Salvat Laboratories announced that it has submitted a New Drug Application (NDA) to the FDA for the approval of the first ocular corticosteroid formulated in a nanoemulsion for inflammation and pain in post-ocular surgery patients.
This submission comes after two successful phase III clinical trials conducted between 2020 and 2021. This new and pioneering corticosteroid in ophthalmology, clobetasol, was tested in more than 400 patients in the United States in over 40 different specialized centers, demonstrating the efficacy and safety of this innovative approach. Read more about the clinical trials here.
Salvat has developed IMPACT-SVT, a patented nanoemulsion drug delivery technology that improves drug penetration and bio-adhesion, providing excellent comfort. IMPACT-SVT made it possible to develop SVT-15473 using clobetasol; this
