Resubmission of Xipere new drug application delayed
The resubmission of Clearside Biomedical’s new drug application for Xipere has been delayed, the company said in a press release.
Clearside said the contract manufacturing organization for Xipere (triamcinolone acetonide suprachoroidal injectable suspension), a potential treatment for macular edema associated with uveitis, is undergoing requalification activities in its facility, and even though the activities are not related to Xipere, they are affecting its production timing. In addition, challenges related to the COVID-19 pandemic have affected work schedules. The NDA is now expected to be resubmitted in the fourth quarter of this year.
Clearside also announced that Bausch + Lomb, which previously acquired a license to commercialize and develop Xipere in the United States and Canada, has been granted exclusive options to commercialize and develop Xipere in Europe, the United Kingdom, Australia, New Zealand, South America and Mexico. Bausch + Lomb also extended the time Clearside has to obtain U.S. approval for Xipere.
“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 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,” George Lasezkay, PharmD, JD, president and CEO of Clearside, said in the release.