Personal Injury Law

Glaucoma Drug May Become Desirable Cosmetic

By Jane Akre

It's been used by thousands of patients to treat glaucoma, now a drug made by Allergan might be approved to make lashes thicker.

A panel of government experts gave Lumigan the okay Friday, saying it appears to be safe and effective way to make lashes fuller.

Allergan has asked the Food and Drug Administration to approve the Lumigan formula to enhance lashes for those 18 and older. Irvine California-based Allergan also makes Botox Cosmetic.

The panel voted unanimously that the drugs benefits outweigh its risks.  For some people, thin eyelashes present a medical condition that needs treatment.

However, the panel also suggested Allergan should conduct post-approval studies on certain patient populations, "including patients of younger age and post-chemotherapy patients with loss of eyelashes," says the company in a statement.

Teens who may apply the lash enhancer three or four times a day would be considered off-label use.

"I'm worried about off-label, nonsupervised use of this medication, and I'm concerned teenagers might use it three or four times a day instead of once," Dr. Marijean Miller, an ophthalmologist with the Children's National Medical Center in Washington, said to CBS.

Also African-Americans were not included in the drug trials.

The University of Michigan Web site lists some side effects of Lumigan, which would be marketed under the name, Latisse.

Lumigan is a class of medications known as prostaglandins that reduce eye pressure in glaucoma patients. By opening channels that drain fluids from the eye, Lumigan helps prevent damage to the optic nerve.  Side effects include:

• Red eyes
• Eye itching
• Dry Eyes
• Darkening of the iris, ie the blue, green or brown color, or the eyelids

An added and desirable side effect includes lash growth, increased thickness and darker color.

Lumigan can irritate allergies and can cause a reaction to those allergic to food, dyes or preservatives.  Pregnant women, or those who may become pregnant, are advised to tell their doctor before being prescribed Lumigan.

In 2005, the FDA sent a warning letter to Allergan accusing the company of false advertising concerning Lumigan.

Allergan would like any licensed physician to be able to prescribe Lumigan. Those younger than 18 may be able to obtain it only after seeing an eye specialist, a concern of the expert panel. 

Allergan plans to market the drug as a cosmetic treatment.  Latisse could generate more than a half-billion in annual sales for Allergan.  Shares of Allergan (AGN) rose more than five percent after the news on Friday.   

CBS News reports the drug does not go directly into the eye so should be safe.

Dr. Robert Cykiert, an ophthalmologist at New York University, told the CBS Early Show that the drug will be applied with an applicator. 

"I don't have a problem with that.  I have an experience with thousands of patients, applying to the base of the eyelashes, so it should be very safe." 

The eyelashes will shrink again in a few months after use stops, he says.  #

Full post as published by InjuryBoard on December 08, 2008 (boomark / email).