Advanced Polymer's First Rx Product Cleared In USA

Advanced Polymer Systems has received clearance from the US Food andDrug Administration for its topical acne treatment, Retin-A Micro (0.1% tretinoin gel). This is the first ethical pharmaceutical containing Advanced Polymer's patented Microsponge delivery systems to reach the market, says APS.

Johnson & Johnson subsidiary Ortho Dermatological markets the original formulation of Retin-A in the USA, and is also the license holder for Retin-A Micro. Retin-A is the most prescribed acne treatment in the $500 million prescription acne market, but is limited by its potential for skin irritation. This new formulation reduces the potential for irritation while maintaining product efficacy, says APS.

$3 Million Milestone The FDA approval sparked a $3 million payment to APS, which will also receive royalties on sales when the product is launched in the first quarter of this year. APS hopes that this new formulation will increase the US market for tretinoin beyond its current level of $120 million.