An affiliate of Bausch Health Companies (NYSE,TSX:BHC) has acquired an exclusive license for the commercialization and development of XIPERE in the U.S. and Canada from Clearside Biomedical (NASDAQ:CLSD).
XIPERE is a suspension of the corticosteroid, triamcinolone acetonide, formulated for suprachoroidal administration via Clearside’s proprietary SCS Microinjector that is being investigated as a targeted treatment of macular edema associated with uveitis.
Clearside expects to resubmit its NDA for XIPERE to the FDA in the first quarter of 2020 and believes the FDA will review the NDA within six months of the resubmission. If approved, XIPERE will be the first therapy available for patients suffering from macular edema associated with uveitis.
“We believe that partnering with Bausch + Lomb will allow us to maximize XIPERE’s commercial potential and provide broad accessibility for patients,” George Lasezkay, CEO of Clearside, said in a statement.
“With an established and experienced ophthalmic sales force, we believe Bausch + Lomb can quickly and efficiently integrate XIPERE into their commercial operations,” he added.
Under the accord, Clearside will receive up to $20-million in payments prior to launch. Clearside may receive additional payments based on certain sales-based milestones and regulatory approvals for additional indications of the XIPERE product. Clearside also will be entitled to receive tiered royalties based on annual net sales of XIPERE in the U.S. and Canada.
