- The US FDA has determined that Clearside’s application has attained a sufficient level of completion to warrant a substantive review.
- The company’s NDA filing was supported by the data from the company’s Phase 3 clinical trial.
Clearside Biomedical, Inc., (Clearside), a renowned American biopharmaceutical company, has reportedly announced that its New Drug Application (NDA) filing for XIPERE (Triamcinolone Acetonide Ophthalmic Suspension) has been accepted by the United States FDA for review.
Reports cite, the XIPERE review would be for a Suprachoroidal injection that has been developed for treating macular edema that is associated with uveitis. Clearside’s application was accepted after the FDA determined that has attained a sufficient level of completion to warrant a substantive review.
According to a press release by Clearside Biomedical, the company’s NDA filing was supported by the data from the company’s Phase 3 clinical trial, PEACHTREE, that showcased clinically meaningful & significant improvement in the overall vision for individuals suffering from macular edema that is associated with a rare eye-condition called non-infectious uveitis.
The President & Chief Executive Officer of Daniel H. White stated that the company is thrilled with the FDA’s decision. If approved, XIPERE would be Clearside’s first therapy that is designed for people suffering with macular edema that is linked to uveitis. White further stated that macular edema is the primary cause behind vision loss & even blindness in patients. With the FDA’s acceptance of the NDA brings the company one step closer to treat this underserved demographic.
The clinical trials reportedly showed that the vision improvement witnessed in the clinical trial was attained across all of the uveitis’ anatomical locations. Moreover, in individuals with inflammation at the baseline, a resolution was achieved on approximately two-thirds of the people treated with the drug.
According to reports, the FDA’s PDUFA (Prescription Drug User Fee Act) date has been scheduled for October 19 this year.