In late December, a judge for the United States District Court in Delaware upheld a May 2005 jury decision and awarded Advanced Medical Optics Inc. $213.9 million in damages resulting from willful infringement by Alcon of two AMO pa­tents for phacoemulsification equipment. The judge concluded that "the jury was presented with clear and convincing evidence that Alcon intentionally copied" the oc­clusion mode and the fluidics system from AMO's Sovereign machine. The judge further added, "I agree that this is an exceptional case, that the damages award should be trebled, and that reasonable attorneys fees should be awarded."

The judge granted AMO a permanent injunction, but that injunction has been stayed pending appeal. Once in effect, the injunction will prohibit Alcon from selling equipment with the features that infringed AMO's patents. The judge also re­quired Alcon to post a $1.8 million bond on the injunction pending ap­peal.

"The judge's decision validates the im­portance of AMO's commitment to develop superior technology that of­fers unique benefits to surgeons and the patients they serve," said AMO President and CEO Jim Mazzo. "We will continue to take all necessary steps to protect and defend the investment we make in technology on behalf of our customers and stockholders."

AMO originally filed a complaint in the U.S. District Court against Alcon in December 2003 for infringement of its patents relating to occlusion mode technology and fluidics management system. In May 2005, a jury awarded AMO $94.8 million in damages, reflecting lost profits and reasonable royalty fees through February 2005. Subsequently, the judge ruled that AMO did not sufficiently mark its patents on the equipment and reduced the award to $71.3 million. This revised amount was trebled, resulting in total damages of $213.9 million for this period.

Alcon management expressed disappointment at the ruling and said it would appeal the decision.

Because the injunction was stayed by the court, Alcon will be able to continue to sell and distribute its Infiniti Vision System and Infiniti FMS cassettes during the appeals process.  Under the court's order, existing customers and customers who purchase or lease new Infiniti vision systems while the appeal is pending will be able to use them for the life of the equipment without interruption or restriction. Alcon will continue to provide full service for all of its machines.

While this appeal is pending, Alcon will continue to develop an alternative design of its Infiniti FMS cassette, which it expects to have available in the first half of 2006. Alcon will be required to record a charge of $213.9 million in the fourth quarter related to this litigation.

 

FDA Cracks Down On OTC Products

Several recent Food and Drug Administration actions, as well as a voluntary recall by a manufacturer, center on over-the-counter oph­thalmic products.

 • FDA is advising consumers not to use Miracle II Neutralizer and Miracle II Neutralizer Gel products manufactured by Tedco Inc., in West Monroe, La., because the products are bacterially contaminated. Use of these products could pose a risk of serious adverse events such as infections, particularly in children, the elderly, and individuals with weakened immune systems who are particularly susceptible to illness.

Tedco Inc., promotes Miracle II Neutralizer for ophthalmic use, in­cluding treatment of cataracts and pink eye and as an eyewash. FDA requires that all ophthalmic products be sterile. Due to the substantial risk posed by non-sterility, Miracle II Neutralizer should never be applied to the eyes.

Tedco Inc. also markets Miracle II Neutralizer for other unapproved uses, including treatment of AIDS, cancer, Crohn's Disease, dermatitis, di­­aper rash, diabetes, ear ache, hem­or­rhoids, hives, gout, herpes, mouth ulcers, psoriasis, skin cancer and yeast infection. The firm sells Miracle II Neutralizer Gel for many of the same unapproved uses, including diaper rash, diabetes, gout, psoriasis and skin cancer.

FDA testing of Miracle II Neu­tra­lizer and Miracle II Neutralizer Gel revealed bacterial contamination and poor manufacturing conditions.

Although Tedco Inc. has been advised by FDA of the contamination found in its Miracle II Neutralizer and Miracle II Neutralizer Gel products, the firm declined to voluntarily remove the products from the market.

A number of stores sell Miracle II Neutralizer and Miracle II Neu­tra­lizer Gel, and the products are distributed and sold worldwide and sold via the Internet. The products are packaged in 8 oz, 22 oz, and one-gallon size containers.

• The FDA also announced that MBI Distributing Inc., also known as Molecular Biologics, an manufacturer of eye drops and other products, signed a consent decree that requires it to cease manufacturing and distributing drugs until it corrects manufacturing deficiencies and other violations at its Benicia, Ca. facility. The consent decree was submitted to the U.S. District Court for the Eastern District of California by the Department of Jus­tice on behalf of the FDA and is sub­ject to approval by the court.

MBI's nationwide product line includes eye drops sold under the brand names Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein and Can-C, as well as several OTC pain relieving drugs.

The FDA determined that MBI's manufacturing did not conform to the agency's good manufacturing practice requirements, among them, a lack of controls to ensure that its eye drops were sterile.

The agency has also determined that two of the firm's eye drop brands, Visitein and Clarity Vision for Life, are unapproved drugs. In addition, three of the firm's OTC pain relieving drugs, Biogesic, Bio-Ice and Bio-Heat, do not provide adequate warnings for their safe use.

MBI is enjoined from producing and distributing drugs until the firm corrects the manufacturing violations for its eye drops and its violations of the marketing approval and labeling requirements.

FDA therefore recommends that consumers, health care providers, and caregivers dispose of the Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein, and Can-C brands of eye drops and the Biogesic, Bio-Ice, and Bio-Heat pain relieving drugs and report any adverse events related to these products to MedWatch, the FDA's voluntary reporting program.

