Brolucizumab

Overview

Brolucizumab, also known as RTH258 or ESBA1008, is a monoclonal antibody indicated to treat neovascular age related macular degeneration. Brolucizumab was granted FDA approval in October 2019.

Indication

Brolucizumab is a monoclonal antibody indicated to treat neovascular age related macular degeneration.

Associated Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Brolucizumab Efficacy and Safety Single-Arm Descriptive Trial in Patients With Persistent Diabetic Macular Edema	2024/07/12	NCT06498050	Phase 4	Active, not recruiting	Guangdong Provincial People's Hospital
Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With Immediate T&E	2023/02/02	NCT05710471	Phase 4	Completed	The University of Hong Kong
Prospective triAl of Modified Treat-and-extend Regimens With BroLucizumab in pachychOroid Neovasculopathy	2023/01/05	NCT05672979	Phase 3	Not yet recruiting	Yeungnam University College of Medicine
Study Assessing the Efficacy and Safety of a Personalized Monotherapy Regimen of Brolucizumab in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy	2022/12/28	NCT05666804	Phase 3	Active, not recruiting	Novartis Pharmaceuticals
Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)	2022/03/08	NCT05269966	Phase 4	Completed	Novartis Pharmaceuticals
Beovu Experience UZ Leuven	2022/02/02	NCT05220085	N/A	UNKNOWN	Universitaire Ziekenhuizen KU Leuven
Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)	2021/11/08	NCT05111743	N/A	Completed	Novartis Pharmaceuticals
Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (IRIS Study)	2021/10/19	NCT05082415	N/A	Completed	Novartis Pharmaceuticals
Evaluation of Number of Patient Eyes That Remained on or Switched to Anti-VEGF Treatment After Initiation of Broluciumab	2021/09/08	NCT05037396	N/A	Completed	Novartis Pharmaceuticals
BEOVU Versus Eylea in the Treatment of Diabetic Macular Edema	2021/07/08	NCT04955171	Phase 3	UNKNOWN	Benha University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Beovu	Novartis Europharm Limited,Vista Building,Elm Park,Merrion Road,Dublin 4,D04 A9N6,Ireland	Authorised	2/13/2020

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
BEOVU SOLUTION FOR INJECTION 6MG/0.05ML	N/A	NOVARTIS PHARMACEUTICALS (HK) LIMITED	N/A	N/A	3/1/2021

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
BEOVU brolucizumab (rbe) 120 mg/mL solution for injection in vial	313680	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	1/16/2020
BEOVU brolucizumab (rbe) 120 mg/mL solution for injection in pre-filled syringe	313681	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	1/16/2020
VSIQQ brolucizumab (rbe) 120 mg/mL solution for injection in vial	349910	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	1/28/2021

Related News

Brolucizumab Shows Promising One-Year Results in Wet AMD Treatment, Regardless of Prior Therapy

5 months ago

Real-world study demonstrates brolucizumab's effectiveness in treating wet AMD, with patients showing significant improvement in visual acuity over 12 months of treatment.

Faricimab Fails to Demonstrate Added Benefit for Macular Edema in German Assessment

6 months ago

German Institute for Quality and Efficiency in Health Care (IQWiG) found no proof of added benefit for faricimab over ranibizumab or aflibercept in treating macular edema.

Brolucizumab Shows Non-Inferior Visual Acuity and Superior Anatomic Outcomes Compared to Aflibercept in DME

7 months ago

• A recent meta-analysis of randomized controlled trials compared brolucizumab to aflibercept for treating diabetic macular edema (DME). • Brolucizumab was found to be non-inferior to aflibercept in terms of best-corrected visual acuity from baseline. • The study showed brolucizumab significantly improved anatomic parameters, specifically the change in central subfield thickness, compared to aflibercept. • No statistically significant differences in ocular adverse events were observed between the two anti-VEGF therapies.

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