The FDA decision on Sol-Gel Technologies Ltd.’s (SLGL) TWYNEO, proposed for the treatment of acne vulgaris, is expected on August 1.TWYNEO is a fixed-dose combination of encapsulated Benzoyl peroxide, 3%, and encapsulated Tretinoin, 0.1%, cream. Tretinoin and Benzoyl peroxide are widely prescribed separately as a combination treatment for acne. However, Benzoyl peroxide causes degradation of the Tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation.In TWYNEO, Benzoyl peroxide and Tretinoin are separately encapsulated in silica using Sol-Gel’s proprietary micro-encapsulation technology that will help protect Tretinoin from oxidative decomposition by Benzoyl peroxide, thereby enhancing the stability of the active drug ingredients.If approved, TWYNEO is expected to bring in peak sales of $350 million to $400 million, according to the company.Sol-Gel has a 5-year exclusive license agreement with dermatology company Galderma for the commercialization of TWYNEO in the United States.SLGL closed Monday’s (Jul.26, 2021) trading at $12.11, up 0.08%.