Adverum Biotechnologies Presents Long-term Data through March 10, 2021 from the OPTIC Trial of ADVM-022 Intravitreal Gene Therapy in Treatment-experienced Wet AMD Patients at ARVO 2021
-- Long-term durability and maintained efficacy; sustained robust aflibercept protein expression observed --
-- 60% of patients injection free beyond 1 year following 2 x 10^11 single dose --
REDWOOD CITY, Calif., May 01, 2021 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced new long-term data from the OPTIC clinical trial of ADVM-022 single intravitreal (IVT) injection gene therapy in patients requiring frequent anti-VEGF injections for their neovascular or wet age-related macular degeneration (wet AMD). Safety and efficacy data from patients followed for a median of 88 and 68 weeks at the 2 x 10^11 vg/eye dose (for Cohorts 2 & 3, respectively) and 104 and 36 weeks at the 6 x 10^11 vg/eye dose (for Cohorts 1 & 4, respectively) are being presented at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Virtual Meeting with a pre-recorded presentation uploaded on April 16, 2021.
“The long-term OPTIC data show the potential for ADVM-022 to offer disease modifying treatment for patients with wet AMD,” said Laurent Fischer, M.D., chief executive officer of Adverum Biotechnologies. “Patient safety is our absolute priority and following the unexpected adverse event we reported this past week in a patient treated with the 6e11 high dose in the INFINITY study in diabetic patients with macular edema, we are unmasking the INFINITY study in order to analyze all data available and monitor every patient who has received our gene therapy. We are also working closely with our data monitoring committee and scientific advisors and conducting a thorough review of all the data from our ADVM-022 program. We will report our findings as the analysis progresses to inform next steps for development.”
Dr. Fischer continued, “In OPTIC, ADVM-022 with wet AMD has demonstrated durability out to two years with the ease of a single, in-office intravitreal injection. We believe that we are well within the therapeutic window with the 2e11 dose with 60% of patients supplemental injection free beyond one year. Additionally, the aflibercept protein levels at the 2e11 dose were within the modeled therapeutic range and sustained out to at least one year, consistent with levels observed 4-6 weeks after an aflibercept injection.”
Adverum reported new interim data from the OPTIC trial (March 10, 2021 cutoff date, n=30) that continue to demonstrate the potential of ADVM-022 to greatly reduce the anti-VEGF injection burden for patients with wet AMD:
Cohort 3 Safety Data for 2 x 10^11 vg/eye Dose:
OPTIC Clinical Trial Data:
Brandon Busbee, M.D.?, partner, Tennessee Retina Physicians, and investigator in OPTIC, said, “I appreciate Adverum putting patient safety first as they seek to thoroughly review the data from the ADVM-022 program. I look forward to partnering with the company on ADVM-022’s future development for patients with wet AMD.”
ARVO 2021 Presentations
Poster Title: Preclinical Evaluation of ADVM-062, a Novel Intravitreal Gene Therapy for the Treatment of Blue Cone Monochromacy
These data presentations are available to ARVO participants and are posted on the Publications section of the Adverum’s website. Adverum is focused on conducting a thorough review of data from the ADVM-022 program in the context of the recent unexpected adverse event in the ADVM-022 INFINITY DME study and is therefore canceling its webcast to review these new OPTIC data, which was previously scheduled for Sunday, May 2, 2021.
About the OPTIC Phase 1 Trial of ADVM-022 in Wet AMD
For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03748784.
About ADVM-022 Gene Therapy
In recognition of the need for new treatment options for wet AMD, the U.S. Food and Drug Administration granted Fast Track designation for ADVM-022 for the treatment of wet AMD.
About Wet AMD
Wet AMD is a leading cause of vision loss in patients over 60 years of age, with a prevalence of approximately 1.2 million individuals in the U.S. and 3 million worldwide1. The incidence of new cases of wet AMD in the U.S. is approximately 150,000 to 200,000 annually, and this number is expected to grow significantly as the country’s population ages2,3.
The current standard-of-care therapies for wet AMD are anti-VEGF proteins. These therapies can be burdensome, as patients generally require chronic intravitreal (IVT) injection of anti-VEGF protein every 4-12 weeks. Compliance with this regimen can be difficult for patients and their caregivers, leading to compliance deficiencies and loss of vision from underdosing. It is estimated that these standard-of-care branded anti-VEGF therapies used for the treatment of wet AMD, DR, retinal vein occlusion, and other ocular diseases generated in excess of $11 billion in sales worldwide in 20204.
1 Arch Ophthalmol. 2004;122(4):564-572. doi:10.1001/archopht.122.4.564.
About Adverum Biotechnologies
Investor Relations Contacts Myesha Lacy Adverum Biotechnologies, Inc. T: 650-649-1257 E: email@example.com Amy Figueroa Adverum Biotechnologies, Inc. T: 650-823-2704 E: firstname.lastname@example.org Media Contact Andrea Cohen Sam Brown Inc. T: 917-209-7163 E: email@example.com
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