SB04 is a conventional drug in new use, to treat patients with dry age-related macular degeneration (dry AMD). It is 505(b)(2) regulatory pathway eligible from the US FDA, and it also comply with Fast Track Pathway for IND in clinical trial Phase II/III. The Phase Ib/PoC of SB04 was completed in the US.
SB04 has many different mechanisms to treat patients without invasive way; even patient self-applied medication. The Phase II/III clinical trial of SB04 has been conducting from June 2012 in the U.S. In the meantime, its IND also approved by T-FDA in February, 2013, currently conducting phase II/III clinical trial in Taiwan.