Major option for microinjector

ALPHARETTA, Ga.—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 recently that REGENXBIO Inc. had exercised its option under a previously announced option and license agreement to license Clearside’s proprietary, in-office SCS Microinjector for the delivery of adeno-associated virus (AAV)-based therapeutics. This is for uses including but not limited to RGX-314 delivery to the suprachoroidal space to potentially treat wet age-related macular degeneration (wet AMD), diabetic retinopathy and other conditions for which chronic anti-vascular endothelial growth factor (anti-VEGF) treatment is currently the standard of care.

“Our recent partnerships with REGENXBIO, Bausch Health and Aura Biosciences demonstrate the broad applicability of our suprachoroidal space injection platform to potentially treat multiple ocular diseases including wet AMD, uveitic macular edema and choroidal melanoma. With these collaborations and planned internal research and development efforts, we look forward to continuing to expand our pipeline,” said Dr. George Lasezkay, CEO of Clearside.

Under the terms of the agreement, Clearside earned $2 million related to REGENXBIO’s exercise of the option and signing of the original research agreement. Clearside is also eligible to receive up to $34 million in total development milestones across multiple indications, up to $102 million in sales milestones, and mid-single digit royalties on net sales of products using the SCS Microinjector. REGENXBIO will be responsible for all development, regulatory and commercialization activities for their gene therapy product candidates. Clearside will be responsible for supplying the SCS Microinjector in support of REGENXBIO’s preclinical studies, clinical studies and commercial use.

“Results from multiple preclinical studies support the potential safety and effectiveness of suprachoroidally administered AAV-based gene therapy, and we are excited to advance our partnership with REGENXBIO,” stated Dr. Thomas A. Ciulla, chief medical officer of Clearside. “Wet AMD and diabetic retinopathy are the two most common causes of irreversible blindness in the United States, and several large ‘real-world’ studies reveal under-treatment and outcomes that fall short of those reported in clinical trials. Utilizing our SCS Microinjector, delivery of RGX-314 may provide patients with access to one-time gene therapy treatment in a range of patient care settings.”