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Regenxbio pulls trigger on option to license Clearside Biomedical’s SCS Microinjector

October 31, 2019 By Sean Whooley

Clearside Biomedical logo - updatedClearside Biomedical (NSDQ:CLSD) said yesterday that Regenxbio (NSDQ:RGNX) exercised its option to license Clearside’s in-office SCS Microinjector for delivering adeno-associated virus (AAV)-based therapeutics in treating wet age-related macular degeneration, diabetic retinopathy and other conditions.

The two companies inked the option and licensing deal that they said at the time could be worth more than $130 million on Sept. 5. Under the agreement, Clearside earned $2 million after Regenxbio pulled the trigger on the option.

Alpharetta, Ga.-based Clearside is eligible to pick up as much as $34 million in development milestones across multiple indications and up to $102 million in sales milestones, along with mid-single digit royalties on net sales of products using the SCS Microinjector.

Under the agreement, Regenxbio is responsible for development, regulatory and commercialization activities for its gene therapy product candidates, while Clearside is required to supply the microinjector for Regenxbio’s preclinical studies, clinical studies and commercial use.

The proprietary, in-office SCS Microinjector is designed to deliver Regenxbio’s RGX-314 to the suprachoroidal space of the eye to treat wet AMD, DR and other conditions for which anti-vascular endothelial growth factor (anti-VEGF) treatment is the current standard care.

Clearside licensed the microinjector to Aura Biosciences on July 9 and inked a deal with Bausch Health last week for its Xipere device for the treatment of macular edema associated with uveitis.

“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,” Clearside CEO George Lasezkay said in prepared remarks. “With these collaborations and planned internal research and development efforts, we look forward to continuing to expand our pipeline.”

“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,” added Clearside chief medical officer Dr. Thomas Ciulla. “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.”

Shares of RGNX were up 1.6% at $35.09 per share, while shares of CLSD were down -3.3% at $1.16 per share in midday trading today.

Filed Under: Auto-injectors, Business/Financial News, Drug-Device Combinations, Featured, Optical/Ophthalmic Tagged With: Clearside Biomedical, Regenxbio

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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