The option and licensing deal is potentially worth more than $130 million, the companies said.
The SCS microinjector is designed to deliver adeno-associated virus (AAV) gene therapies to treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other conditions. The deal would also give Regenxbio rights to sublicense sales of Clearside’s microinjector. Once Regenxbio exercises the option, Clearside will receive a fee, plus up to $34 million in total development milestones and up to $102 million in sales milestones, according to a news release.
The agreement also makes Regenxbio responsible for development and commercialization activities for gene therapy product candidates, while Clearside is responsible for supplying the microinjector and supporting Regenxbio’s preclinical studies, clinical studies and commercial use.
Alpharetta, Ga.-based Clearside Biomedical’s 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.
Rockville, Md.-based Regenxbio plans to evaluate its RGX-314 delivery system using the microinjector for in-office, non-surgical delivery to the suprachoroidal space, while continuing to advance its RGX-314 delivery program in development for wet AMD and DR.
“We are pleased to partner with Clearside in evaluating the use of the SCS microinjector to deliver RGX-314 to the suprachoroidal space in the eye,” said Regenxbio president & CEO Kenneth Mills. “We believe this approach can potentially allow for the treatment of an expanded population of patients with wet AMD and DR by providing access to gene therapy treatment in all settings of patient care.
“We will continue to advance the RGX-314 subretinal delivery clinical program, with a Phase IIb clinical trial in wet AMD and a Phase II clinical trial in DR expected to begin by the end of 2019,” Mills added. “We look forward to moving both delivery approaches through development as part of our deep commitment to patients.”
“Regenxbio is the ideal partner for us given its leadership, expertise and pioneering work in the development and manufacturing of AAV vectors for the delivery of anti-VEGF therapeutic antibodies in the ophthalmology space,” added Clearside Biomedical CEO George Lasezkay. “We are excited by the recent positive interim data reported by Regenxbio from the current RGX-314 Phase I/IIa trial in wet AMD. This is an exciting time for us to collaborate with Regenxbio to evaluate the potential application of our proprietary in-office SCS microinjector for AAV gene therapy.”
Shares of CLSD were down -7.3% to $0.63 in mid-afternoon trading today. RGNX shares closed down -0.64% today, at $32.76 per share.