Salvat Laboratories presented Phase III clinical trials results of Clobetasol Nanoemulsion for treating inflammation and pain after ocular surgery at the 2023 ARVO Annual Meeting
Salvat Laboratories, the international pharmaceutical company focused on the development, manufacturing, and commercialization of ophthalmology treatments, announced the results of phase III clinical trials of its most potent ophthalmic corticosteroid in the global ophthalmology market at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting held from 23-27 April 2023 in New Orleans. Studies’ global coordinator, Dr. Andrew Schwartz (Fifth Avenue Eye Associates, NYC), presented a poster outlining the SVT-15473 clobetasol 0.05% ophthalmic nanoemulsion phase III clinical trial results for the treatment of inflammation and pain post-ocular surgery.
The presentation includes the pooled data of two successful phase III clinical trials of clobetasol, which were conducted between 2020 and 2021, testing more than 400 patients in over 40 specialized centers in the United States. The trials demonstrated the efficacy and safety of this innovative approach, with clobetasol proving effective in reducing inflammation and pain in post-ocular surgery patients. Read more about the clinical trials here.
Salvat Laboratories 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, a “superpotent” corticosteroid that had never been used before as eye drops. In addition to its efficacy and safety, clinical trials have shown that it has very low impact on intraocular pressure, unlike many other corticosteroids.
The exclusive nanoemulsion formulation (emulsion with drops of nanometric size) offers superior advantages over other established alternatives that are readily available, including better coverage of the ocular surface, more effective absorption, and no blurred vision or discomfort after application. After a standard 14-day course of treatment, the therapy has proven to have no rebound effect in the following 2 weeks, hence not requiring a gradual decrease in dosage towards the end of treatment.
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 Inc. in Miami (Florida), and at Salvat’s manufacturing site Pharmaloop S.L. in Alcala de Henares (Madrid).
The new drug is currently being reviewed by the US Food and Drug Administration (FDA), with approval expected in summer 2023. The submission of the NDA to the FDA is a significant step in the company’s strategy to position itself as one of the main players in the field of ophthalmology worldwide in the coming years.
Salvat Laboratories has invested over 20 million euros into this project, reinforcing its ophthalmology line as one of its main areas of research and development, aiming to improve people’s quality of life through innovation and the development of medicines and healthcare products with high-added value.