Drugs / Brolucizumab
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed diabetic macular edema 2 milestones | |||||
| Filed | Japan (PMDA) | Beovu | diabetic macular edema | 2021-10-13 | “Additionally, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) accepted an application for Beovu in the treatment of DME.” novartis.com ↗ |
| Filed | US (FDA) | Beovu | diabetic macular edema | — | “Regulatory applications for Beovu in DME are under review by the U.S. Food and Drug Administration (FDA).” novartis.com ↗ |
| Filed wet macular degeneration 2 milestones | |||||
| Filed | EU (EMA) | — | wet macular degeneration | 2019-04-24 | “Brolucizumab (RTH258) filed in the EU and US with PRV” novartis.com ↗ |
| Filed | US (FDA) | — | wet macular degeneration | 2019-04-15 | “FDA accepted the company's Biologics License Application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration” novartis.com ↗ “Brolucizumab (RTH258) filed in the EU and US with PRV” novartis.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | BEOVU | — | 2022-05-27 | fda.gov ↗ |
| Approved | EU (EMA) | Beovu | — | 2020-02-13 | europa.eu ↗ |
| Approved | US (FDA) | BEOVU | — | 2019-10-07 | fda.gov ↗ |
Trials 35
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01304693 | Oct 2010 → Mar 2013 | wet macular degeneration | Alcon Research | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT02507388 | Aug 2015 → Sep 2016 | wet macular degeneration | Alcon Research | Completed | No outcome recorded |
| Phase 2 | NCT01849692 | Jun 2013 → Jan 2015 | wet macular degeneration | Alcon Research | Completed | No outcome recorded |
| Phase 2 | NCT01796964 | Mar → Oct 2013 | age-related macular degeneration | Alcon Research | Completed | Met primary |
| Phase 321 trials · 5 met primary · 2 missed | ||||||
| Phase 3 | NCT05672979 | Jan 2023 → Dec 2024 | age-related macular degeneration, choroidal neovascularization | Yeungnam University College of Medicine | Unknown | No outcome recorded |
| Phase 3 | NCT04697953 | May → Jun 2021 | age-related macular degeneration | Novartis Pharmaceuticals | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04079231 | Feb 2021 → Jan 2023 | diabetic macular edema | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 3 | NCT04239027 | Jan 2021 → May 2022 | wet macular degeneration | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT04597632 | Dec 2020 → Mar 2023 | wet macular degeneration | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT04264819 | Dec 2020 → Oct 2022 | wet macular degeneration | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT04278417 | Nov 2020 → Oct 2023 | proliferative diabetic retinopathy | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT04047472 | Nov 2019 → Feb 2024 | wet macular degeneration | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT04005352 | Sep 2019 → Sep 2022 | age-related macular degeneration | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT04058067 | Aug 2019 → Jan 2023 | diabetic macular edema | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT03917472 | Jul 2019 → Mar 2021 | diabetic macular edema | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03810313 | Jul 2019 → Jul 2021 | central retinal vein occlusion | Novartis Pharmaceuticals | Terminated | Missed primary |
| Phase 3 | NCT03802630 | Jul 2019 → Jul 2021 | occlusion of tributary of retinal vein | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT03954626 | Jun → Jul 2019 | wet macular degeneration | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03930641 | May → Jul 2019 | wet macular degeneration | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03710564 | Oct 2018 → Dec 2020 | age-related macular degeneration | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03481660 | Jul 2018 → Jun 2020 | diabetic macular edema | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03481634 | Jul 2018 → Nov 2020 | diabetic macular edema | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03386474 | Jan → Sep 2018 | wet macular degeneration | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02434328 | Jul 2015 → Apr 2017 | choroidal neovascularization, wet macular degeneration | Alcon Research | Completed | Met primary |
