Steroid administration to change in next cohorts of Adverum’s OPTIC trial

Adverum Biotechnologies will change how patients receive steroids to manage inflammation in the third and fourth cohorts of its phase 1 OPTIC trial, the company announced in a press release.

The multicenter, open-label, dose-escalation OPTIC trial is assessing the safety and tolerability of a single injection of ADVM-022, a gene therapy candidate that uses a propriety vector capsid to deliver sustained therapeutic levels of aflibercept in patients with wet age-related macular degeneration.

In previous cohorts, patients received prophylactic oral steroids; however, in the third cohort, which began dosing in October 2019, and the upcoming fourth cohort, the trial will use prophylactic steroid eye drops, the release said.

“In 2019, we made significant progress advancing our lead gene therapy candidate ADVM-022 in the ongoing OPTIC phase 1 dose-ranging clinical trial in patients with wet age-related macular degeneration,” Leone Patterson, president and CEO of Adverum, said in the release. “This year, we look forward to presenting additional data from all four cohorts of patients in OPTIC. Additionally, we plan to submit an [investigational new drug application] for ADVM-022 in a second indication, diabetic retinopathy, and begin enrolling patients in a new clinical trial.”

The company recently presented 44-week data from the trial at the Atlantic Coast Retina Club and Macula 20/20 conference, showing patients in the first cohort achieved vision maintenance and improvements in retinal anatomy and did not require anti-VEGF rescue injections.

Adverum Biotechnologies will change how patients receive steroids to manage inflammation in the third and fourth cohorts of its phase 1 OPTIC trial, the company announced in a press release.

The multicenter, open-label, dose-escalation OPTIC trial is assessing the safety and tolerability of a single injection of ADVM-022, a gene therapy candidate that uses a propriety vector capsid to deliver sustained therapeutic levels of aflibercept in patients with wet age-related macular degeneration.

In previous cohorts, patients received prophylactic oral steroids; however, in the third cohort, which began dosing in October 2019, and the upcoming fourth cohort, the trial will use prophylactic steroid eye drops, the release said.

“In 2019, we made significant progress advancing our lead gene therapy candidate ADVM-022 in the ongoing OPTIC phase 1 dose-ranging clinical trial in patients with wet age-related macular degeneration,” Leone Patterson, president and CEO of Adverum, said in the release. “This year, we look forward to presenting additional data from all four cohorts of patients in OPTIC. Additionally, we plan to submit an [investigational new drug application] for ADVM-022 in a second indication, diabetic retinopathy, and begin enrolling patients in a new clinical trial.”

The company recently presented 44-week data from the trial at the Atlantic Coast Retina Club and Macula 20/20 conference, showing patients in the first cohort achieved vision maintenance and improvements in retinal anatomy and did not require anti-VEGF rescue injections.