This section highlights FDA-related milestones and regulatory updates for drugs developed by Adverum Biotechnologies (ADVM).
Over the past two years, Adverum Biotechnologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ixoberogene and Ixo-vec. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ixoberogene soroparvovec (Ixo-vec) - FDA Regulatory Timeline and Events
ixoberogene soroparvovec (Ixo-vec) is a drug developed by Adverum Biotechnologies for the following indication: For the treatment of wet age-related macular degeneration (wet AMD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ixoberogene soroparvovec (Ixo-vec)
- Announced Date:
- July 17, 2024
- Indication:
- For the treatment of wet age-related macular degeneration (wet AMD)
Announcement
Adverum Biotechnologies, Inc y announced results from the landmark 26-week interim analysis of the ongoing LUNA Phase 2 trial of Ixo-vec in patients with wet age-related macular degeneration (AMD).
AI Summary
Adverum Biotechnologies, Inc. announced positive findings from the landmark 26‐week interim analysis of its ongoing LUNA Phase 2 trial of Ixo‑vec in patients with wet age-related macular degeneration (AMD). The study used the 6E10 dose combined with local prophylaxis, showing a promising product profile. Notably, 76% of patients receiving the 6E10 dose were free from additional injections while maintaining stable visual acuity and controlling retinal fluid. In terms of safety, 100% of patients on the difluprednate-alone regimen experienced no or minimal inflammation, and no extra corticosteroids were needed beyond the scheduled prophylaxis. Additionally, a patient survey revealed strong favorability, with 88% preferring Ixo‑vec over previous treatments and 93% willing to use it in the other eye. These positive interim results have informed the selection of 6E10 for upcoming Phase 3 studies.
Read Announcement- Drug:
- ixoberogene soroparvovec (Ixo-vec)
- Announced Date:
- July 17, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 - 2024
- Indication:
- For the treatment of wet age-related macular degeneration (wet AMD)
Announcement
Adverum Biotechnologies, Inc announced that LUNA 9-month landmark analysis and pivotal trial design update anticipated in 4Q 2024
AI Summary
Adverum Biotechnologies, Inc. recently announced an important update regarding its LUNA Phase 2 study. The company revealed that they anticipate presenting the 9-month landmark analysis and a pivotal Phase 3 trial design update in the fourth quarter of 2024. This update follows promising interim results from the 26-week analysis in patients with wet age-related macular degeneration (AMD), where the product showed a potential best-in-class profile with a favorable safety outcome and reduced treatment burden.
The clinical data suggest that patients receiving the lower 6E10 dose could manage inflammation effectively with local prophylactic treatment, while many remained free of injections at 26 weeks. This development highlights Adverum's commitment to shifting the treatment paradigm for wet AMD, aiming to offer a more durable therapy option that could reduce the need for frequent anti-VEGF injections.
Read Announcement- Drug:
- ixoberogene soroparvovec (Ixo-vec)
- Announced Date:
- July 10, 2024
- Indication:
- For the treatment of wet age-related macular degeneration (wet AMD)
Announcement
Adverum Biotechnologies, Inc announced that the company will host a webcast to review the interim 26-week landmark data from its ongoing LUNA Phase 2 study of ixoberogene soroparvovec (Ixo-vec) for the treatment of wet age-related macular degeneration (wet AMD) being presented at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting.
AI Summary
Adverum Biotechnologies recently announced that it will host a webcast to review important clinical data from its ongoing LUNA Phase 2 study. The study is evaluating ixoberogene soroparvovec (Ixo-vec), a gene therapy candidate for treating wet age-related macular degeneration (wet AMD). The webcast, scheduled for Wednesday, July 17, 2024, at 8:00 a.m. ET, will feature insights into the landmark 26-week interim data from the study. Dr. Charles C. Wykoff, a principal investigator in the study and a noted expert from the Houston Methodist Hospital, is set to present the findings. The results, which highlight the potential of Ixo-vec as a one-time gene therapy to reduce the need for frequent treatments, will also be discussed at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting.
Read Announcement
Ixo-vec - FDA Regulatory Timeline and Events
Ixo-vec is a drug developed by Adverum Biotechnologies for the following indication: For the Treatment of Wet AMD.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Ixo-vec
- Announced Date:
- March 3, 2025
- Indication:
- For the Treatment of Wet AMD
Announcement
Adverum Biotechnologies, Inc. announced the initiation of the ARTEMIS Phase 3 study.
AI Summary
Adverum Biotechnologies, Inc. has started the ARTEMIS Phase 3 study, a pivotal trial that could lead to a new gene therapy for wet age-related macular degeneration (AMD). This study is the first to test a one-time intravitreal (IVT) injection of Ixo-vec, aiming to provide a long-term treatment option compared to the current standard of care. The trial will compare a single Ixo-vec injection to the approved treatment with aflibercept, given every eight weeks, in about 284 patients, including those who are treatment-naïve and those who have been previously treated.
The study is designed to assess if Ixo-vec is no worse than aflibercept in improving vision over one year. Before receiving Ixo-vec or continuing with aflibercept, all patients will get three loading doses of aflibercept. This trial represents a significant step toward reducing treatment burden and could transform vision care for wet AMD patients.
Read Announcement- Drug:
- Ixo-vec
- Announced Date:
- August 1, 2024
- Indication:
- For the Treatment of Wet AMD
Announcement
Adverum Biotechnologies, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Ixo-vec, its clinical-stage gene therapy product candidate, for the treatment of wet AMD.
AI Summary
Adverum Biotechnologies announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for its clinical-stage gene therapy candidate, Ixo-vec, targeted for the treatment of wet age-related macular degeneration (AMD). This designation recognizes the promising clinical data and the potential of Ixo-vec to transform how wet AMD is treated. It is designed as a one-time intravitreal injection that could offer long-lasting benefits and reduce the frequent injections required by current therapies. The RMAT status provides Adverum with intensive FDA guidance, potential priority review, and opportunities to expedite the development and review processes. This advancement reinforces the company’s commitment to developing innovative, one-time treatments that meet significant unmet needs for patients suffering from this sight-threatening condition.
Read Announcement
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