Retin-A Micro Gel Microsphere 0.06% Now Available from Ortho Dermatologics to Treat Acne

Monday, January 22, 2018 | Acne , Product Launches and Updates , Ortho Dermatologics


Retin-A Micro (tretinoin) gel microsphere 0.06% is now available commercially to healthcare professionals. The FDA approved Ortho Dermatologics' Supplemental New Drug Application (sNDA) for Retin-A Micro (tretinoin) gel microsphere 0.06% for topical application in the treatment of acne vulgaris on October 24, 2017.
 
“The supplemental approval of Retin-A Micro gel microsphere 0.06% builds upon our heritage as a leader in developing innovative acne therapies that meet the evolving needs of our customers and their patients,” said Bill Humphries, executive vice president and group company chairman, Ortho Dermatologics, a division of Valeant Pharmaceuticals North America, LLC. “As acne continues to be a widely prevalent skin disease, we are committed to introducing more treatment options for this large and growing patient population.”
 
Clinical data provided to the FDA showed 98.7 percent (252/255) and 94 percent (210/224) of patients found Retin-A Micro to be tolerable
·         In the 0.04% study no severe irritation was reported at week 2, the typical peak of irritation, and only 1.3 percent (3/255) of subjects discontinued due to irritation
·         In the 0.1% study no more than 3 percent of subjects reported severe irritation and only 6 percent (14/224) discontinued as a result
 
Retin-A Micro  (tretinoin) gel microsphere 0.06% features a unique microsponge delivery system technology that helps to control the release of tretinoin3 and improves photostability, even when used in conjunction with benzoyl peroxide4.  A pump delivery system also allows for controlled dispensing5 and consistent dosing6.
 

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