Clearside Biomedical Inc CLSD shares — which came under intense selling pressure in late August after the company hinted at a possible FDA rejection of the NDA for its macular edema drug — got a reprieve Wednesday.
Clearside announced an option and license agreement with Regenxbio Inc RGNX, granting the latter worldwide rights to its proprietary in-office SCS Microinjector for the delivery of RGX-314 to the suprachoroidal space to treat wet age-related macular degeneration, or AMD; diabetic retinopathy, or DR; and other conditions for which anti-vascular endothelial growth factor treatment is currently the standard of care.
RGX-314 is a novel, one-time subretinal gene therapy being developed for wet AMD and DR. It includes the NAV AAV8 vector containing a gene encoding for a monoclonal antibody fragment.
The agreement provides for Clearside receiving a fee upon Regenxbio exercising its option, as well as 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.
Why It's Important
Delivery of NAV AAV8-based gene therapy through the suprachoroidal space, provides a targeted, in-office, non-surgical approach to obtain widespread transgene expression in retina, without having to expose the vitreous and anterior segment of the eye to the injected drug, according to the companies.
"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," Regenxbio CEO Kenneth Mills said in a statement.
Clearside shares were rallying by 51.96% to 89 cents at the time of publication Wednesday, while Regenxbio shares were up 0.51% at $33.48.
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