Bausch Health (NYSE:BHC) and Clearside Biomedical (NSDQ:CLSD) announced today that the FDA accepted their resubmitted new drug application for Xipere.
Clearside Biomedical designed the investigational Xipere triamcinolone acetonide suprachoroidal injectable suspension therapy with a proposed indication for treating macular edema associated with uveitis. Xipere works with Clearside’s proprietary SCS Microinjector to access the back of the eye where sight-threatening disease occurs.
In October 2019, the two companies inked a licensing deal worth up to $76 million. The agreement grants Bausch an exclusive license to develop, manufacture, distribute, promote, market and commercialize the suprachoroidal injection device.
Bausch agreed to pay $5 million upfront, plus additional payments worth up to $15 million after achieving specified pre-launch development and regulatory milestones. There’s another $56 million on the line in other milestone payments pegged to regulatory approvals for additional indications and sales goals.
In accepting the new drug application (NDA) for Xipere, the FDA determined that the filing is a Class 2 resubmission and assigned it a Prescription Drug User Fee Act (PDUFA) action date of Oct. 30, 2021.
“The FDA’s filing acceptance for Xipere is an exciting milestone for our collaboration with Clearside,” Bausch Health CEO Joseph C. Papa said in the release. “If approved by the FDA, Xipere would be the first therapy available utilizing the suprachoroidal space for patients suffering from macular edema associated with uveitis, which is the leading cause of vision loss in people with uveitis. With this acceptance, we are one step closer to providing an important novel treatment option for this patient population.”
Clearside president & CEO George Lasezkay thinks Xipere has the potential to advance the care of people suffering from macular edema with uveitis. “If approved, Xipere would be our first commercial product and the first approved drug to be delivered into the suprachoroidal space (SCS).”