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Saturday, November 13, 2021

REGENXBIO: More Positive Interim Data on Wet AMD, Diabetic Retinopathy Trials

 

  • Suprachoroidal delivery of RGX-314 in Phase II AAVIATE® trial for the treatment of wet AMD continues to be well tolerated in 50 patients from Cohorts 1-3 with no drug-related serious adverse events

  • Positive initial data from Cohort 2 in AAVIATE trial at six months after one-time treatment of RGX-314

  • Additional data from Cohort 1 in Phase II ALTITUDE™ trial for the treatment of DR demonstrated stable visual acuity at three months after one-time treatment of RGX-314

REGENXBIO Inc. (Nasdaq: RGNX) today announced additional positive interim data from the ongoing Phase II AAVIATE® trial and the ongoing Phase II ALTITUDE™ trial of RGX-314 using in-office suprachoroidal delivery for the treatment of wet age-related macular degeneration (wet AMD) and diabetic retinopathy (DR) without center-involved diabetic macular edema (CI-DME), respectively. The results were presented at the American Academy of Ophthalmology (AAO) 2021 Annual Meeting by Robert L. Avery, M.D., Founder of California Retina Consultants and Research Foundation.

"We are pleased to share this initial data from Cohort 2 of the AAVIATE trial which provides encouraging evidence of the emerging clinical profile of RGX-314 for the treatment of wet AMD using suprachoroidal delivery. In the data reported today, RGX-314 was observed to be well tolerated in Cohort 2, with stable visual acuity and retinal thickness as well as a meaningful reduction in anti-VEGF treatment burden at six months," said Steve Pakola, M.D., Chief Medical Officer of REGENXBIO. "We look forward to providing additional updates from the program."

"These initial results from patients in Cohort 2 of the AAVIATE trial at six months after suprachoroidal administration of RGX-314 reinforce the potential impact that RGX-314 could have on the overall clinical management of patients with wet AMD," said Dr. Avery. "I am encouraged by the six-month data in Cohort 2 and look forward to reviewing further data from Cohorts 1-3 and from the higher dose level in Cohorts 4 and 5."

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