Ranibizumab is under clinical development by F. Hoffmann-La Roche and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Ranibizumab’s likelihood of approval (LoA) and phase transition for Retinopathy Of Prematurity took place on 20 Sep 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Ranibizumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Ranibizumab overview

Ranibizumab (Lucentis, Patizra) is a humanized monoclonal antibody fragment and a recombinant humanized IgO 1 isotype designed to bind to and inhibit vascular endothelial growth factor (VEGF-A). It is formulated as an injection for ophthalmic intravitreal use. Lucentis is indicated for the treatment of patients with neovascular (Wet) age-related macular degeneration, macular edema following retinal vein occlusion (RVO) and diabetic macular edema. Lucentis also indicated to treat patients with visual impairment due to choroidal neovascularization (CNV) associated with causes other than neovascular age-related macular degeneration (nAMD), or secondary to pathologic myopia (PM),  for the treatment of patients with myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness, for the monthly treatment of all forms of diabetic retinopathy in people who have been diagnosed either with or without diabetic macular edema (DME), a complication of diabetic retinopathy that causes swelling in the back of the eye and also indicated for the treatment of retinopathy of prematurity (ROP) with zone I (stage1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP) disease in preterm infants, also for the treatment of proliferative diabetic retinopathy (PDR).

Lucentis was also under development for uveitic cystoid macular edema, corneal neovascularization, polypoidal choroidal vasculopathy and pterygia neovascularization.

F. Hoffmann-La Roche overview

F. Hoffmann-La Roche (Roche) is a biotechnology company that develops drugs and diagnostics to treat major diseases. It provides medicines for the treatment of cancer, other auto-immune diseases, central nervous system disorders, ophthalmological disorders, infectious diseases, and respiratory diseases. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Roche conducts research to identify novel methods to prevent, diagnose, and treat diseases. The company offers its products and services to hospitals, commercial laboratories, healthcare professionals, researchers, and pharmacists. Together with its subsidiaries and partners, the company has operations in various countries. Roche is headquartered in Basel, Switzerland.

Quick View Ranibizumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Ranibizumab
Administration Pathway
  • Intravitreal
  • Subconjunctival
  • Topical
Therapeutic Areas
  • Ear Nose Throat Disorders
  • Metabolic Disorders
  • Ophthalmology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.