Bausch Health has acquired an exclusive license for Clearside Biomedical’s Xipere, according to a press release.
Xipere (triamcinolone acetonide suprachoroidal injectable suspension) is designed to be administered using Clearside’s proprietary SCS microinjector for the treatment of macular edema associated with uveitis.
Under the terms of the licensing agreement, Bausch Health will pay up to $20 million to Clearside before launch, including an upfront payment upon signing, as well as additional payments based on sales-based milestones and regulatory approvals for additional indications, the release said.
Clearside expects to resubmit a new drug application for Xipere to the FDA in the first quarter of 2020.
“Bausch Health is committed to continuing our pivot to offense by augmenting our pipeline with investigational treatments like Xipere, which we believe will complement our Bausch + Lomb portfolio of integrated eye health products,” Joseph C. Papa, chairman and CEO, Bausch Health, said in the release. “If approved by the FDA, Xipere will be the first therapy available for patients suffering from macular edema associated with uveitis.”
Bausch Health will also gain the right to pursue development and commercialization of the drug for additional ophthalmic indications, along with the right to develop and commercialize Clearside’s microinjector for use with certain corticosteroids and NSAIDs, in the U.S. and Canada.