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 complies with the 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 an 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 a phase II/III clinical trial in Taiwan.