Clearside Biomedical Announces Clinical Data Presentations at The Retina Society 2020 and Publication of XIPERE Data in Diabetic Macular Edema in Ophthalmology Retina

Presented the most robust aggregate dataset of suprachoroidal clinical injections demonstrating reliability and consistency of procedure

ALPHARETTA, Ga., Sept. 23, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today several clinical data presentations were given at the virtual 53rd Annual Scientific Meeting of The Retina Society.

Clearside also announced that data from the Company’s Phase 2 clinical trial in diabetic macular edema (DME) was published in Ophthalmology Retina and can be accessed here. The trial, entitled TYBEE, evaluated the investigational drug XIPERE (triamcinolone acetonide suprachoroidal injectable suspension) when used with intravitreally administered aflibercept in patients with DME over a 6-month evaluation period. This early data suggests that, if approved, XIPERE administered suprachoroidally, may have the potential to reduce treatment burden for some patients.

“Our primary goal at Clearside is to deliver targeted treatments for patients suffering from serious retinal diseases,” said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. “We are committed to educating physicians and the broader retinal community on our programs. The presentations delivered this week and the publication of our work in DME underscore the broad scope of development activities for our suprachoroidal injection platform. We continue to expand our pipeline with new opportunities and indications and look forward to starting our Phase 1/2a clinical trial with CLS-AX in neovascular age-related macular degeneration (wet AMD) this year.”

Title: Suprachoroidal CLS-AX (axitinib injectable suspension), as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (nAMD)
Authors: David Brown; Viral Kansara; Thomas Ciulla
Conclusions: CLS-AX was observed to be well tolerated in all animal species evaluated, with no overt signs of toxicity. There was sustained, high exposure observed in ocular tissues with the highest concentration found in the tissues of the sclera, choroid, and retinal pigment epithelium (RPE), followed by the retina. CLS-AX has intrinsic high potency, pan-VEGF inhibition through receptor blockade, and demonstrated prolonged duration observed in pharmacokinetic studies, as well as pharmacodynamic effect in multiple animal models. CLS-AX is intended to be a targeted therapy to affected tissue layers via suprachoroidal injection and has the potential to be a bi-annual therapy for wet AMD.