For years ophthalmologists have been using the drug mitomycin C off-label to modulate wound healing during eye surgeries. In glaucoma filtering surgery, it’s known to prevent post-operative scarring and reduce the risk of surgical failure. But it’s tricky to work with, and until recently no one had taken on the work of getting it FDA approved for ophthalmic indications.
“It’s cytotoxic, carcinogenic, and a difficult molecule to work with,” said Ed Timm, the president of Mobius Therapeutics, which took on that challenge six years ago. “It’s very unstable. If you refrigerate it and light-shield it, it has a max shelf life of two weeks.”
St. Louis-based Mobius has focused on creating and commercializing an ophthalmic formulation of mitomycin that is sterile, doesn’t require refrigeration, has a shelf life of up to 24 months and has guaranteed potency.
“It’s important to differentiate the substance from the product, Mitosol,” Timm said. “Making it a product took six years and a full regulatory review.”
The last piece of Mobius’ kit for glaucoma surgery was approved by the FDA in February, and the company shipped its first batch in July.
It’s now awaiting regulatory approval of the drug for use in two other ophthalmic applications, pterygium surgery and surface ablation, both with orphan drug designation.
Timm said the company had just closed a round of equity financing from angel investors but declined to say how much was raised. An SEC filing from last week indicates a target of $5 million.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Glaucoma is the second-leading cause of blindness in the United States and is thought to affect 2.2 million Americans, but at least half of them are thought to remain untreated. Glaucoma drugs make up the largest segment of the ophthalmology therapeutics market, which is valued around $10 billion globally and dominated by Big Pharma companies. Surgery is typically a final step of intervention following drugs and laser surgery.
Mobius is housed at the Center for Emerging Technologies in St. Louis.
[Photo from stock.xchng user boogy_man]
