Drugs / ADVM-022
ADVM-022
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | wet macular degeneration | 2020-11-05 | “Adverum has received notification that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on ADVM-022” adverum.com ↗ “placing Adverum’s IND application for ADVM-022 for the treatment of wet AMD on clinical hold.” adverum.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03748784 | Nov 2018 → Jun 2022 | wet macular degeneration | Adverum Biotechnologies, Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05536973 | Aug 2022 → Aug 2024 overdue | wet macular degeneration | Adverum Biotechnologies, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04418427 | May 2020 → Nov 2022 | diabetic macular edema | Adverum Biotechnologies, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 48
| Date | Issuer | Release |
|---|---|---|
| 2024-11-18 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces Positive 52-Week LUNA and 4-Year OPTIC Results, and Provides Key Pivotal Program Design Elements adverum.com ↗
Both OPTIC 2E11 results and LUNA efficacy data at 52 weeks show maintenance of visual and anatomic endpoints with over 80% reduction in injection burden and greater than 50% injection freedom. |
| 2024-08-01 | Adverum Biotechnologies, Inc. | Regulatory Adverum Biotechnologies Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted for Ixo-vec for the Treatment of Wet AMD adverum.com ↗ |
| 2024-07-17 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Presents Positive Ixo-vec Clinical Data from the 26-Week Interim Analysis of the LUNA Phase 2 Trial at the 2024 ASRS Annual Meeting adverum.com ↗
100% of 6E10 difluprednate-alone patients had no or minimal inflammation, and none received corticosteroids for treatment of inflammation beyond the scheduled prophylaxis |
| 2024-02-08 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces Positive Preliminary Efficacy and Safety Data from LUNA Phase 2 Trial of Ixo-vec in Patients with Wet AMD adverum.com ↗
Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company pioneering the use of gene therapy as a new standard of care for highly prevalent ocular diseases, today announced preliminary safety and efficacy data from the ongoing LUNA Phase 2 trial in patients with wet age-related macular degeneration (AMD). |
| 2023-11-04 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces 3-Year Efficacy and Safety Results from the OPTIC Extension Study in Patients with Wet AMD at AAO 2023 adverum.com ↗
Patients in the OPTIC extension trial continue to experience long-term benefit from Ixo-vec through 3 years of follow-up, including maintenance of vision, durability of anatomical improvements and sustained reduction in anti-VEGF treatment burden. |
| 2023-09-26 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces Positive Aflibercept Protein Level Data from the LUNA Phase 2 Trial adverum.com ↗
New data announced today include aflibercept protein levels for both the 2E11 and 6E10 vg/eye doses, suggesting that both doses are within the therapeutically active range. |
| 2023-05-18 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Presents Nonclinical Data in Support of Ixo-vec’s Phase 2 Clinical Development at ASGCT 2023 Annual Meeting adverum.com ↗
Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced new nonclinical data supporting the use of ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022) at the American Society of Gene & Cell Therapy (ASGCT) 2023 Annual Meeting in Los Angeles, California. |
| 2023-05-02 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces Upcoming Data Presentations at ASGCT 2023 including Data on a New Intravitreal (IVT) Program for Geographic Atrophy Secondary to Dry AMD adverum.com ↗
The first of two oral presentations will feature nonclinical data in NHP that support staggered bilateral administration of Ixo-vec in the treatment of wet AMD. |
| 2023-04-23 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Presents Nonclinical Data at the 2023 ARVO Annual Meeting Supporting Potential for Staggered Bilateral Administration of Ixo-vec adverum.com ↗
Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced nonclinical data supporting the two doses of ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022) being evaluated in the Phase 2 LUNA trial and the potential for staggered, bilateral administration in the treatment of wet AMD. |
| 2023-04-18 | Adverum Biotechnologies, Inc. | Regulatory Adverum Biotechnologies Granted Innovative Licensing and Access Pathway Designation in the United Kingdom for Ixo-vec for the Treatment of Wet AMD adverum.com ↗
today announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Ixo-vec ( ixoberogene soroparvovec) , an investigational gene therapy for the treatment of wet AMD, an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP). |
| 2022-11-04 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Presents Positive End of Study Results from the OPTIC Trial in Wet AMD Including Two-Year Outcomes Following a Single Intravitreal Injection of Ixo-vec (ADVM-022) adverum.com ↗
