Regenxbio launches program for surabgene lomparvovec in diabetic retinopathy

Regenxbio (RGNX) will initiate a pivotal Phase IIb/III clinical trial for investigational surabgene lomparvovec – sura-vec, ABBV-RGX-314 – in diabetic retinopathy or DR, using suprachoroidal delivery and a corresponding amendment to its eyecare collaboration with AbbVie (ABBV). This clinical advancement follows new, positive two-year data from the Phase II ALTITUDE trial and long-term follow-up study, which enables the initiation of a global clinical program for DR. In the Phase II ALTITUDE trial, sura-vec was well tolerated in subjects with non-proliferative diabetic retinopathy at dose levels 1, 2, and 3. A pivotal two-part placebo-controlled Phase IIb/III trial will be initiated. Supported by the Phase II dose level 3 data, the primary endpoint will be greater than 2-step DRSS improvement at 1 year. Site selection is in progress. AbbVie and Regenxbio executed an amendment to the collaboration and license agreement established between the two companies on September 10, 2021. The amendment includes an updated milestone structure for the DR program, under the terms of which AbbVie will pay Regenxbio $100M upon first subject dosed in the Phase IIb/III trial and an additional $100M upon first subject dosed in a second Phase III clinical trial. Regenxbio will pay for all costs for Phase IIb of the Phase IIb/III trial. AbbVie will independently advance and pay all costs for a new Phase III ACHIEVE trial in wet AMD.