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Allergan Files Lawsuit Against Cosmetic Companies Over Use of Bimatoprost

MAKERS OF EYELASH ENHANCERS FACE ACCUSATIONS OF PATENT INFRINGEMENT

Drug manufacturer Allergan Inc. has filed a patent-in-fringement lawsuit against seven companies in the U.S. District Court in Santa Ana, Calif. The suit claims the companies are marketing and selling eyelash-growth products that contain the glaucoma drug bimatoprost (Lumigan, Allergan), which has the side effect of eyelash growth.

Among the seven defendants: Derma-Quest Skin Therapy (DermaLash), Athena Cosmetics (RevitaLash) and Civic Center Pharmacy (Luxette). Many of the lash enhancers come in mascara-like containers with applicators similar to those used for mascara.

Allergan has requested a court order to preclude the companies from selling these and the other products in question. A spokesperson for Allergan said it's the company's policy not to comment on pending litigation.

Meanwhile, a recent article in The Wall Street Journal revealed that Allergan may be testing bimatoprost for exclusive lash use. A spokesperson for the company says Allergan has developed intellectual property in eyelash enhancers, but has not made any public disclosures about it.

In related news, the Food and Drug Administration (FDA) seized $2 million worth of tubes of Age Intervention Eyelash, by Jan Marini Skin Research, another defendant in Allergan's lawsuit.

The reason for the seizure: The FDA said it considers the product an "unapproved and misbranded drug" because Jan Marini Skin Research marketed Age Intervention Eyelash as an eyelash enhancer, yet never showed it to be safe and effective, and the FDA never approved the product, says an FDA press release.

That same press release deemed Age Intervention Eyelash an "adulterated cosmetic," as it contains bimatoprost. Research has shown that bimatoprost may cause increased pigmentation of the iris and lid, which may be permanent, according to Lumigan's final printed labeling. The labeling also reveals reports of macular edema, including cystoid macular edema, and that as a result, you should use it with caution in aphakic patients, pseudoaphakic torn-posterior-lens-capsule patients and those with known risk factors for macular edema. Among other reported adverse effects: conjunctival hyperemia and ocular pruritis.

Further, research has shown that patients currently using prescription bimatoprost in conjunction with the Age Intervention Eyelash, may increase their risk of optic-nerve damage, which could lead to blindness. This is because the extra dose in Age Intervention Eyelash may decrease the efficacy of the prescription drug, according to the FDA press release.

"Because this medication may potentially cause edema, the FDA should definitely pursue research into identifying whether there is a similar effect when applied to the eyelids alone," says John B. Gelvin, a Kansas City, Mo., O.D., and member of the Optometric Glaucoma Society. "Until such research is conducted, we, as O.D.s, need to make our female patients aware that these products may have ocular consequences."

Vistakon Tests Optometry Business 1010 Course

TRIAL-RUN CLASS REVEALS PRACTICE SUCCESS HINGES ON STAFF

■ Staff can make or break an optometric practice. That was the message of the "Keys to Successful Staff Development," an all-day practice-management course, held at The Vision Care Institute satellite location at the Pennsylvania College of Optometry in Elkins Park, Pa., on November 10. The course, still under development, is part of Vistakon's Optometry Business 101 series, an array of practice-management courses that seek to help optometrists better their practices.

Optometrists Walter D. West of Brentwood, Tenn. (also the Chief Optometric Editor of OM), and George Boulware, Ph.D., of Nashville, Tenn., taught the course, which provided both practical and legal information regarding the recruitment, selection, retention, benefits and training of employees. Among their many lessons: If you overlook satisfying the social (work environment) and technical (education, etc.) needs of your employees, they'll become unhappy, which can lead to a "work-just-enough-not-to-get-fired" mentality. This mentality, in turn, can lead to a lack of office efficiency, poor interactions with patients and a decrease in your practice revenue.

A sampling of their advice to prevent this mentality: Provide a job description to the candidate that accurately lists the nature and requirements of the job. Also, actively recognize the employee's contribution to your practice. You can do this verbally or with a thank-you note, flowers, balloons, candy, gift certificates, etc. Positive reinforcement increases the probability that the person will stay motivated, the speakers said.

Roughly 20 optometrists, invited by Vistakon, participated in the trial-run interactive course. Their job: to assess its strength as a practice-management class.

"We use interactive simulations that facilitate adult learning to make the course engaging and challenging," said Derrick L. Artis, O.D., M.B.A., F.A.A.O., director of customer development at Vistakon, who developed this and other Business 101 programs. "… Doctors left with valuable tools to be implemented in their practice the very next day."

The Vision Care Institute plans to launch the full-scale program in the second quarter of this year. OM will publish more information on this management course, as it becomes available.