- Phase III clinical trials conducted in adults confirm the efficacy and excellent safety profile of SVT-15473 ophthalmic clobetasol, formulated with IMPACT-SVT® patented nanoemulsion technology, for the treatment of inflammation and pain following ocular surgery.
- This is the first clinical study conducted in Europe in pediatric patients with a topical ophthalmic corticosteroid.
- With the new study, which is being carried out in six Spanish hospitals, its safety in pediatric patients aged 0 to 3 years is expected to be also demonstrated.
- With this project, which has involved a total investment of over 20 million euros, Salvat Laboratories takes another step in its strategy to establish itself as a key international player in the field of ophthalmology.
Salvat, an international laboratory that develops, manufactures, and markets products such as Cristalmina®, Gama Relive®, Tebarat®, and Cetraxal® Plus, has initiated a new study with SVT-15473 clobetasol, the first ocular corticosteroid formulated with IMPACT-SVT® patented nanoemulsion technology, to treat inflammation and pain in patients undergoing ocular surgery. In this case, the trial will include children aged 0 to 3 years with cataracts, aiming to demonstrate the drug’s safety in this population as well.
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 new 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 already 4 patients included and treated.
The conduct of this new study was agreed upon with the Food and Drug Administration (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,” explains Enrique Jiménez, Medical Director of Salvat Laboratories.
Innovation in the Industry
Salvat has developed IMPACT-SVT®, a patented nanoemulsion technology (emulsion with nanometer-sized droplets) for drug administration, promoting its penetration and accelerating the onset of its action, while providing excellent ocular comfort. IMPACT-SVT® has enabled the development of SVT-15473 using clobetasol, a “superpotent” corticosteroid that has never been used in the form of eye drops before.
Manufactured with BFS (Blow-Fill-Seal) technology, a sterile, advanced, and automated single-dose vial manufacturing system, SVT-15473 will be produced in the manufacturing line of Salvat USA Inc. in Miami, Florida, and in Pharmaloop S.L., Salvat’s facility in Alcalá de Henares, Madrid.
With this project, which has involved a total investment of over 20 million euros, Salvat Laboratories takes another step in its strategy to establish itself as a key international player in the field of ophthalmology.