Roche Licenses Rights to Experimental Eye Cell Therapy

The drug is in early clinical testing for an eye condition that can cause blindness but doesn’t have an approved treatment.

Cellular therapies such as Lineage’s drug, called OpRegen, belong to an emerging class of treatments made from cells engineered in a lab to fight a disease and then placed in the patient.

Genentech, which has two partnerships developing experimental cell therapies for cancer, wants to add more of the drugs to its pipeline for eye and other diseases.

“This deal and this collaboration represents what we believe could be the tip of the spear in our efforts in cell-based therapies,” Tom Zioncheck, Roche’s head of neuroscience, ophthalmology and rare-diseases pharma partnering, said in an interview.

It could also help Genentech keep its foothold in the lucrative market for eye and other sensory-organ drugs. The market had $24 billion in global sales in 2019, according to the most recent estimate by market-research firm EvaluatePharma.

Roche reported about $1.1 billion in U.S. sales for Lucentis, a drug treating a related degenerative eye disease, during the first three quarters of this year.

In September, the Food and Drug Administration approved a competing version of Lucentis, a so-called biosimilar made by

Biogen Inc.

and Samsung Bioepis Co., which the companies have said they could start selling in June.

A Genentech spokesman said the company is focusing and investing heavily in ophthalmology and said it won FDA approval for an eye implant treating the same disease as Lucentis and has another investigational eye treatment under review with the FDA that it expects will be approved next year.

Lineage has been developing OpRegen to treat a condition known as advanced dry macular degeneration with geographic atrophy.

In patients with the disease, cells used for reading and seeing faces die off and large sections of the retina stop functioning. The condition is a leading cause of blindness in the world, affecting tens of millions of people.

“Being a global unmet need, it made a lot of sense for us to partner with Genentech, which brings the resources and capabilities to move quickly and globally,” Lineage Chief Executive

Brian Culley

said in an interview.

OpRegen is made from the type of retina cells that dry macular degeneration patients lose. The engineered cells are transplanted into the area of the eye where they are needed.

Genentech was interested in Lineage’s treatment, Mr. Zioncheck said, because of its potential to not only preserve vision but also restore it.

The drug is currently in Phase 1/2a safety and efficacy testing. Officials at both companies declined to estimate when more advanced studies might take place but said they are working as quickly as possible to bring the drug to market.

Under the terms of the deal, Lineage can receive up to $620 million in additional development, approval and sales milestone payments, according to the companies.

Write to Felicia Schwartz at [email protected]