| Phase 3 | NCT02307682 | Dec 2014 → Apr 2017 | choroidal neovascularization, wet macular degeneration | Alcon Research | Completed | Met primary |
| Phase 49 trials | ||||||
| Phase 4 | NCT05959304 | Dec 2024 → Nov 2025 | diabetic macular edema | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT06498050 | Jul 2024 → Jul 2025 overdue | diabetic macular edema | Guangdong Provincial People's Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05710471 | Jul 2022 → Jul 2023 | age-related macular degeneration | The University of Hong Kong | Completed | No outcome recorded |
| Phase 4 | NCT05269966 | Mar 2022 → Aug 2023 | wet macular degeneration | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT04774926 | Oct 2021 → Oct 2023 | wet macular degeneration | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT04679935 | Jul 2021 → Jan 2024 | age-related macular degeneration | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT04698850 | Jan 2021 → Jan 2023 | wet macular degeneration | Faculty Hospital Kralovske Vinohrady | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT04690062 | Oct 2020 → Dec 2022 | retinal dystrophy with or without macular staphyloma | Benha University | Unknown | No outcome recorded |
| Phase 4 | NCT04287348 | Jul 2020 → Nov 2021 | wet macular degeneration | Vista Klinik | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07096713 | Jan → Jun 2024 | — | Benha University | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 3 | NCT06985706 Comparator | May 2025 → Nov 2028 expected | diabetic macular edema | Belfast Health and Social Care Trust | Recruiting | No outcome recorded |
| Phase 3 | NCT05666804 Comparator | Feb 2023 → Sep 2025 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT04955171 Comparator | Jan 2021 → Mar 2022 | diabetic macular edema | Benha University | Unknown | No outcome recorded |
| — | NCT04932980 Comparator | May 2022 → Jun 2027 expected | wet macular degeneration | Berner Augenklinik | Active not recruiting | No outcome recorded |
| — | NCT04882956 Comparator | Aug 2020 → Dec 2021 | macular degeneration | Benha University | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2022-03-31 | Novartis Pharmaceuticals | Regulatory Novartis announces European Commission approval of Beovu® for people living with diabetic macular edema novartis.com ↗
Novartis today announced that the European Commission (EC) has approved Beovu ® (brolucizumab) 6 mg for the treatment of visual impairment due to diabetic macular edema (DME). |
| 2021-12-09 | Novartis Pharmaceuticals | Results Novartis announces positive results from year two of the Phase III trial of Beovu® in diabetic macular edema novartis.com ↗
Novartis today announced the first interpretable results from year two (week 100) of the Phase III KESTREL study. |
| 2021-10-13 | Novartis Pharmaceuticals | Regulatory Novartis announces FDA and EMA filing acceptances of Beovu® for patients with diabetic macular edema novartis.com ↗
Additionally, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) accepted an application for Beovu in the treatment of DME. |
| 2021-08-17 | Novartis Pharmaceuticals | Results Novartis announces positive results from Phase III trials of Beovu® in diabetic macular edema, including dosing intervals up to 16 weeks novartis.com ↗
Novartis today announced positive results from two Phase III clinical trials assessing Beovu ® (brolucizumab) 6 mg versus aflibercept 2 mg in patients with diabetic macular edema (DME). |
| 2021-05-28 | Novartis Pharmaceuticals | Results Novartis reports one year results of Phase III MERLIN study evaluating Beovu® every four week dosing and provides update on Beovu clinical program novartis.com ↗ |
| 2021-05-01 | Novartis Pharmaceuticals | Results Novartis Phase III Beovu® data show potential for fluid resolution in more diabetic macular edema patients with fewer injections versus aflibercept novartis.com ↗
