Clearside Biomedical partner, Artic Vision, reports positive topline results from phase 3 ARCATUS trial
The results from the trial in China met both the primary and secondary endpoints with no serious adverse events or new safety signals.
(Image credit: AdobeStock/Jasmin Merdan)
Clearside Biomedical, Inc. shared that partner, Arctic Vision, has reported positive topline results from its Phase 3 clinical trial of ARCATUS (ARVN001) for the treatment of uveitic macular edema (UME) in China.
The therapeutic is a triamcinolone acetonide injectable suspension for suprachoroidal use, which was originally developed by Clearside under the name XIPERE. Arctic Vision, based in China, has the exclusive license for the commercialization and development of XIPERE® in Greater China, South Korea, Australia, New Zealand, India, and the ASEAN Countries. ARCATUS is Arctic Vision’s name for XIPERE.
The results from the phase 3 trial met the primary endpoint and secondary endpoints, with significantly better visual acuity improvement and edema control in the treatment arm over the sham arm. In the study, 38.5% of ARVN001-treated patients gained 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or more in vision vs 9.4% in the sham group. ARVN001-treated patients had a central subfield thickness (CST) reduction of 204.3 microns vs 1.6 microns in the sham group at week 24. Both reached statistical significance (p<0.001).
In addition to these results, Artic Vision reported that the mean best corrected visual acuity (BCVA) gain was 9.6 letters at week 4 and 12.2 letters at week 24. The CST changes achieved over 200 microns reduction at week 4 and maintained the reduction to week 24. No ocular serious adverse events (SAEs) or new safety signals were reported.
George Lasezkay, PharmD, JD, is the President and Chief Executive Officer of Clearside Biomedical. In the company’s press release, he noted that this development further expands this the potential for global use of the pharmaceutical, saying, “This new, positive Phase 3 data from Arctic Vision reinforces the global product opportunity of XIPERE as a key treatment option for patients with uveitic macular edema. XIPERE was our first FDA-approved product and has led the way for our proprietary suprachoroidal space injection treatment approach that offers unprecedented access to the back of the eye, where sight-threatening disease occurs. Our partner, Arctic Vision, is making excellent progress in bringing this important therapy to market in the Asia-Pacific region.”
In addition to the positive topline results for this therapeutic, Arctic Vision announced that new drug applications (NDAs) for ARCATUS have been officially accepted in Australia and Singapore.
