Biopsy Assesses Ocular Melanoma

Procedure Predicts Risk of Highly Aggressive Cancers.

A new procedure pioneered by UCLA�s Jules Stein Eye Institute could reveal valuable information to ocular melanoma patients and their physicians, providing a clear basis for making treatment and lifestyle choices.
Researchers have developed a technique to biopsy tissue from the living eye to predict which tumors possess high metastatic risk.
The findings were reported in the January issue of Ophthalmology.
�For the first time, we have demonstrated that it�s safe and feasible to perform a biopsy in the living eye to obtain clear results about whether a tumor has metastatic potential or not,� explained Tara Young, M.D., assistant professor of ophthalmology at UCLA�s Jules Stein Eye Institute and a Jonsson Comprehensive Cancer Center researcher. �Identifying patients at high risk for metastasis is an important first step toward reducing the death rate of this cancer, which kills nearly half of its patients.�
Ocular melanoma attacks the pigment cells in the retina. Earlier studies discovered that patients who are missing one copy of chromosome 3 in their tumor tissue are more likely to have highly aggressive cancers. Half of these patients die within 5 years, due to metastasis to the liver and other organs.
Using this genetic marker as the starting point for their research, UCLA scientists studied a group of patients who had been newly diagnosed with ocular melanoma. Each patient was scheduled for a standard eye surgery to temporarily implant a small disc designed to shrink the tumor with radiation and possibly save the eye.
For the first time, UCLA surgeons used an ultra-fine needle to collect cells from the cancer before surgery and send the sample to the lab for culture. After growing the tumor cells, a geneticist analyzed them to determine whether they were missing a copy of chromosome 3.
Of the nine patients in the UCLA study who underwent biopsy, four had tumors identified as high-risk for aggressive metastasis, and five were identified as low-risk.
�When physicians know upfront which patient has a poor prognosis, they will monitor the person more closely to detect metastasis earlier and consider more aggressive treatments to increase their chance of survival,� Dr. Young emphasized. �Knowledge of metastatic risk will also help patients and their physicians decide whether to pursue clinical trials of experimental therapies that target metastasis.
�Patients understand that no good treatment exists after their cancer spreads � everyone wants to know what their metastasis risk is,� she added. �If the risk is low, it�s a giant relief and emotional burden off their shoulders. If the risk is high, it enables them to plan arrangements for their family and finances, and make the most of their remaining time alive.�

AMO Recalls Contact Lens Solution

Contaminated Product was Produced in China.

Advanced Medical Optics, Inc. (AMO) has completed a nationwide, voluntary recall of certain lots of its 12-ounce Complete MoisturePlus multipurpose contact lens care solution and Active Packs. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at its manufacturing plant in China, AMO responded quickly and recalled 18 lots distributed in the United States that were manufactured on the same production lines during the same production period.
To date, no incidents of infection have been reported in the United States from the contamination.
�This is a production-line issue and is not related to our formulations, which have been used safely by contact lens wearers for years,� said Jim Mazzo, AMO chairman, president and CEO. �While we believe the likelihood of patients experiencing an adverse reaction is low based on our investigation to date, we implemented this voluntary recall as a precautionary measure. This issue is limited to two of the four production lines in the China facility. We have temporarily ceased all manufacturing there to clean and sanitize the plant. We want to be abundantly certain that eyecare practitioners and their patients know they can continue to rely on and trust AMO for products that meet high quality standards. We are working aggressively to replace recalled product and minimize the inconvenience this action may cause.�
AMO expects the recall to reduce revenue for the final weeks of 2006 and all of 2007 by a total of $40 million to $45 million. This is due to expected product returns, supply shortages and temporary lost market share, primarily in Japan and Asia Pacific, where the vast majority of the China-produced product is shipped.
AMO now expects 2006 adjusted earnings per share (EPS) to be between $1.30 and $1.40, compared to previous guidance of $1.85 to $1.90. For 2007, the company now expects adjusted EPS to be between $1.85 and $2.00.

IN THE NEWS.

