Salvat Laboratories has submitted the NDA documentation for a new drug application to the U.S. Food and Drug Administration (FDA) for approval of Clobetasol, the first ocular corticosteroid formulated in a nanoemulsion for inflammation and pain in patients undergoing eye surgery.
The FDA filing comes after two phase III clinical trials that were successfully completed between 2020 and 2021. A novel, cutting-edge corticosteroid used in ophthalmology called clobetasol has been evaluated on more than 400 patients at 40 specialized facilities in the United States, proving its effectiveness and safety.
For the administration of drugs, Salvat has created IMPACT-SVT, a proprietary nanoemulsion technology (emulsion with nanometric-sized droplets) that enhances drug penetration and bioadhesion while also enhancing comfort.
IMPACT-SVT has allowed the development of SVT-15473 using clobetasol. There is no history of using this "super-strong" corticosteroid as an eye drop. Its delivery in single-dose vials has many benefits over competing products on the market. In addition to its efficacy and safety, clinical trials have revealed that, in contrast to many other corticosteroids, it has a very low effect on intraocular pressure.
Following standard 14-day treatment, therapy has been shown to have no rebound effect over the next 2 weeks, thus no dose tapering is required at the end of treatment. Another benefit is that the product doesn't need to be shaken before use because the nanoemulsion ensures a consistent concentration in every drop.
The particular nanoemulsion formulation offers a more pleasant delivery experience for the patient and is distinguished by better ocular surface distribution, more effective absorption, and the absence of post-application blurred vision or discomfort.
Designed with BFS (Blow-Fill-Seal) technology, a sterile, advanced and automated manufacturing system for single-dose vials, the new drug will be manufactured on the Salvat USA Inc. manufacturing line in Miami, Florida, and at Pharmaloop SL, the Salvat facility in Alcalá de Henares.
The presentation of the NDA documents is a significant step toward Salvat's objective of establishing a benchmark in ophthalmology, in which it has invested more than €20 million.
“I am proud to have submitted our application to the FDA for the future launch of this innovative corticosteroid,” said Alberto Bueno, CEO of Salvat. “Once authorized, patients will see their post-surgical treatment significantly improved. On the other hand, the rest of the projects that we have underway reinforce our line of ophthalmology as one of our main areas of research and development, and strengthen the company's strategy of positioning itself as one of the main players in the field of ophthalmology globally in the coming years.”