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Pivotal Phase 3 Data On Xipere™

Bausch + Lomb and its parent company, Bausch Health Companies Inc., and Clearside Biomedical, Inc, a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced that Ophthalmology, the peer-reviewed journal of the American Academy of Ophthalmology, has published results from the randomized, controlled, double-masked Phase 3 clinical trial (PEACHTREE study) of XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension), an investigational treatment with a proposed indication of macular edema associated with uveitis.

“Macular edema is the leading cause of vision loss in patients with uveitis,” said Steven Yeh, M.D., lead author and principal investigator for the PEACHTREE study, and M. Louise Simpson Associate professor of ophthalmology, Emory Eye Center. “The efficacy and safety data from the PEACHTREE Phase 3 trial showed that delivery of XIPERE via suprachoroidal administration, an alternative technique for delivering ocular therapies, may facilitate more targeted delivery of therapeutic agents to the retina and choroid. Targeted drug delivery via the suprachoroidal space may also limit corticosteroid exposure to the anterior segment with the potential to decrease adverse events, such as cataracts, intraocular pressure elevation and exacerbation of glaucoma, that can commonly arise from other local corticosteroid delivery techniques.”

The data demonstrated that patients with noninfectious uveitis in the XIPERE study arm experienced clinically significant improvement in vision relative to the control arm, demonstrating the potential efficacy of suprachoroidal injection of XIPERE for the treatment of macular edema associated with uveitis. No serious adverse events (AEs) considered by the investigators related to treatment were reported.

“The publication of our positive Phase 3 XIPERE clinical trial results is an important milestone for Clearside as it expands the understanding of our suprachoroidal treatment approach,” said Thomas A. Ciulla, M.D., MBA, chief medical officer, Clearside Medical. “We are coordinating closely with Bausch Health, our exclusive licensee of XIPERE in the United States and Canada, and are excited for the potential to add this treatment option to the repertoire for retinal specialists.”

“The results of this study are an exciting development in our journey with Clearside to bring patients this potential new treatment option, if approved,” said Yolande Barnard, vice president and general manager, U.S. Pharmaceuticals, Bausch + Lomb. “We are committed to delivering therapies that can make a difference in patients’ vision and lives, and our work with XIPERE is a strong example of that.”

About the Phase 3 PEACHTREE Study

The PEACHTREE study was a randomized, controlled, masked, Phase 3 clinical trial that evaluated the safety and efficacy of XIPERE in 160 patients with macular edema associated with noninfectious uveitis. Patients were randomized to receive XIPERE at baseline and at 12 weeks versus control. The PEACHTREE study met its primary endpoint, with 47 percent of patients in the XIPERE arm gaining at least 15 letters in best corrected visual acuity from baseline at week 24, compared to 16 percent of patients in the control arm (p<0.001), using the standardized Early Treatment of Diabetic Retinopathy Study scale (visual acuity testing). All key secondary and additional endpoints of the PEACHTREE study were also achieved. No serious AEs considered by the investigators to be related to treatment were reported. Corticosteroid-associated AEs of elevated intraocular pressure occurred in 11.5% and 15.6% of the XIPERE and control groups, respectively. Cataract AE rates were comparable (7.3% and 6.3%, respectively)

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