OpRegen is a Cell Therapy owned by F. Hoffmann-La Roche, and is involved in 2 clinical trials, of which 1 was completed, and 1 is planned.

OpRegen replaces the layer of damaged RPE cells that support and nourish the retina. RPE cells derived from human embryonic stem cells restore the subretinal anatomy and re-establishes the critical interaction between the RPE and the photoreceptors, which is fundamental to the eye sight.

The revenue for OpRegen is expected to reach a total of $184m through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the OpRegen NPV Report.

OpRegen was originated by Hadassah Medical Center and is currently owned by F. Hoffmann-La Roche. Lineage Cell Therapeutics is the other company associated in development or marketing of OpRegen.

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.

Lineage Cell Therapeutics Overview

Lineage Cell Therapeutics (Lineage) formerly known as BioTime, is a clinical-stage biotechnology company that develops new cell therapies for unmet medical needs. It develops products based on its core proprietary technology cell-based therapy platform. The company focuses on developing new cellular therapies for neurological conditions associated with demyelination and degenerative retinal diseases. The company lead product Renevia is developed for the treatment of facial lipoatrophy and HIV lipoatrophy. Its pipeline products include OpRegen for advanced dry age-related macular degeneration, Opc1 in acute spinal cord injury, and Vac2 for non-small cell lung cancer. The company has subsidiaries in Israel, Singapore, and the US. Lineage is headquartered in Carlsbad, California, the US.

The company reported revenues of (US Dollars) US$4.3 million for the fiscal year ended December 2021 (FY2021), compared to a revenue of US$1.8 million in FY2020. The operating loss of the company was US$48.7 million in FY2021, compared to an operating loss of US$26.5 million in FY2020. The net loss of the company was US$43 million in FY2021, compared to a net loss of US$20.7 million in FY2020. The company reported revenues of US$3 million for the third quarter ended September 2022, a decrease of 34.2% over the previous quarter.

Quick View – OpRegen

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

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

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.