RGNX Clinical trials

REGENXBIO Announces Pivotal Program for Surabgene Lomparvovec in Diabetic Retinopathy

Published August 07, 2025 at 11:00 AM

A pivotal Phase IIb/III clinical trial using suprachoroidal delivery for treatment of diabetic retinopathy will be initiated New Phase II ALTITUDE® trial data demonstrate a durable safety and efficacy profile observed through two years with a single, in-office injection of surabgene...

Related Questions

How does the suprachoroidal delivery platform differentiate RGNX from other gene‑therapy companies pursuing ocular indications? What is the likely impact on RGNX's valuation multiples (e.g., EV/Revenue, P/E) if the trial meets its primary endpoints? How does the safety and efficacy data from the Phase II ALTITUDE® trial compare with competitor programs in the same indication? What are the potential upside and downside scenarios for RGNX based on the upcoming pivotal trial outcomes? Will the single‑in‑office injection format provide a competitive advantage in terms of adoption and reimbursement? What regulatory timeline is expected for surabgene Lomparvovec, and how might that influence analyst consensus and price targets? How might the trial results impact RGNX's cash burn and need for additional financing or partnership deals? How will the initiation of the pivotal Phase IIb/III trial for surabgene Lomparvovec affect RGNX's near‑term stock price? What are the projected market size and revenue potential for a suprachoroidal therapy targeting diabetic retinopathy compared to existing treatments? What are the potential risks that could delay or derail the pivotal trial, such as enrollment challenges or adverse events?