Salvat Laboratories Initiates a Pediatric Study in Europe with SVT-15473 for the Treatment of Inflammation and Pain Following Ocular Surgery

Salvat Laboratories has initiated a new study with SVT-15473 clobetasol to treat inflammation and pain in patients undergoing ocular surgery. The trial will include children aged 0 to 3 years with cataracts, aiming to demonstrate the drug's safety in this population.

Cataracts in pediatric patients can be congenital or acquired as part of certain diseases. Overall, the incidence of pediatric cataracts ranges from 1 to 5 cases per 10,000 individuals. 

The study, which is the first to be conducted in Europe with topical corticosteroids in this pathology and population, will include 60 cases randomly divided into two equal groups. One group will be treated with SVT-15473, and the other, as a control group with Prednisolone. The study will take place in six Spanish hospitals, with coordination led by Dr. Marta Morales, Head of the Ophthalmology Department at Hospital Sant Joan de Déu in Barcelona. The participating hospitals include Vall d'Hebron Hospital and Germans Trias i Pujol Hospital, both in Barcelona; La Paz Hospital in Madrid; Cruces Hospital in Bilbao; and Miguel Servet Hospital in Zaragoza. Currently, there are 4 patients included and treated.

The new study was agreed upon with the FDA, as part of the approval process that has already been initiated based on the results of clinical trials involving 400 adult patients from 50 hospitals in the United States. These trials demonstrated the effectiveness and safety of SVT-15473 in treating inflammation and ocular pain following cataract surgery.

This new study, which aims to demonstrate the safety of SVT-15473 in patients aged 0 to 3 years, is complementary and does not interfere with the ongoing approval process, which is expected to conclude soon.

"Once we have completed this study in the pediatric population, the indication could be expanded to include this age group, allowing the use of SVT-15473 clobetasol in any patient, regardless of their age," Enrique Jiménez, Medical Director of Salvat Laboratories, said in a company news release.