Novartis today announced positive one-year results of the Phase III KESTREL and KITE* studies, evaluating the efficacy and safety of Beovu ® (brolucizumab) 6 mg in diabetic macular edema (DME). |
| 2020-12-15 | Novartis Pharmaceuticals | Results Novartis reports positive topline results from second Phase III trial of Beovu® in patients with diabetic macular edema novartis.com ↗
Novartis today announced positive findings from the first interpretable results of the Phase III KESTREL study, assessing the efficacy and safety of Beovu® (brolucizumab) 3 mg and 6 mg in diabetic macular edema (DME). |
| 2020-11-13 | Novartis Pharmaceuticals | Results Results from real-world data and post-hoc analysis of Novartis Beovu® pivotal trials presented at AAO 2020 novartis.com ↗ |
| 2020-10-05 | Novartis Pharmaceuticals | Results New Phase III analysis demonstrates Novartis Beovu® showed improvement in best-corrected visual acuity in wet AMD patients with early persistent fluid novartis.com ↗ |
| 2020-09-14 | Novartis Pharmaceuticals | Results Novartis reports positive topline results from the first Phase III trial of Beovu® versus aflibercept in patients with diabetic macular edema (DME) novartis.com ↗
The trial met its primary and key secondary endpoints, demonstrating non-inferiority for Beovu versus aflibercept 2 mg in mean change in best-corrected visual acuity (BCVA) at year one (week 52) 1 . |
| 2020-09-14 | Novartis Pharmaceuticals | Regulatory European Medicines Agency (EMA) approves safety label update for Novartis Beovu® novartis.com ↗
Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP), has approved an update to the Beovu® (brolucizumab) Summary of Product Characteristics (SmPC) to include additional information regarding retinal vasculitis and retinal vascular occlusion 1 . |
| 2020-07-27 | Novartis Pharmaceuticals | Results New Novartis analysis shows wet AMD patients achieved sustained fluid control faster with Beovu® versus aflibercept novartis.com ↗
In both trials, >=50% of patients achieved sustained dryness faster with Beovu (by weeks 8 and 4 in HAWK and HARRIER, respectively, and by weeks 12 and 8 with aflibercept) 1 . |
| 2020-06-11 | Novartis Pharmaceuticals | Regulatory US FDA approves updated Novartis Beovu® label, to include additional safety information novartis.com ↗
Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Beovu ® (brolucizumab) to include additional safety information regarding retinal vasculitis and retinal vascular occlusion |
| 2020-02-17 | Novartis Pharmaceuticals | Regulatory Novartis receives EC Approval for Beovu®, a next-generation anti-VEGF treatment for wet AMD, a leading cause of blindness worldwide novartis.com ↗
Basel, February 17, 2020 – Novartis today announced the European Commission (EC) has approved Beovu ® (brolucizumab) injection for the treatment of wet age-related macular degeneration (AMD). |
| 2019-12-13 | Novartis Pharmaceuticals | Regulatory Novartis receives positive CHMP opinion for Beovu® (brolucizumab) for the treatment of wet AMD novartis.com ↗ |
| 2019-10-08 | Novartis Pharmaceuticals | Regulatory Novartis receives FDA approval for Beovu®, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept novartis.com ↗
Novartis today announced that the U.S. Food and Drug Administration (FDA) approved Beovu® (brolucizumab) injection, also known as RTH258 for the treatment of wet age-related macular degeneration (AMD)[1]. |
| 2019-04-15 | Novartis Pharmaceuticals | Regulatory Novartis announces FDA filing acceptance and Priority Review of brolucizumab (RTH258) for patients with wet AMD novartis.com ↗
Novartis announced that the US Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD), also known as neovascular AMD, or nAMD. |
| 2018-10-27 | Novartis Pharmaceuticals | Results Two-year data for Novartis brolucizumab reaffirm superiority versus aflibercept in reducing retinal fluid in patients with nAMD novartis.com ↗