Mean best-corrected visual acuity (BCVA) and central subfield thickness (CST) were maintained or improved across both 6E11 and 2E11 doses |
| 2022-09-30 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Presents Anatomical Improvements in Intraretinal and Subretinal Fluid After a Single IVT Injection of Ixo-vec (ADVM-022) in the OPTIC Study in Wet AMD adverum.com ↗
The 2×10^11 vg/eye (2E11) dose meaningfully reduced fluid volume, including a 93% reduction in intraretinal (IRF) and 55% reduction in subretinal fluid (SRF) from baseline to week 48 |
| 2022-07-15 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Presents Best-Corrected Visual Acuity and Central Subfield Thickness Analyses After a Single IVT Injection of ADVM-022 (Ixo-vec) in the OPTIC Study in Wet AMD adverum.com ↗
Mean best-corrected visual acuity and central subfield thickness were maintained or improved in subjects treated with ADVM-022 |
| 2022-06-24 | Adverum Biotechnologies, Inc. | Regulatory Adverum Biotechnologies Granted Priority Medicines (PRIME) Designation by European Medicines Agency for ADVM-022 in Wet AMD adverum.com ↗
Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that the European Medicines Agency (EMA) has granted ADVM-022 Priority Medicines (PRIME) designation for the treatment of wet age-related macular degeneration (wet AMD). |
| 2022-06-09 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Presents Three-Year Aflibercept Protein Expression and Improvement in Anatomic Outcomes After a Single IVT Injection of ADVM-022 in the OPTIC Study in Wet AMD adverum.com ↗
New analyses presented include three-year aflibercept protein expression and improved anatomical outcomes in subjects treated with ADVM-022. |
| 2022-06-02 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces New Data at the Macula Society’s 2022 Annual Meeting adverum.com ↗
OPTIC study of intravitreal gene therapy with ADVM-022 (AAV.7m8-aflibercept) for wet AMD shows therapeutic levels of aflibercept out to three years |
| 2022-05-17 | Adverum Biotechnologies, Inc. | Results Adverum Presents Data at ASGCT Further Supporting Phase 2 Development Plans for ADVM-022 adverum.com ↗
The data being presented during the American Society of Gene and Cell Therapy (ASGCT) 2022 Annual Meeting in Washington, D.C. and virtually, shows results of the non-human primate (NHP) studies that provide support for the new 6 X 10^10 vg/eye (6E10) dose that Adverum intends to include in its next clinical trial. |
| 2022-05-01 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Presents Additional Efficacy and Safety Data from the OPTIC Trial of ADVM-022 in Wet AMD at the ARVO 2022 Annual Meeting adverum.com ↗
In subjects with baseline NAbs <1:125, the reductions in mean annualized injection frequency increased to 94%. |
| 2022-04-19 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces Upcoming Data Presentations at ARVO 2022 adverum.com ↗
The reductions in mean annualized injection frequency in patients with baseline NAbs <1:125 were greater than 94%. |
| 2021-10-09 | Adverum Biotechnologies, Inc. | Results Adverum Presents Clinical Data on ADVM-022 at the American Society of Retina Specialists 39th Annual Scientific Meeting adverum.com ↗
To date, two other patients required surgery and a total of five of the twelve patients treated with the high dose have experienced clinically relevant IOP events requiring additional immunosuppressive agents |
| 2021-10-01 | Adverum Biotechnologies, Inc. | Results Adverum Presents 2-Year OPTIC Data Demonstrating Sustained Durability and Promising Safety Profile from Single Intravitreal Injection of ADVM-022 in Wet AMD Patients Who Previously Required Frequent Anti-VEGF Injections adverum.com ↗
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, in-office intravitreal (IVT) injection gene therapy in patients requiring frequent anti-VEGF injections for their neovascular or wet age-related macular degeneration (wet AMD). |
| 2021-07-22 | Adverum Biotechnologies, Inc. | Results Adverum Provides Update on ADVM-022 and the INFINITY Trial in Patients with Diabetic Macular Edema adverum.com ↗
Adverum no longer plans future development for DME after a dose-limiting toxicity (DLT) not seen before in ocular gene therapy or anti-VEGF treatment has been observed at the high dose (6 x 10^11 vg/eye) in patients with DME. |
| 2021-05-01 | Adverum Biotechnologies, Inc. | Results 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 adverum.com ↗
The long-term OPTIC data show the potential for ADVM-022 to offer disease modifying treatment for patients with wet AMD, |
| 2021-04-28 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Provides Update on the INFINITY Trial Evaluating ADVM-022 in Patients with Diabetic Macular Edema adverum.com ↗
Adverum Biotechnologies, Inc. (Nasdaq: ADVM) announced a Suspected Unexpected Serious Adverse Reaction (SUSAR) of hypotony (clinically-relevant decrease in ocular pressure) in its INFINITY clinical trial evaluating ADVM-022 gene therapy for the treatment of diabetic macular edema (DME). |
