In Glaucoma, Devices Go Eye-to-Eye with Drugs

Article preview from Start Up - September, 2010

Glaucoma is of serious interest to VCs and strategic investors because of its sheer size; the disease affects 3 million people, most of them managed by drugs. Glaucoma drugs have created a $4 billion market, but have several problems, the greatest of which is non-compliance. Glaukos and other device companies aim to introduce devices that are safe and efficacious enough to compete directly with drugs, rather than standing in as an alternative to today's glaucoma surgeries reserved for end-stage patients. Glaukos recently marked a first of its kind victory; with a tiny implantable ophthalmic stent, Glaukos emerged from a PMA clinical trial that convinced an FDA panel of the benefit-to-risk ratio of its approach when used as a first-line therapy in a select group.

In Glaucoma, Devices Go Eye-to-Eye with Drugs

Article preview from Start Up - September, 2010

In the treatment of glaucoma, device start-ups began, 10 years ago, to try to fill a void between first-line drugs with compliance issues and end-stage surgeries with their safety and durability limitations. But now, device companies are going head-to-head with drugs as a first-line therapy, hoping to improve glaucoma care and create an enormous device market.

Glaucoma is a serious disease of interest to VCs and strategic investors because of its sheer size; the disease affects three million people in the US alone.

Glaucoma is deceptively complicated. On one hand, a single mechanism is implicated: high intraocular pressure (IOP), but IOP and accompanying vision loss vary dramatically among patients.

While glaucoma has created a drug market worth $4 billion, drugs have several problems, including patient non-compliance, ineffectiveness over time, and inapplicability for certain patients.

Device companies such as Glaukos are providing physicians with a variety of additional treatment options that are potentially safe and efficacious enough to compete directly with drugs.

The treatment of glaucoma, the second leading cause of blindness in the world, has the hallmark of a clinical field that's somewhat early in its development. There is no clinical consensus regarding preferred therapies, and potential treatments are few and very different from one another. Current glaucoma therapies range from drugs offering maximum safety and minimal efficacy to surgical procedures offering great efficacy but also great risks.

Ten years or so ago, start-up device companies began to see if they might not be able to bring the paradigm of interventional cardiology to glaucoma by introducing less invasive devices that would bring enough efficacy to replace or stave off the morbid surgeries that are typically only reserved for the end stages of a disease. Among the first of these start-ups were NeoMedix Inc., founded in 1993 to develop a minimally invasive device called the Trabectome, and iScience Interventional, founded in 1999, which borrowed the idea of a catheter from interventional cardiology, creating a minimally invasive entryway to enable a variety of ophthalmic procedures, beginning with glaucoma. ( See Exhibit 1.)

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iScience Interventional

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