Bausch Health Companies Inc. will acquire licensing rights to Clearside Biomedical Inc.'s investigational eye inflammation drug Xipere, which was rejected by the U.S. Food and Drug Administration on Oct. 21.
Xipere is being developed as a treatment for macular edema associated with uveitis, a condition in which fluid builds up in a part of the eye and leads to loss of vision.
Laval, Quebec-based Bausch will pay $5 million up front and up to $15 million in payments before the launch of Xipere, plus certain milestone payments thereafter.
Bausch said Clearside expects to resubmit the application for Xipere to the FDA in the first quarter of 2020.
Until the application is approved, Clearside will be responsible for all development expenses related to Xipere. Bausch will handle development expenses once the therapy is approved.
The FDA asked Clearside to provide additional stability data on the new manufacturing process for Xipere, an injectable form of a synthetic corticosteroid called triamcinolone acetonide.