Drugs / Lucentis

Regulatory milestones approvals, filings & regulatory actions · 11 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (9) US (FDA) LUCENTIS — 2008-04-23 – 2017-04-15 fda.gov ↗
Approved EU (EMA) Lucentis — 2007-01-22 europa.eu ↗
Approved US (FDA) LUCENTIS — 2006-06-30 fda.gov ↗

Trials 11

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial · 1 met primary
Phase 1 NCT02543229 Jul 2015 → Feb 2017 age-related macular degeneration, ocular vascular disorder Opthea Limited Completed Met primary
Phase 1/21 trial
Phase 1/2 NCT00467935 Mar → Nov 2007 macular degeneration Retina Research Foundation Completed No outcome recorded
Phase 24 trials · 1 missed
Phase 2 NCT03927690 May 2019 → Jun 2022 diabetic macular edema Novartis Pharmaceuticals Completed Missed primary
Phase 2 NCT05571267 Oct 2016 → Apr 2018 wet macular degeneration IVERIC bio, Inc. Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT01414153 Aug 2012 → May 2015 wet macular degeneration Lpath, Inc. Completed No outcome recorded
Phase 2 NCT00457678 Jan → Dec 2007 age-related macular degeneration Vitreous -Retina- Macula Consultants of New York Withdrawn No outcome recorded Stop: Enrollment
Phase 32 trials
Phase 3 NCT04667039 Mar 2022 → Aug 2024 wet macular degeneration AO GENERIUM Unknown No outcome recorded
Phase 3 NCT04063358 Aug 2019 → Aug 2021 cataract, diabetic macular edema Second Military Medical University Unknown No outcome recorded
Phase 42 trials
Phase 4 NCT03097068 Apr → Dec 2017 diabetic macular edema Vitreo-Retinal Associates, Michigan Completed No outcome recorded
Phase 4 NCT02944227 Mar 2016 → Feb 2017 wet macular degeneration Seoul National University Hospital Completed No outcome recorded
Phase not applicable1 trial
— NCT01638858 Oct 2011 → Jul 2014 age-related macular degeneration University of Luebeck Completed No outcome recorded
Comparator or background therapy25 trials
Phase 1 NCT04884399 Comparator Jun 2021 → Dec 2022 wet macular degeneration Shanghai Biomabs Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1 NCT03312283 Comparator Dec 2017 → Apr 2019 wet macular degeneration Qilu Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1 NCT02022540 Background Feb 2014 → Mar 2016 wet macular degeneration PanOptica, Inc. Completed No outcome recorded
Phase 1 NCT02591914 Background Feb 2014 → May 2016 wet macular degeneration Retinal Consultants of Arizona Completed No outcome recorded
Phase 1/2 NCT02121353 Comparator Nov 2013 → Jan 2016 age-related macular degeneration Pfenex, Inc Completed No outcome recorded

