04.28.20

Clearside Biomedical Revises NDA Resubmission Timeline and Xipere Commercial Partnership with Bausch Health

Source: Clearside Biomedical

Clearside Biomedical announced an update to the Xipere (triamcinolone acetonide suprachoroidal injectable suspension) new drug application (NDA) resubmission timeline and to its commercialization and development partnership with Bausch Health Companies and Bausch + Lomb.

As previously disclosed, the contract manufacturing organization (CMO) for Xipere has been completing certain requalification activities within its facility. While these manufacturing activities are not specifically related to Xipere, the CMO has advised Clearside that they continue to impact the timing of its production. Although extensive progress has been made, the CMO needs to resolve a final step affecting the proper functioning of its filling line equipment in order to produce the required stability batches to generate the data necessary for the Xipere NDA resubmission. As a result, and due in part to COVID-19 related challenges that have impacted work schedules, the CMO has informed Clearside that there will be a delay in completing the necessary corrective action. Based on this current information, Clearside now expects to resubmit the Xipere NDA in the fourth quarter of 2020.

In conjunction with this update, Clearside and Bausch Health have amended and revised their partnership for Xipere. Bausch + Lomb acquired an exclusive license in October 2019 for the commercialization and development of Xipere in the United States and Canada. Bausch + Lomb has now been granted exclusive options for the right to commercialize and develop Xipere in (i) Europe and the United Kingdom, (ii) Australia and New Zealand, and (iii) South America and Mexico. In the amended agreement, Bausch + Lomb has extended the time allowed for Clearside to obtain Xipere approval in the United States.

“We remain firmly committed to receiving approval from the U.S. Food and Drug Administration for Xipere as a potential treatment option for patients suffering from macular edema associated with uveitis,” George Lasezkay, PharmD, JD, Clearside’s President and Chief Executive Officer, said in a company news release. “We have been working collaboratively with Bausch Health throughout this process and they have proven to be the ideal partner. We are pleased that their continued support of Xipere and their interest in our suprachoroidal space (SCS) injection platform has resulted in an opportunity to expand our relationship to maximize the commercial potential for Xipere in additional important territories around the world.”

“Our other pipeline programs and external collaborations are not impacted by this timing, as there are separate CMOs for the SCS Microinjector, CLS-AX (axitinib injectable suspension), and other compounds to be used in various clinical trials by our partners. We remain on track to submit an investigational new drug (IND) application in mid-2020 for CLS-AX in wet age-related macular degeneration, which would potentially enable us to initiate a phase 1/2a clinical trial before the end of this year. We also expect a number of IND submissions in 2020 from our clinical development partners in gene therapy and ocular cancer utilizing our SCS Microinjector,” concluded Dr. Lasezkay.

As of March 31, 2020, Clearside’s cash and cash equivalents totaled $20.9 million. Based on Clearside’s current research and development plans and expected near-term partnership milestone payments, Clearside believes it will have sufficient resources to fund its planned operations into the second quarter of 2021. Detailed financial results for the quarter will be reported via a press release on May 8, 2020.

 

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