Bausch Health Companies announced that an affiliate of Bausch Health has acquired an exclusive license for the commercialization and development of Xipere (triamcinolone acetonide suprachoroidal injectable suspension) in the United States and Canada.
Xipere is a proprietary 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 new drug application (NDA) for Xipere to the FDA for review in the first quarter of 2020 and believes the FDA will review the NDA within 6 months of receipt of the resubmission.
“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 a company news release. “If approved by the FDA, Xipere will be the first therapy available for patients suffering from macular edema associated with uveitis.”
Under the terms of the agreement, Clearside will receive up to $20 million in payments prior to launch, including an upfront payment upon signing the agreement. 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 United States and Canada.
Bausch Health also has the right to pursue development and commercialization of Xipere for additional ophthalmic indications in the United States and Canada. Furthermore, Bausch Health has the right to develop and commercialize Clearside’s proprietary SCS Microinjector in combination with certain specified corticosteroids and NSAIDs in the United States and Canada for the field of ophthalmology.
“We believe that partnering with Bausch + Lomb will allow us to maximize Xipere’s commercial potential and provide broad accessibility for patients,” George Lasezkay, PharmD, JD, CEO of Clearside, said in the news release. “With an established and experienced ophthalmic sales force, we believe Bausch + Lomb can quickly and efficiently integrate Xipere into their commercial operations. We look forward to coordinating with the Bausch + Lomb team to gain regulatory approval and to share key learnings from our physician training program to help ensure a successful launch of Xipere in the United States and Canada.”