Press releases naming this drug 96 releases

DateIssuerRelease
2026-07-20 Melt Pharmaceuticals Samsung Bioepis and Harrow Present Interim Data from a Large-Scale Post-Marketing Surveillance Study on SB11 (BYOOVIZ® / AMELIVU®), a Biosimilar to Lucentis (ranibizumab), at ASRS 2026 harrow.com ↗
2026-06-05 Lupin Limited Lupin Receives Approval from U.S. FDA for RanluspecTM (ranibizumab) Injection lupin.com ↗
2026-06-03 Xbrane Biopharma AB Xbrane Biopharma AB (publ) (“Xbrane” or “the Company”) (Nasdaq Stockholm: XBRANE) receives FDA BsUFA date of October 29, 2026 for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) xbrane.com ↗
2026-04-30 Xbrane Biopharma AB XBRANE SUBMITS RANIBIZUMAB BIOSIMILAR CANDIDATE TO FDA xbrane.com ↗
2025-12-23 Zydus Lifesciences Limited Zydus Partners with Bioeq for U.S. Commercialisation rights for NUFYMCO®, an Interchangeable Biosimilar to Lucentis®. NUFYMCO® BLA has been approved by the USFDA zyduslife.com ↗
2025-12-23 Formycon AG FDA approves another interchangeable Ranibizumab Biosimilar, Nufymco® – Strengthening US Presence with Zydus as Commercialization Partner formycon.com ↗
2025-12-23 Polpharma Biologics S.A. Bioeq and Zydus partners for U.S. Commercialisation rights for NUFYMCO®, an Interchangeable Biosimilar to Lucentis®. NUFYMCO® BLA has been approved by the USFDA polpharmabiologics.com ↗
2025-11-20 Formycon AG Ranibizumab Biosimilar Epruvy® launched in Germany formycon.com ↗
2025-11-19 Xbrane Biopharma AB XBRANE UPDATES ON TIMING FOR RESUBMISSION OF THE BLA FOR ITS RANIBIZUMAB BIOSIMILAR CANDIDATE TO FDA xbrane.com ↗
2025-10-21 Formycon AG Formycon’s FYB201/Ranivisio® sets innovative standard as Europe’s First Ranibizumab Biosimilar available in Pre-filled Syringe formycon.com ↗
2025-10-21 Polpharma Biologics S.A. Polpharma Biologics announces commercial launch of Europe’s first Pre-filled Syringe presentation of a ranibizumab biosimilar polpharmabiologics.com ↗
2025-10-20 Santen Gmbh Santen Korea Signs an Exclusive Promotion and Distribution Agreement for VEGF Inhibitors Beovu® and Lucentis® in the Republic of Korea santen.com ↗

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 36 sources stand behind the page.

FieldValueCited text
Known as Lucentis “A 24 Month Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF-BB Pegylated Aptamer) Regiment Administered in Combination With Avastin®, Eylea®, or Lucentis®) During the...” NCT02214628 ↗
35

“intravitreal injection of Avastin, Lucentis, and Macugen for wet age-related macular degeneration, retinal vein occlusion, and diabetic macular edema” NCT01640171 ↗

“Subjects will receive monthly intravitreous injections of Avacincaptad Pegol in combination with Lucentis, Avastin or Eylea.” NCT02397954 ↗

NCT00455871 ↗

NCT03203447 ↗

NCT01638858 ↗

NCT00467935 ↗

NCT02033031 ↗

NCT03097068 ↗

NCT05003245 ↗

NCT03312283 ↗

Show 25 more sources

Known as Ranibizumab “Lucentis® (ranibizumab) 0.5mg via intravitreal injection every one month during the loading phase, and intervals of one month based on criteria during the PRN phase.” NCT04857177 ↗
5

“Comparing the Efficacy and Safety of BAT5906 Versus Ranibizumab (Lucentis®) in Patients With Diabetic Macular Edema (DME)” NCT07515079 ↗

“Lucentis (Ranibizumab) plus reduced fluence Photodynamic Therapy With Visudyne” NCT00455871 ↗

“Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks” NCT06305416 ↗

“intravitreal injection Lucentis (ranibizumab)” NCT00467935 ↗

“Lucentis (Ranibizumab)” NCT01638858 ↗

Known as RBZ “LUCENTIS® (0.5 mg ranibizumab or RBZ, an anti-neovascular VEGF-A inhibitor, Novartis Pharmaceuticals Canada Inc.) was the first approved medical treatment for DME” NCT02684084 ↗
Action Inhibit “anti-vascular endothelial growth factor (VEGF) therapy” NCT02397954 ↗
Modality Monoclonal antibody “anti-VEGF recombinant humanized monoclonal antibody fragment” NCT05003245 ↗
Route Intravitreal “Lucentis intravitreal injection” NCT00455871 ↗
Target VEGFA “LUCENTIS® (0.5 mg ranibizumab or RBZ, an anti-neovascular VEGF-A inhibitor, Novartis Pharmaceuticals Canada Inc.) was the first approved medical treatment for DME” NCT02684084 ↗