Clearside Biomedical received a complete response letter (CRL) from the FDA for its macular edema drug candidate over the need for additional stability data.
The agency didn’t raise any efficacy concerns over the potential treatment, Xipere (triamcinolone acetonide suprachoroidal injectable suspension), but called for additional stability data and for reinspection of the medicine’s manufacturer, the Alpharetta, Georgia drugmaker explained in a filing with the Securities and Exchange Commission.
The agency also wants additional data on the clinical use of the microinjector device that will be used to administer the drug and requested that the use assessment be conducted by at least three physicians in 30 patients.
The drugmaker said it believes that the issues in the CRL “can be addressed in a timely manner” to enable the company to resubmit the NDA in the first quarter of 2020. It added that it will be asking the agency to meet and discuss its plans for tackling the concerns.