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FDA Ponders Prescription for Luscious Lashes
Talk about your unintended consequences!
Back in 2001, shortly after the FDA approved marketing of the eyedrop bimatoprost (trade name Lumigan) for use in treating glaucoma, doctors and patients began noticing something very unusual.
Patients who used bimatoprost observed that their eyelashes were growing longer and more plentiful - males and females alike. The women were ecstatic! Besides providing effective control over elevated intraocular pressure, an unanticipated side effect was further boosting its popularity (and sales!)
This phenomenon was first reported during controlled placebo studies wherein one eye got bimatoprost and the fellow eye received the same eyedrop solution without the active ingredient. Yep, the bimatoprost eyes had lower pressures and lustrous lashes.
Now, drugmaker Allergan is ready to take it to the next level. Allergan has applied to the FDA for permission to sell the prescription eyedrop as a cosmetic treatment to enrich lashes.
So far the regulatory journey has been relatively smooth. A randomized study involving 278 volunteers proved that bimatoprost was a safe and effective way to enhance eyelash appearance. No serious adverse events were reported.
Cosmetic bimatoprost (sold under the brand name Latisse) will be applied directly to the upper eyelids only - not plopped into the eye like its predecessor. True, if Latisse gets into the eye the intraocular pressure may temporarily go down a few points but there are very few patients (clearly identified) for whom this may cause problems.
This isn't the first time Allergan has successfully identified new uses (and new revenue streams) for its products. Ever hear of Botox? Eye doctors were the first to use Botox to weaken overacting eye muscles and to quiet blepharospasm. Then Allergan found a profitable new wrinkle for the drug!
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Back in 2001, shortly after the FDA approved marketing of the eyedrop bimatoprost (trade name Lumigan) for use in treating glaucoma, doctors and patients began noticing something very unusual.
Patients who used bimatoprost observed that their eyelashes were growing longer and more plentiful - males and females alike. The women were ecstatic! Besides providing effective control over elevated intraocular pressure, an unanticipated side effect was further boosting its popularity (and sales!)
This phenomenon was first reported during controlled placebo studies wherein one eye got bimatoprost and the fellow eye received the same eyedrop solution without the active ingredient. Yep, the bimatoprost eyes had lower pressures and lustrous lashes.
Now, drugmaker Allergan is ready to take it to the next level. Allergan has applied to the FDA for permission to sell the prescription eyedrop as a cosmetic treatment to enrich lashes.
So far the regulatory journey has been relatively smooth. A randomized study involving 278 volunteers proved that bimatoprost was a safe and effective way to enhance eyelash appearance. No serious adverse events were reported.
Cosmetic bimatoprost (sold under the brand name Latisse) will be applied directly to the upper eyelids only - not plopped into the eye like its predecessor. True, if Latisse gets into the eye the intraocular pressure may temporarily go down a few points but there are very few patients (clearly identified) for whom this may cause problems.
This isn't the first time Allergan has successfully identified new uses (and new revenue streams) for its products. Ever hear of Botox? Eye doctors were the first to use Botox to weaken overacting eye muscles and to quiet blepharospasm. Then Allergan found a profitable new wrinkle for the drug!
Related Topics:
