Salvat, the international laboratory that has developed and owns Cristalmina, Gama Relive, Tebarat and Cetraxal products, 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 submission to the FDA follows the success of two phase III clinical trials conducted between 2020 and 2021. Clobetasol, a new, cutting-edge corticosteroid in ophthalmology, was tested in more than 400 patients at 40 specialized centers in the U.S., demonstrating the efficacy and safety of this treatment.

Innovation in the industry

Salvat has developed IMPACT-SVT, a patented nanoemulsion technology (emulsion with nanometric-sized droplets) for the administration of drugs that improves drug penetration and bioadhesion, providing improved comfort.

IMPACT-SVT has allowed the development of SVT-15473 using clobetasol. This “super-strong” corticosteroid has never been used as an eye drop before. Its presentation in single-dose vials offers great advantages over other alternatives on the market. In addition to its efficacy and safety, clinical trials have shown that, unlike many other corticosteroids, it has a very low impact 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 advantage is that it is not necessary to shake the product before use, since the nanoemulsion guarantees a uniform concentration in each drop. The unique nanoemulsion formulation provides a more pleasant administration to the patient, and is characterized by better distribution on the ocular surface, more efficient absorption, and the absence of blurred vision or discomfort after application.

Designed with BFS (Blow-Fill-Seal) technology, a sterile, advanced and automated manufacturing system for single-dose vials, the new drug will be produced on the Salvat USA Inc. manufacturing line in Miami, FL and at Pharmaloop SL, the Salvat plant in Alcalá de Henares (Madrid).

Salvat has invested more than €20 million euros in this project, and the presentation of the NDA documentation is a big step in its goal of becoming a benchmark in ophthalmology.

“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.”