Adverum Biotechnologies reports Q2 EPS (89c), consensus ($1.47)

“The LUNA trial was designed to answer a key question – whether lower doses of Ixo-vec with enhanced prophylactic regimens could demonstrate a product profile consistent with or better than that demonstrated in OPTIC. At ASRS, we presented LUNA interim analysis results that demonstrate we’ve achieved this objective and, further, that Ixo-vec at 6E10 with local prophylaxis represents a potential best-in-class product profile. Taken together, these results support our selection of the 6E10 dose for Phase 3 pivotal studies,” stated Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies. “Importantly, our development program builds on the long-term Ixo-vec results from the OPTIC study. In OPTIC, even with suboptimal prophylaxis, 14 of 15, or 93%, of 2E11 patients were free of inflammation at 1 year and 100% were inflammation free at 2 years after Ixo-vec treatment. When present, inflammation was successfully treated with topical corticosteroids. In LUNA, the analysis at the 26-week mark demonstrated an industry-leading proportion of patients free from injections, and there was an improved safety profile compared to OPTIC. In addition, we believe the LUNA pre-specified patient preference survey speaks to the overall best-in-class profile of Ixo-vec, with 93% of patients responding they would use Ixo-vec in their fellow eye. In the fourth quarter of this year, we look forward to presenting landmark 9-month data, as well as to providing updates on the design of our pivotal program.”