Cristalmina® - Topical antiseptic

• Los ensayos clínicos fase III realizados en adultos confirman la eficacia y el excelente perfil de seguridad de SVT-15473 clobetasol oftálmico, formulado con IMPACT-SVT® tecnología patentada de nanoemulsiones, para el tratamiento de la inflamación y el dolor después de una cirugía ocular.
• Es el primer estudio clínico que se realiza en paciente pediátrico con un corticoide tópico oftálmico en toda Europa.
• Con el nuevo estudio que se inicia ahora y que se llevará a cabo en seis hospitales españoles se espera demostrar también su seguridad en pacientes pediátricos de 0 a 3 años.
• Con este proyecto, que ha supuesto una inversión global de más de 20 millones de euros, Laboratorios Salvat da un paso más en su estrategia de afianzarse como un actor clave en el área de oftalmología a nivel internacional.

Salvat has developed IMPACT-SVT®, a patented nanoemulsion drug delivery technology that improves drug mucus penetration and bio-adhesion, providing excellent ocular comfort.

IMPACT-SVT® made it possible to develop SVT-15473, using the strongest corticosteroid in the global market.

Salvat Laboratories, 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. 

• The new drug will be the only one on the market in the United States and Europe specifically formulated and indicated for the topical treatment of fungal otitis externa.

• Salvat has invested 22 million euros in this project with which reinforces its position as a leading laboratory in the field of otology at an international level. 

 

Salvat offers an integrated end-to-end solution to ensure your project’s commercial success. We offer the latest technologies with optimum quality, flexibility and operational excellence. With over 70 years of experience, we can provide the services and solutions that make our partners successful.

Salvat Laboratories, the international company, which developed and owns the globally commercialized products Otovel and Cetraxal, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of the first ocular corticosteroid formulated in a nanoemulsion for inflammation and pain in post-ocular surgery patients.

Sharing a commitment to patients worldwide

LICENSING-OUT our products focus on Ophthalmology, Otorhinolaryngology, Gastroenterology & Consumer Health Care.

LICENSING-IN products for the Spanish, Portuguese, African and Central American markets. Our areas of interest are in Rx products in ophthalmology, otorhinolaryngology, and gastroenterology.

The new 8,500 m² plant is equipped with the most advanced technology, highest quality standards and the capacity to produce more than 350 million units of sterile formulations per year.

Over 60 years of experience in the pharmaceutical industry Salvat offers complete CDMO services.Expertise in Blow-Fill-Seal technology, single-dose vials
Manufacturing sites located in Barcelona, Madrid & Miami

The aim of these trials, which began in 2020, is to prove the efficacy of this innovative drug in treating ocular inflammation and pain after cataract surgery. For the first time in the world, this new product will use nanoparticles applied to the eye in order to help the drug’s absorption and application.