LAVAL, QC and ALPHARETTA, Ga., Oct. 25, 2021
Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health"), and Clearside Biomedical, Inc. (Nasdaq: CLSD) ("Clearside"), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today announced that the U.S. Food and Drug Administration (FDA) has approved XIPERE™ (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation.
The clinical program for XIPERE™ included the pivotal Phase 3 trial (PEACHTREE), a Phase 3, multi-center, non-interventional extension study (MAGNOLIA), and an open-label safety trial (AZALEA).
The FDA approval of XIPERE™ was based on results from PEACHTREE, a randomized, multicenter, double-masked, sham-controlled Phase 3 clinical trial of 160 patients with macular edema associated with uveitis. XIPERE™ is the first and only uveitic macular edema treatment to demonstrate clinical efficacy with a BCVA (Best Corrected Visual Acuity) primary endpoint.
The primary efficacy endpoint was the proportion of patients in whom BCVA had improved by at least 15 letters from baseline after 24 weeks of follow-up. In the trial, a statistically significantly greater proportion of patients treated with XIPERE™ (47%) achieved at least a 15-letter improvement in BCVA than patients in the control arm (16%, p< 0.01) at Week 24.
The most common adverse reactions reported by greater than or equal to 10% of patients and at a rate greater than control included elevated intraocular pressure and eye pain.
Macular edema is the buildup of fluid in the macula, which causes retinal swelling and distorted vision, and if left untreated, may lead to permanent vision loss3. XIPERE™ is designed to treat macular edema associated with uveitis via suprachoroidal administration using the proprietary SCS Microinjector® developed by Clearside. Suprachoroidal administration is an innovative technique for delivering ocular therapies that may facilitate more targeted delivery of therapeutic agents to the retina and choroid.
The SCS Microinjector® offers unique access to the back of the eye where sight-threatening disease often occurs. It is designed to provide targeted and compartmentalized delivery and higher proportions of absorption relative to intravitreal injection (IVT). Targeted drug delivery via the suprachoroidal space (SCS®) may also limit corticosteroid exposure to the anterior segment with the potential to reduce the risk of certain adverse events, such as cataracts, intraocular pressure elevation and exacerbation of glaucoma, that are commonly associated with local delivery techniques.