Vyome Biosciences’ IND application receives US FDA approval
The topical treatment will bring new option in the acne market with large unmet need.
15th Jan 2016. US Food and Drug Administration (US FDA) has accepted Vyome Biosciences’ Investigational New Drug (IND) application for the initiation of clinical studies for its lead programme VB 1953, a topical therapeutic candidate for the treatment of moderate-to-severe acne. Vyome plans to start the phase I clinical trials very soon.
“Today marks an important milestone for Vyome Biosciences. With US FDA accepting our first IND application for the lead programme VB 1953, we have become a clinical stage company in USA, which is an important value inflection milestone for us. This should pave way for further filings with the US FDA in future. VB 1953 is a first-in-class new product in acne therapy for addressing one of the very important and a large unmet need,” said N Venkat, Co-Founder and Chief Executive Officer, Vyome.