Clearside Biomedical announced completion of patient enrollment in a phase 3 clinical trial of suprachoroidal CLS-TA used in combination with intravitreally administered Eylea (aflibercept) for the treatment of retinal vein occlusion (RVO).
SAPPHIRE, a multicenter, multi-country, randomized, masked, controlled phase 3 clinical trial, has enrolled 460 patients who are naïve to pharmacologic treatment for RVO. The SAPPHIRE study will assess whether using suprachoroidal CLS-TA in combination with intravitreal Eylea may offer an opportunity for earlier improved visual outcomes for RVO patients compared to Eylea monotherapy, and is also designed to evaluate required treatment frequency for the combination arm compared to the Eylea-alone control arm over the course of the trial.
“We expect to report topline 8-week primary endpoint data from the SAPPHIRE trial in the fourth quarter of 2018,” Daniel H. White, Chief Executive Officer and President of Clearside, said in a company news release. “In the previously completed phase 2 TANZANITE trial in RVO, suprachoroidal CLS-TA used with intravitreal Eylea showed the potential to provide better vision, faster onset of action and a longer duration of action than treatment with intravitreal Eylea alone. In TANZANITE, 61% of patients in the combination arm gained at least 15 ETDRS letters, or three lines of vision, at 8 weeks, compared to 39% of patients in the control arm. Based on the observations from the TANZANITE trial, we believe the SAPPHIRE study has the potential to show that using suprachoroidal CLS-TA with an intravitreal anti-VEGF agent may offer an opportunity for both improved visual outcomes and a reduced treatment burden for RVO patients.”
More details about Clearside’s RVO clinical development program are available via the company’s current corporate presentation, which can be accessed at http://ir.clearsidebio.com/events-and-presentations.