Lux to develop corneal rejection prevention implant

Lux Biosciences has entered into an exclusive worldwide license agreement with the US National Institutes of Health (NIH) to acquire intellectual property rights for a cyclosporine A (CsA) eluting silicone matrix ocular implant, LX201. The candidate is to be tested for the prevention of rejection following corneal transplantation.

In addition to the agreement, the Commission of Orphan Medicinal Products (COMP) has recommended that LX201 receive European orphan drug designation. As a result of this, Lux expects to initiate pivotal trials in early 2007, with an estimated New Drug Application (NDA) submission scheduled for early 2009.

LX201 is a silicone matrix ocular implant that steadily releases therapeutic doses of CsA locally to the eye over the course of twelve months. CsA is already widely used as a systemic therapy for the prevention of organ rejection.

Local delivery of CsA through LX201 offers potentially significant benefits in the treatment of corneal transplantation because of the increased safety and efficacy associated with local administration, as well as enhanced patient compliance.