In late November, Novartis Ophthalmics voluntarily recalled a total of seven lots of two ocular products.

 • Novartis Ophthalmics recalled five lots of GenTeal Gel, a non-prescription dry-eye product. The five recalled lots are: Lot #Z12468, 10 ml, expiration date 01/2006; Lot #Z12912, 3.5 ml, expiration date 03/2006; Lot #Z12900, 10 ml, expiration date 04/2006; Lot #Z13161, 10 ml, expiration date 05/2006; and Lot #Z13314, 3.5 ml, expiration date 06/2006. The five lots include about 142,500 tubes that were distributed nationwide from March to November 2004.

The recall was based on concerns regarding sterility of the product made for Novartis by a contract manufacturer. Test results indicated the presence of mold in a small number of samples. The species of mold that is suspected is generally not harmful, but has the potential to cause an eye infection in susceptible people, especially in those with compromised immune systems.

Novartis also recalled two lots of GenTeal GelDrops due to a lack of sterility assurance. The two lots are Lot #51139, 15 ml, expiration date 07/2007; and Lot #51283, 25 ml, expiration date 07/2007. The two lots include about 12,000 dropper bottles that were distributed nationwide in October 2005. While the risk of potential contamination is believed to be very low, contaminated product could cause infections in susceptible people, and Novartis initiated the recall as a precautionary measure. The sterility assurance issues have been corrected. Only the two distributed GenTeal GelDrops lots are affected.

Medicare Payment Reduction in Limbo The outcome of the Medicare Physician Payment Reduction for 2006 was uncertain at press time. On December 19, the House of Representatives passed the Budget Reconciliation package, which would prevent the scheduled 4.4-percent reduction in 2006 Medicare physician payments by including a one-year freeze in payment rates. The Senate debated the legislation for two days. However, a procedural motion, referred to as a point of order, was raised to strike a provision related to Medicaid co-payments under the "Byrd rule," which is designed to weed out extraneous provisions unrelated to deficit reduction. The Senate was unable to waive the point of order. Therefore, the provision was stripped from the final package, thereby, amending the original conference agreement. The legislation had to go back to the House of Representatives for reconsideration. The House, however, had adjourned for the year and it was unclear at press time whether the legislators would return before the first of the year to vote on the amended conference agreement, leaving the outcome of the scheduled reduction in question.

Fugo Blade Approved for PI

The FDA cleared Medisurg Ltd.'s Fugo Blade for peripheral iridotomy creation for angle-closure glaucoma and with intraocular lenses. The new PI application allows the surgeon to place the PI in an exact location with an exact size by merely touching the iris at the desired point of iridotomy with the blunt tip of the activated Fugo Blade, according to Medisurg. The PI is created by plasma ablation of iris tissue, which may present significant advantages over present methods of tissue incision. This method is precise, quick and virtually eliminates bleeding. This method also offers surgeons a much more desirable option to create the needed PI in phakic intraocular lens surgery.

The Fugo Blade is already being sold in the United States for capsulotomy and for transciliary filtration, or Singh Filtration. The capsulotomy application allows the surgeon to "draw" the capsulotomy without need for a red reflex thereby making the original capsulotomy and capsulotomy enlargement quick and controlled. The TCF glaucoma procedure requires a sub-1mm surgical pore into the posterior chamber, a quicker procedure than trabeculectomy, and eliminates collapsed anterior chambers to minimize postop exam time. For more information, contact Medisurg Ltd. at (610) 277-3937.

PBA Seeks Patient Reps Prevent Blindness America, the Nation"s oldest non-profit organization dedicated to saving sight, is organizing a unique event to let those afflicated with eye disease (of any age) speak with their leaders in Congress about their experiences. "Eyes on Capitol Hill" will give 100 selected applicants the opportunity to meet with representatives from their state in Washington, D.C. All travel and hotel expenses will be paid for by PBA. For additional details, please see below or visit preventblindness.net or call 1 (800) 331-2020, ext. 6035.

Study: Ozone Loss Raises Cataract Incidence, Costs

A report in December's Amer­ican Jour­nal of Epidemiology suggests another reason to be concerned with the health of earth's ozone layer: cataracts.

Sheila K. West, PhD, Wilmer Eye Institute, Johns Hop­kins School of Med­icine, Bal­ti­more, and her co-authors modeled the possible consequences for U.S. cataract incidence of increases in ultraviolet B radiation due to ozone depletion. Data on the dose-response relation between ocular exposure to UVB radiation and cortical cataract were derived from the Salisbury Eye Evaluation Project, in which extensive data on cat­aract and UV radiation were collected in persons aged 65 to 84 years.

Exposure estimates were derived using estimated UV radiation fluxes as a function of wavelength. Pre­dicted probabilities of cat­a­ract were derived from the age-, sex- and ethnicity-specific ocular UV ex­posure data and were modeled under conditions of 5 to 20 percent ozone depletion. The analysis indicated that by 2050, the prevalence of cortical cat­aract will rise above expected levels by 1.3 to 6.9 percent. The authors es­timate that with the modeled ozone depletion, there will be 167,000 to 830,000 ad­ditional cases of cortical cataract by 2050. At a 2003 cost of $3,370 per cataract operation, this increase could represent an ex­cess cost of $563 million to $2.8 billion.