Latisse, a drug to promote longer, thicker, darker eyelashes got the recommendations of FDA advisory panel for approval. However the FDA panel also recommended further studies to assess Latisse's use in certain groups of patients, such as young patients and people who lost their eyelashes because of chemotherapy.
If the FDA approves Latisse, it will be a prescription drug, not an over-the-counter cosmetic.
The FDA approved Lumigan in 2001 as an eyedrop. Eyelash growth is a known side effect of the drug. Allergan Inc., the drug company that makes Lumigan is now seeking U. S. approval to market the new use under the brand name Latisse.
The company conducted a study to see how well it promoted eyelash growth, thickness, and darkness when dabbed like an eyeliner at the roots of the eyelashes on the upper eyelid. During study, 137 people used Latisse and 141 people used a placebo solution for 16 weeks. Analysis of data showed that Latisse group had thicker, longer, darker eyelashes as compared to placebo group. And people in the Latisse group reported more satisfaction with their lashes than people who used the placebo.
Study revealed there were generally temporary and mild side effects where included eye redness, which stopped when the use of the drug was discontinued. However no cases of iris color changes were reported during the study. Each Latisse dose uses only 5% of a Lumigan drop.
The company news release said that Allergan anticipates launching Latisse in 2009.
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