| 2021-02-02 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces Publication of Preclinical Long-Term Safety Data on ADVM-022 IVT Gene Therapy adverum.com ↗
In this preclinical study, we saw long-term, sustained aflibercept expression out to 30 months following ADVM-022. |
| 2020-11-14 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces Positive Interim Data from Cohorts 1-4 from OPTIC Phase 1 Trial of ADVM-022 Intravitreal Gene Therapy for Wet AMD adverum.com ↗ |
| 2020-08-10 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces Positive Interim Data from Cohorts 1-4 from OPTIC Phase 1 Trial of ADVM-022 Intravitreal Gene Therapy for wet AMD, Reports Recent Business Progress and Second Quarter 2020 Financial Results adverum.com ↗
today announced positive new interim data from Cohorts 1-4 of the OPTIC Phase 1 clinical trial of ADVM-022 intravitreal (IVT) injection gene therapy in patients requiring frequent anti-VEGF injections for their wet age-related macular degeneration (AMD). |
| 2020-05-04 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Reports Positive Interim Data from Cohorts 1-3 of OPTIC Phase 1 Trial of ADVM-022 Intravitreal Gene Therapy for Wet AMD adverum.com ↗ |
| 2020-02-08 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Reports New Interim Data from Cohorts 1 and 2 of OPTIC Phase 1 Trial of ADVM-022 Intravitreal Gene Therapy for Wet AMD at Angiogenesis, Exudation, and Degeneration 2020 adverum.com ↗
Cohort 1: 6 of 6 patients remain rescue-injection-free at a median follow up of 50 weeks, with 3 patients at 52 weeks. |
| 2020-01-11 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Reports Additional Clinical Data from First Cohort of OPTIC Phase 1 Trial of ADVM-022 Intravitreal Gene Therapy for Wet AMD at the Atlantic Coast Retina Club Macula 20/20 Annual Meeting adverum.com ↗
Today, additional data for the first cohort are being presented, including efficacy and safety data, with a median follow up of 44 weeks at a range of 40-52 weeks, and included: Zero rescue injections for any patient. |
| 2019-10-11 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Reports Additional Clinical Data from First Cohort of OPTIC Phase 1 Trial of ADVM-022 Intravitreal Gene Therapy for Wet AMD at the American Academy of Ophthalmology 2019 Annual Meeting adverum.com ↗ |
| 2019-09-12 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Reports Positive 24-Week Data from First Cohort of OPTIC Phase 1 Trial of ADVM-022 Intravitreal Gene Therapy to Treat Wet AMD adverum.com ↗
Patients treated in this cohort achieved vision maintenance and improvements in retinal anatomy, with zero anti-VEGF rescue injections required, after a one-time intravitreal dose of ADVM-022, through week 24. |
| 2019-05-16 | Adverum Biotechnologies, Inc. | Regulatory Adverum Biotechnologies Provides Update on OPTIC Phase 1 Trial for ADVM-022 in Wet AMD adverum.com ↗ |
| 2019-05-02 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies to Present 30-month Preclinical Safety and Expression Data for ADVM-022 Gene Therapy in Wet AMD at the ASGCT 22nd Annual Meeting adverum.com ↗
The preclinical data on ADVM-022 demonstrate long-term safety and aflibercept expression following a single intravitreal injection of this novel gene therapy. |
| 2019-04-30 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Presents First Preclinical Data on Dosing Contralateral Eye with ADVM-022 Gene Therapy for Wet AMD at the ARVO 2019 Annual Meeting adverum.com ↗
The data presented today in a poster session at the Association for Research in Vision and Ophthalmology (ARVO) 2019 Annual Meeting in Vancouver, BC demonstrate that ADVM-022 can be administered safely to the second eye, 2 months after injection in the first eye. |
| 2019-04-16 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies to Present New Preclinical Data on ADVM-022 Gene Therapy for Wet AMD at ASGCT and ARVO adverum.com ↗
We are pleased to be sharing these new preclinical non-human primate data that add to the growing body of evidence demonstrating ADVM-022 gene therapy’s long-term durability and safety, |
| 2019-04-15 | Adverum Biotechnologies, Inc. | Regulatory Adverum Biotechnologies Provides Clinical Program Update on ADVM-022 Gene Therapy for Wet AMD adverum.com ↗
The FDA has placed the Company’s IND on clinical hold until the agency has reviewed Adverum’s response, which was submitted last week. |
| 2019-02-11 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces Presentation of Preclinical Long-Term Safety Data of ADVM-022 at 2019 Angiogenesis, Exudation, and Degeneration Conference adverum.com ↗
We are excited to share interim data from a preclinical study which show that the normal non-human primate retinal structure is maintained 21 months after a single intravitreal injection of 2×10^12 vg of ADVM-022, as measured by optical coherent tomography. |