Alcon recalls dry eye medication. Alcon Laboratories, Inc., has announced that it is initiating a voluntary recall of Systane Free Liquid Gel eye drops after foreign material, later found to be mold, was discovered and reported by 11 consumers. Alcon says that over 5 million bottles of Systane Free have been distributed in the United States and Puerto Rico since January 2006. The recall is only for the Systane Free brand and does not affect any other formulation in the Systane family of products. According to the company, the bottles containing the foreign material were returned to Alcon and, upon subsequent testing, were found to contain mold. Alcon says that the possibility of infection from these molds is low and that there have been no reports of fungal infection from any bottles of Systane Free. Additionally, testing of the returned bottles and samples from those lots and review of manufacturing records show that the contamination is specific to the formulation and is not a result of manufacturing error. The estimated pre-tax cost to the company from the recall is estimated to be $8 million to $10 million. Alcon says that the recall will not have a �material impact� on 2007 sales or profit forecasts. K Visian toric approval delay. STAAR Surgical Company said the FDA has requested additional clinical data for its Visian Toric phakic IOL (TICL) that will delay approval of the lens beyond the company�s previous expectations. The FDA�s Office of Device Evaluation has requested that STAAR amend its submission to provide more information and analysis of clinical data to permit the agency to complete its review of the TICL�s safety and effectiveness. The FDA�s evaluation could extend the review period by up to 180 days. �As a result of the scope of the information requested, any potential approval of the product will take longer than we originally anticipated,� said David Bailey, CEO of STAAR. �The FDA�s request is not unusual given that it is considering the submission for a first-of-its kind product.� K Tracey/AMO agreement. Advanced Medical Optics (AMO) and Tracey Technologies have signed a new licensing agreement that gives AMO non-exclusive worldwide rights to Tracey�s ray-tracing wavefront technology. Tracey had licensed the technology to VISX, an AMO acquisition.

Medicare fee cuts halted. A 5% reduction in Medicare physician payments due to go into effect Jan. 1 has been reversed. Congress has mandated a 1-year freeze in the Medicare conversion factor at the 2006 level, which will halt the reduction. However, the additional reductions to ophthalmology due to the changes in practice expense and work relative value units will still go into effect.
In addition, Congress approved a controversial 1.5% bonus for practices which meet specific Medicare quality-of-care criteria. Bonus payments are scheduled to begin in the second half of 2007.
Mifepristone in trial. Global bio-nanotech company pSivida Ltd., which specializes in drug-delivery systems for ophthalmic drugs, has initiated a phase 2 clinical trial of Mifepristone as an eye drop treatment for steroid-associated elevated IOP.
Mifepristone is a steroid receptor antagonist already approved by the FDA. This study represents a potential new use of an existing drug, made possible by a new delivery system.
Alimera drug approved. Alimera Sciences Inc., a developer of ophthalmic pharmaceuticals, said the FDA has approved its prescription-to-OTC-switch New Drug Application (NDA) for Alaway (ketotifen fumarate ophthalmic solution 0.025%). Alaway, a multiple action eye anti-allergic, is Alimera�s first NDA submission and the first to win approval. Indicated for the temporary relief of itchy eyes, Alaway will be marketed OTC with a prescription-strength active ingredient.
In related news, Alimera said it has completed the second tranche of its Series B financing, receiving $15.9 million in additional venture capital. This represents the culmination of the Company�s Series B financing of $31.8 million secured in November 2005, at which time Alimera received an initial $15.9 million in proceeds.
The additional resources will be used to further develop Medidur, Alimera Sciences� treatment for diabetic macular edema currently in phase 3 trials. The company will also use these funds to expand its development pipeline. B&L licenses anti-inflammatory. Bausch & Lomb has obtained an exclusive worldwide license from Schering to develop and market a selective glucocorticoid receptor agonist (SEGRA) for the nonsystemic treatment of eye disorders.

Bausch & Lomb will evaluate the compound�s potential as a novel anti-inflammatory medication with an improved ocular safety profile. Glucocorticoids are the most potent and frequently used anti-inflammatory compounds but their value is limited by side effects, including glaucoma induction. SEGRAs use a distinct molecular mechanism after binding to a glucocorticoid receptor and may demonstrate a superior effect/side-effect profile when compared to standard glucocorticoids. Preclinical evaluation is underway. OM