Secondary endpoints at year two (96 weeks) reaffirmed superiority of brolucizumab 6 mg in reduction of retinal fluid, an important marker of disease activity in patients with neovascular age-related macular degeneration (nAMD)[1],[3]. |
| 2018-09-22 | Novartis Pharmaceuticals | Results New analysis of Novartis Phase III brolucizumab (RTH258) data reinforces superior reduction of retinal fluid, a key marker of disease activity in nAMD novartis.com ↗
The data show that brolucizumab 6 mg had superior fluid resolution versus aflibercept over four visits during weeks 36 to 48. |
| 2018-04-30 | Novartis Pharmaceuticals | Results New Novartis Phase III data for brolucizumab demonstrate reliability of 12-week treatment interval novartis.com ↗
Novartis announced new positive brolucizumab (RTH258) data in neovascular age-related macular degeneration (nAMD) from a pre-specified secondary analysis of the Phase III HAWK and HARRIER trials. |
| 2017-11-10 | Novartis Pharmaceuticals | Results Novartis brolucizumab (RTH258) demonstrates superiority versus aflibercept in key secondary endpoint measures of disease activity in nAMD, a leading cause of blindness novartis.com ↗
Novartis, a global leader in ophthalmology, announced further positive results from two Phase III studies of brolucizumab versus aflibercept. |
| 2017-06-20 | Novartis Pharmaceuticals | Results Novartis RTH258 (brolucizumab) demonstrates robust visual gains in nAMD patients with a majority on a 12-week injection interval novartis.com ↗
Novartis, the global leader in Ophthalmology, today reported that RTH258 (brolucizumab) 6 mg met the primary and key secondary endpoints in two Phase III studies, HAWK and HARRIER. |
| 2015-02-27 | Novartis Pharmaceuticals | Results Positive phase II data highlights benefits of Alcon's RTH258 for patients with neovascular (wet) age-related macular degeneration novartis.com ↗
The Phase II study met its primary endpoint, demonstrating promising visual acuity gains that were non-inferior to aflibercept, with numerically greater reduction and rapid improvement in abnormal retinal fluid observed in RTH258-treated patients. |
All press releases naming this drug 28 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 43 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Brolucizumab | “Anti-VEGFs including ranibizumab and biosimilars, aflibercept, faricimab, and brolucizumab will be used, as per the standard of care at participating sites.” NCT06985706 ↗33“This is a single-arm, open-label, multicenter study that collected ECG data after a single IVT injection of brolucizumab 6 mg in patients with nAMD.” NCT03954626 ↗ “Intravitreal injection of Brolucizumab(BEOVU®, Genentech, South Francisco, CA) and of aflibercept (Eylea;Regeneron, Tarrytown,NY)” NCT04955171 ↗ |
| Known as | Beovu | “Intravitreal injection of Brolucizumab(BEOVU®, Genentech, South Francisco, CA) and of aflibercept (Eylea;Regeneron, Tarrytown,NY)” NCT04955171 ↗3“administration of anti-VEGF Brolucizumab (Beovu)” NCT04932980 ↗ “brolucizumab treatment (Beovu, Novartis)” PMID 37343623 ↗ Jun 2023 “Brolucizumab Injection [Beovu]” NCT05672979 ↗ |
| Known as | Brolucizumab-dbll | “Outcome of Brolucizumab-dbll and Aflibercept Intravitreal Injection in the Treatment of Age-related Macular Neovascular Degeneration” NCT04882956 ↗ |
| Known as | ESBA1008 | “Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.” NCT05269966 ↗ |
| Known as | RTH258 | “Brolucizumab (also known as "RTH258" and "ESBA1008") is a humanized, single-chain variable fragment (scFv) antibody with a molecular mass of approximately 26 kDa that inhibits VEGF-A.” PMID 32107066 ↗ Jan 2020 |
| Action | Inhibit | “a single-chain antibody fragment that inhibits vascular endothelial growth factor-A” PMID 30986442 ↗ Apr 2019 |
| Modality | Other / unclassified | “a single-chain antibody fragment” PMID 30986442 ↗ Apr 2019 |
| Route | Intravitreal | “Administered as a single intravitreal injection (Dose A, Dose B, Dose C, Dose D)” NCT01304693 ↗ |
| Target | VEGFA | “a single-chain antibody fragment that inhibits vascular endothelial growth factor-A” PMID 30986442 ↗ Apr 2019 |