The Company’s product pipeline strategy focuses on applying the Verisome technology to approved and/or in-market ophthalmic agents, thus significantly reducing drug development risk while providing opportunities to take advantage of the comparatively more speedy 505(b)(2) regulatory approval pathways. Additionally, our broad product pipeline interests target unmet or under-satisfied needs of essentially all major ophthalmic pharmaceutical markets.
Icon’s lead pipeline product, Dexycu for the treatment of inflammation associated with cataract surgery has completed phase III and an NDA is planned for 2017. Several other drug candidates are at various stages of development, including IBI-60089 for glaucoma and a second-generation cataract inflammation/antibiotic product. Additionally, in November, 2012 the Company received FDA approval for Orphan Drug Designation of IBI-80090 (melphalan for intraocular injection) for the treatment of retinoblastoma. We will be collaborating with Memorial Sloan Kettering Cancer Center on that project.