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Technology Overview

OHSU # 1749 — Three-dimensional Anterior Chamber Angle of the Eye Measurements with OCT

Technology Overview

The two broad patient populations most suited for the OCT 3D Angle Measurement Test are: 1) individuals that require angle measurement tests in routine eye exams in substitution for gonioscopy, and 2) individuals that require treatment monitoring, namely individuals with angle closure glaucoma or patients that have undergone glaucoma surgery.

Anterior chamber angle measurement of the eye will vary depending on the landmarks in the eye used and the irregularity of the surface lining of the relevant tissue. Currently, gonioscopy is the most widely practiced test for this measurement. However, it is difficult to perform correctly, requires additional eye specialist training, and is not quantifiable. This OCT software technology enables the precise 3D angle measurement from essentially all major, pertinent landmarks in the eye. By doing so, it enables a more reliable, quantifiable angle measurement test that is both non-invasive and non-contact in nature.

Market Overview

Patient Type

2010

2020

ACG, U.S. only

780,000

1,026,000

U.S. Patients Undergoing

Glaucoma Surgery /Year that will require OCT monitoring¹

3,680

4,841

Ongoing Checkups in the US

10,474,000

11,584,000

TOTAL US MARKET PER YEAR

11,257,680

12,614,841

Asians with ACG (Int’l, includes U.S.)

6,430,000

8,460,000

Incidence of Angle Closure Glaucoma (ACG)

According to one study, there will be 60.5 million people with Open Angle Glaucoma and ACG in 2010, increasing to 79.6 million by 2020. Of these, 26% will have ACG.² Incidence rates are higher among Asians, which account for 6.43M in 2010 and projected to be about 8.46M in 2020, though exact figures vary considerably per study. As to the US, another study indicates that "[m]ore than 2 million people in the United States have primary open-angle glaucoma [as of late 2009] and that number is expected to exceed 3 million by 2020."³

Number of people with ACG, 2010

Total ACG

Lower CL

Upper CL

% World ACG

China

7,473,195

4,419,269

13,216,902

47.5

India

3,733,620

2,630,886

5,510,142

23.7

SE Asia

2,141,584

1,246,325

3,852,149

13.6

Europe

1,371,405

1,310,861

1,434,702

8.7

Latin America

322,804

308,667

337,581

2.1

Japan

278,763

171,811

456,753

1.8

Africa

245,844

235,143

257,029

1.6

Middle East

177,869

170,124

185,964

1.1

World

15,744,965

10,493,085

25,251,221

Ongoing Checkups in the US

Early detection, through regular eye exams, is the key to protecting vision from damage caused by glaucoma. A complete eye exam includes five common tests to detect glaucoma. One such test is gonioscopy. For the reasons stated above, the OCT 3D Angle measurement test should replace gonioscopy. According to experts in the field, it is important to examine a patients eyes through gonioscopy as follows:

• before age 40, every two to four years

• from age 40 to age 54, every one to three years

• from age 55 to 64, every one to two years

- after age 65, every six to 12 months

We assumed the level of compliance was only one eighth of that recommended. For instance, individuals between 40-54 should be examined at least once every three years, but we multiplied the 1 out of 3 by 1/8 such that only 1/24th of individuals of that age group engage in a screening test per year. For individuals under 40, we assumed only 1/15th compliance rate of that recommended and for under 14, no scans at all. This leads to more realistic projections.

Inventors:

Patents

Issued United States 9,579,016

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