Positive interim RGX-314 data on RGX-314 for diabetic retinopathy announced

REGENXBIO Inc today announced additional positive interim data from the ongoing phase 2 ALTITUDE trial of RGX-314 for the treatment of diabetic retinopathy (DR) without center-involved diabetic macular edema (CI-DME) using in-office suprachoroidal delivery. The data were presented at the 55th Annual Retina Society meeting.

RGX-314 is being investigated as a potential one-time gene therapy for the treatment of wet age-related macular degeneration, DR, and other chronic retinal conditions.

“We are pleased with these positive interim results which demonstrate a clinically meaningful improvement in disease severity versus observational control, with more than 50% of patients dosed with RGX-314 in Cohorts 1-3 seeing improvement from baseline in their DRSS scores,” said Steve Pakola, MD, Chief Medical Officer of REGENXBIO in a press release. “RGX-314 continues to be well-tolerated across cohorts, and we look forward to the expansion of this trial to further evaluate the potential of RGX-314 for patients with DR.”

“I am encouraged by the positive results observed in the ALTITUDE trial of RGX-314,” said Dr Vajzovic. “A one-time, in-office injection of RGX-314 gene therapy could potentially provide critical improvement in DR severity and reduce the risk of vision threatening complications. Early intervention is key in slowing disease progression for DR patients, and RGX-314 has the potential to provide an important treatment option to address the current unmet need for these patients. I look forward to seeing additional results from Cohorts 4 and 5 of the ALTITUDE trial.”

Read the full press release here.