Adverum Biotechnologies announces new data from OPTIC Phase 1 trial

By Pankaj Singh

Adverum Biotechnologies, a California based biotech company, has reportedly announced new clinical data from the OPTIC Phase 1 with dose ranging clinical stage trial of gene therapy intravitreal injection namely ADVM-022.

The OPTIC trial has enrolled patients that are experienced in treatment with wet AMD (age-related macular degeneration). The data is being presented by David S. Boyer, M.D., Retina-Vitreous Associates Medical Group senior partner and assistant clinical ophthalmology professor at the University of Southern California in Los Angeles, at the 2020 Angiogenesis, Exudation, and Degeneration conference held in Miami.

The data is being presented, for the very first time from patients in group 2 at 24 weeks after treatment from a single intravitreal injection that is of a 3-fold lower dosage of ADVM-022 in comparison to the group 1 dose.

David S. Boyer stated that ADVM continues to be well tolerated and safe, with ocular inflammation which is controllable with steroid eye drops. Patients with their caregivers and wet AMD carry a substantial burden of treatment from the existing standard of care anti Vascular endothelial growth factor (VEGF) injections, and real-life vision results are substandard due to undertreatment. ADVM-022 as intravitreal injection therapy that is one-time only could significantly transform the paradigm of treatment for patients as well as their caregivers.

Aaron Osborne, MBBS, CMO, Adverum, stated that ADVM-022 has exhibited evidence of a dose response and robust efficacy signal in the OPTIC phase 1 clinical trial with data from 12 patients and two doses that are now available. Patients in group 2 were administered a 3-fold lower dosage of ADVM-022 than in group 1, and 4 of 6 of the patients are injection-free throughout 24 weeks, whereas all 6 patients that are in group 1 remained rescue free with a median follow up of 50 weeks.

Osborne further stated that OPTIC is growing well, with key goals for group 3 and 4 to assess dose response and evaluate a 6-week course of prophylactic of steroid eyedrops instead of oral steroid prophylaxis that is of 13-day used in groups 1 and 2. The company is looking forward to present clinical data from all four groups of OPTIC for the current year in the clinic for the company’s new gene therapy, ADVM-022.

Source credit: http://investors.adverum.com/news-releases/news-release-details/adverum-biotechnologies-reports-new-interim-data-cohorts-1-and-2