibility study is currently under way in the United States, Europe, and Mexico for people with retinitis pigmentosa (RP).

The Argus II is the second generation of an electronic retinal implant designed for the treatment of blindness due to RP. The implant consists of an array of electrodes that are attached to the retina and used in conjunction with an external camera and video processing system to provide a rudimentary form of sight to implanted patients. The implant is reportedly designed to last a lifetime but can be safely removed if necessary.

Preliminary results in the Argus II feasibility study found that no device failures and few serious adverse events occurred in 17 individuals enrolled in the study for an average of 14 months. The most serious event resulted in removal of an implant without difficulty or harm to the patient, according to the company. Additionally, 11 study volunteers could locate a door up to 20 feet away and walk to the end of a 20-foot line drawn on the floor.

Preclinical Testing Begins for Parthenogenic Stem Cells for Treatment of Retinal Diseases
International Stem Cell Corporation (ISCO; Oceanside, CA) has begun preclinical testing of its parthenogenetic stem cells for AMD and RP, according to a news release. From its parthenogenetic stem cells, the company has created layered human tissue and transplanted this tissue into animals, the release said.

According to the company, ISCO's human parthenogenetic stem cells can be matched to common immune types, reducing the chance of transplant rejection among large segments of the population. Because they are created from unfertilized human eggs, they do not require the destruction of human embryos.

"Intact layers of retinal progenitor cells have been shown to restore lost visual responses in several retinal degeneration rodent models," Hans Keirstead, PhD, Co-Director of the Sue and Bill Gross Stem Cell Research Center at the University of California, Irvine, said in a news release. "Thus, we are developing intact retinal layers derived from International Stem Cell's human parthenogenetic stem cells which could become a sustainable, US Food and Drug Administration (FDA)-approved therapeutic supply for patients with retinal degenerative diseases."

Industry Efforts In AMD
MacuClear, Inc. (Plano, TX), will collaborate with Mystic Pharmaceuticals, Inc. (Austin, TX), for its upcoming phase 1/2 human clinical trials of MC 1101 for the treatment and prevention of the progression of AMD. MC 1101 will be delivered via Mystic's VersiDoser, an eye drop dispenser that delivers a unit dose of drug to the eye.

The public/private venture Life Sciences Greenhouse of Central Pennsylvania (LSGPA) invested $500,000 in Apeliotus Vision Science, Inc. (Hershey, PA), for the commercialization of the company's AMD detection test, AdaptDx. The AdaptDx measures the eye's ability to adapt to the dark. In an initial study, the device detected the onset of AMD before it became clinically evident, according to a news release. The AdaptDx test is reportedly noninvasive and takes less than 15 minutes.

3-D Measurement Software Granted FDA Clearance
Topcon Medical Systems, Inc. (Paramus, NJ), has received FDA clearance for the enhanced 3D OCT-1000 TrueMap Measurement Software as an addition to the previously cleared 3D OCT-1000 Optical Coherence Tomography System, according to a company news release. The software allows users to view four layers of the retina, including the inner limiting membrane, the photoreceptor inner and outer segment junction, retinal pigment epithelium, and Bruch's membrane. In addition, the software is compatible with the Stratus 1 OCT system (Carl Zeiss Meditec, Dublin, CA).

The cost of the 3D OCT-1000 TrueMap Measurement Software is included in the cost of the Topcon 3D OCT-1000. Additionally, the measurement software upgrade package is included in the cost of the 3D OCT-1000 warranty. Customers who have purchased the warranty will be upgraded to the measurement software at no additional charge, according to the company.

Imaging System Received Marketing Clearance
The US Food and Drug Administration (FDA) has granted Opko Health, Inc. (Miami, FL) 510(k) clearance to begin marketing the Spectral OCT SLO Combination Imaging System in the United States, according to a company news release. The Spectral OCT SLO is a noncontact, high-resolution, noninvasive tomographic and confocal imaging device indicated for in vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of posterior ocular structures including the retina, macula, retina nerve fiber layer, and optic disk. In addition, the system can image the cornea, sclera, and conjunctiva. Opko's imaging device is currently marketed internationally by the company's subsidiary, Opko Instrumentation, LLC.

Inflammatory Factors Contribute to Severity of DME
A retrospective case-control study suggested that inflammatory factors influence the severity of diabetic macular edema (DME). The findings are published in Ophthalmology.

Hideharu Funatsu, MD, and colleagues at the Tokyo Women's Medical University, Japan, measured levels of vascular endothelial growth factor (VEGF), intercellular adhesion molecule (ICAM)-1, interleukin (IL)-6, monocyte chemotactic protein (MCP)-1, and the anti-inflammatory pigment epithelium-derived factor (PEDF) in vitreous fluid samples obtained during vitreoretinal surgery in 53 patients with DME, 15 patients with nondiabetic ocular disease, and eight diabetic patients without retinopathy.

VEGF, ICAM-1, IL-6, and MCP-1 were significantly higher in patients with DME than in nondiabetic patients (P<.05) or diabetic patients without retinopathy (P<.05). The PEDF level was significantly lower in patients with DME than in nondiabetic patients (P<.05) or diabetic patients without retinopathy (P<.05).

Vitreous levels of VEGF, ICAM-1, IL-6, and MCP-1 were significantly higher in patients with hyperfluorescent DME than in those with minimally fluorescent DME (P=.0018, P=.0022, P=.0032, and P=.0053, respectively). Conversely, the vitreous level of PEDF was significantly lower in hyperfluorescent DME than in minimally fluorescent DME (P=.0134). Furthermore, the investigators found that vitreous levels of VEGF, ICAM-1, IL-6, MCP-1, and PEDF were significantly correlated with the retinal thickness at the central fovea (P<.0001, P<.0001, P=.0282, P=.0009, and P=.0466, respectively).

VEGF and ICAM-1 had a stronger influence on the severity of DME than the other factors (P=.0004 and P =.0372, respectively), the authors concluded.

Endophthalmitis Incidence With Office-Based Injections Low
The rate of endophthalmitis associated with office-based intravitreal injections of bevacizumab (Avastin, Genentech) and ranibizumab (Lucentis, Genentech) is low, with an incidence of approximately one in 4,500 injections, according to a study in Retina.

In the retrospective, consecutive, multicenter case series, conducted by David R. Fintak, MD, of the Barnes Retina Institute, St. Louis, MO, and colleagues, 12,585 injections of intravitreal bevacizumab and 14,320 injections of intravitreal ranibizumab were given to patients. At least 4 weeks after the injection, three (0.02%) patients who received bevacizumab and three (0.02%) patients who received ranibizumab developed endophthalmitis. Of these six patients, four were culture positive.

CORRECTION
In the December 23, 2008, Retina Today enews, the story "Canon to Distribute OCT Products" mistakenly suggested that Canon USA (Lake Success, NY) is now distributing two optical coherence tomography (OCT) products from Optopol Technology SA (Zawiercie, Poland). Canon demonstrated the synergy between the company's retinal camera systems and two of Optopol's OCT products at the annual American Academy of Ophthalmology meeting in Atlanta. The OCT products showcased by Canon are currently not for sale or clinical use, and are for demonstration purposes only.