OpRegen is under clinical development by F. Hoffmann-La Roche and currently in the Phase II 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 OpRegen’s likelihood of approval (LoA) and phase transition for Dry (Atrophic) Macular Degeneration took place on 07 Nov 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.

In addition, the same event on 07 Nov 2022 increased OpRegen’s LoA and PTSR for Geographic Atrophy.

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

OpRegen overview

OpRegen is under development for the treatment of geographic atrophy, severe dry-form of age-related macular degeneration (AMD). The drug candidate is administered into the sub-retinal space during an intraocular injection. It is a suspension of retinal pigment epithelial (RPE) cells which are embryonic stem cell-derived RPE cells.

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 OpRegen LOA Data

Report Segments
  • Innovator
Drug Name
  • OpRegen
Administration Pathway
  • Intraocular
Therapeutic Areas
  • Ophthalmology
Key Developers
Highest Development Stage
  • Phase II

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.