Salvat Laboratories announces submission of New Drug Application to the U.S. FDA for Clobetasol Nanoemulsion for treating inflammation and pain after ocular surgery

Salvat LaboratoriesSalvat 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 “superpotent” corticosteroid has never been used before as eye drops. Its presentation in single-dose vials offers superior advantages over other established alternatives that are readily available. In addition to its efficacy and safety, clinical trials have shown that it has very low impact on intraocular pressure.

After a standard 14-day course of treatment, the therapy has proven to have no rebound effect in the following 2 weeks, hence it doesn’t require a gradual decrease in dosage towards the end of treatment. There is no need to shake the product before use, as the nanoemulsion ensures even drug concentration in every drop. The exclusive nanoemulsion formulation (emulsion with drops of nanometric size) provides additional comfort to the patient. It also features better coverage of the ocular surface, more effective absorption, and no blurred vision or discomfort after application.   

Designed with Blow-Fill-Seal technology, an advanced, sterile, and automated single-dose vials manufacturing system, the new drug will be produced on the manufacturing line of Salvat USA in Miami, and at Salvat’s manufacturing site Pharmaloop S.L. in Alcalá de Henares (Madrid).

Salvat Laboratories has invested over 20 million euros into this project, and this NDA submission is a step in its goal of becoming a key player in ophthalmology. "I am beyond thrilled to have submitted our FDA application for the future launch of this new corticosteroid. Once authorized, post-ocular surgery patients will see their treatment improve significantly. Additionally, the rest of the projects that are currently underway reinforce our ophthalmology line as one of our main areas of research and development and strengthen the company's strategy to position itself as one of the main players in the field of ophthalmology worldwide in the coming years," said Alberto Bueno, CEO of Salvat.

About Salvat

We are a private capital pharmaceutical company, established in Barcelona in 1955, today managed by the 3rd and 4th generation of the family.

As a Company we focus on organic growth, with a long term vision and the purpose of generate innovation and creating jobs. As a family, we manage the Company keeping ethics at its core.

Today, with more than 400 employees in Spain, three manufacturing plants in Barcelona, Madrid and Tamarac (Florida), two marketed products in the US and a broad international presence, we envision a great future for Salvat.

For more information, please visit https://svt.com

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