| 2018-12-03 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces Publication of Preclinical Long-Term Expression and Efficacy Data in Molecular Therapy adverum.com ↗
A single intravitreal administration of ADVM-022 in non-human primates (NHPs) provided stable and robust intraocular expression of aflibercept and resulted in high levels of aflibercept within the retina and choroid where wet age-related macular degeneration (wet AMD) occurs |
| 2018-10-17 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces Data Presented at the European Society of Gene and Cell Therapy (ESGCT) adverum.com ↗
A single intravitreal injection of ADVM-022 in non-human primates (NHP) demonstrated durable expression of aflibercept sustained out to 22 months |
| 2018-09-19 | Adverum Biotechnologies, Inc. | Regulatory Adverum Biotechnologies Receives Fast Track Designation for ADVM-022 Gene Therapy for the Treatment of wAMD adverum.com ↗
today announced the U.S. Food and Drug Administration ( FDA ) has granted Fast Track designation for ADVM-022. |
| 2018-08-29 | Adverum Biotechnologies, Inc. | Regulatory Adverum Biotechnologies Announces IND Active for ADVM-022, a Novel Gene Therapy to Treat Wet Age-related Macular Degeneration adverum.com ↗
Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in serious rare and ocular diseases, today announced its Investigational New Drug (IND) application is active for the planned multi-center, open-label, Phase 1, dose-escalation study of ADVM-022, a novel gene therapy candidate for the treatment of wet age-related macular degeneration (wAMD). |
| 2018-08-01 | Adverum Biotechnologies, Inc. | Regulatory Adverum Biotechnologies Announces Clinical Progress Across Gene Therapy Pipeline adverum.com ↗
In addition, we have completed the IND submission of ADVM-022 for wet AMD |
| 2018-05-17 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Presents Additional Long-term Preclinical Data on ADVM-022 in Wet AMD at ASGCT 21st Annual Meeting adverum.com ↗
After 13 months, a single intravitreal injection of ADVM-022 was found to be safe and statistically significant (p<0.0001) in preventing the development of Grade IV lesions compared to the vehicle control group. |
| 2018-05-01 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces Long-term Preclinical Efficacy Data on ADVM-022 Gene Therapy in Wet AMD adverum.com ↗
In this preclinical study, the efficacy of ADVM-022 at 13 months post-administration was consistent with earlier reported data, demonstrating that a single intravitreal injection of ADVM-022 was found to be safe and statistically significant (p<0.0001) in preventing the development of Grade IV lesions compared to the vehicle control group. |
| 2017-09-27 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Presents Updated Preclinical Data on ADVM-022 in Wet AMD at the 2017 Targeting Ocular Disorders Conference adverum.com ↗
Today, additional pharmacokinetic data are being presented, demonstrating sustained expression for 52 weeks, with only mild ocular inflammation following a single intravitreal administration |
| 2016-10-20 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces Data Presentations at the European Society of Gene and Cell Therapy (ESGCT) Meeting adverum.com ↗ |
| 2016-09-16 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Presents Preclinical Data on Novel Gene Therapy Candidates for the Treatment of Wet AMD at The Retina Society 2016 Annual Meeting adverum.com ↗
To date additional pharmacokinetic studies of the vitreous and retinal tissue have shown durable anti-VEGF protein expression with therapeutic protein levels at least 20 weeks after a single intravitreal administration. |
All press releases naming this drug 78 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ADVM-022 | “We hypothesised that an in-office, intravitreal administration of ixoberogene soroparvovec (ixo-vec, formerly ADVM-022), a single-dose gene therapy encoding for the proven...” PMID 38152412 ↗ Dec 2023 |
| Known as | AAV.7m8-aflibercept | “ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product being developed for the treatment of nAMD” NCT05536973 ↗ |
| Known as | ixo-vec | “We hypothesised that an in-office, intravitreal administration of ixoberogene soroparvovec (ixo-vec, formerly ADVM-022), a single-dose gene therapy encoding for the proven...” PMID 38152412 ↗ Dec 20231“ADVM-022 (also known as Ixo-vec and AAV.7m8-aflibercept) is an investigational gene therapy product developed for the treatment of serious retinal vascular diseases including...” NCT04418427 ↗ |
| Known as | ixoberogene soroparvovec | “We hypothesised that an in-office, intravitreal administration of ixoberogene soroparvovec (ixo-vec, formerly ADVM-022), a single-dose gene therapy encoding for the proven...” PMID 38152412 ↗ Dec 2023 |
| Modality | Gene therapy (AAV / viral vector) | “gene therapy product” NCT04418427 ↗ |
| Route | Intravitreal | “an in-office, intravitreal administration of ixoberogene soroparvovec” PMID 38152412 ↗ Dec 2023 |