Eyelash Growth Drug On Potential Rise

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Irvine-based Allergan Inc., the manufacturer of Botox, plans to submit a new drug application to the FDA this fall for the use of bimatoprost in stimulating eyelash growth. Bimatoprost is FDA-approved for treatment of glaucoma and is marketed by Allergan under the brand name Lumigan in the United States and Canada.

If approved by the FDA, the bimatoprost would be available only by prescription.

Dr. William Philip Werschler, assistant clinical professor of medicine and dermatology at the University of Washington School of Medicine, was an investigator in the bimatoprost clinical trials for the eyelash growth product and said the results showed significant lash growth with none of the side effects associated with bimatoprost’s use in the treatment of glaucoma, such as altered pigmentation of eyelid skin and eye color.

Allergan says that those who use Lumigan may also suffer other side-effects, including redness of the eyes and itchiness. It also points out that the increased growth of eyelashes is not permanent.

Heather Katt, senior manager for corporate communications for Allergan,  confirmed the bimatoprost  findings. She said 80 percent of patients participating in the clinical program observed eyelash growth within three to four months of treatment.

Allergan estimates  that global peak sales of its eyelash-growth drug will exceed $500 million per year.

American regulators are worried that shops are selling unlicensed  treatments containing bimatoprost. FDA agents recently seized thousands of tubes of a cosmetic called Age Intervention Eyelash. The FDA said that the treatments were “unapproved and misbranded,” although it said that it had not seen any evidence of harm to patients.

Allergan said that it took a dim view of those who copied its product. “We are very aggressive in protecting our intellectual property . . . we have already filed patent infringement lawsuits against companies that we believe are infringing our intellectual property regarding eyelash growth.”

Added Allergan: “Anyone who takes an active drug ingredient and then concocts a product to sell for eyelash growth is violating FDA law by selling an unregulated and unapproved drug that has not been subject to rigorous quality-assurance  requirements associated with pharmaceutical manufacturing.”

In Britain, 360,900 prescriptions for Lumigan were dispensed last year, a 40 per cent rise compared with 2005. The Medical and Healthcare products Regulatory Agency (MHRA) has expressed concern that the drug was possibly being used for its cosmetic benefits rather than treating glaucoma. In the U.S., doctors can prescribe the drug for cosmetic purposes because  it has already been approved by the FDA. The MHRA said: “Eyelash growth is a known side-effect of Lumigan. Lumigan and similar medicines  are only available in the UK on prescription from a doctor and would not be provided for cosmetic indications.”



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