TREATMENT AND PREVENTION OF AGE-RELATED EYE DISEASES

Age-Related Eye Disease Overview

Four of the leading age-related eye diseases are glaucoma, macular degeneration, cataracts, and diabetic retinopathy.

Glaucoma is a condition in which there is a build-up of fluid in the eye that increases pressure and damage to the retina and the optic nerve. The retina is the layer of nerve tissue inside the eye that senses light and sends images along the optic nerve to the brain. Glaucoma damages the optic nerve and cause loss of vision or blindness. Statistics suggest that over 3 million people in the US, alone, have glaucoma. (The Eye Diseases Prevalence Research Group 2004).

Regarding macular degeneration,  the National Cancer Institute, age-related macular degeneration (AMD) and cataract are leading causes of visual impairment and blindness in the United States. Approximately 1.7 million Americans have some form of AMD, and approximately 100,000 are blind from the disease. The NEI estimates that there are 1.5 million surgeries for cataract each year in the U.S. Based on many clinical studies, the frequency of both diseases increases dramatically after age 65.

According to the American Optometric Association, cataracts are a leading cause of visual impairment among aging Americans and a key quality-of-life issue. Over 2 million procedures are done each year to address cataracts.

Finally, diabetic retinopathy (DR) is a leading cause of vision-loss globally. Of an estimated 285 million people with diabetes mellitus worldwide, approximately one third have signs of DR and of these, a further one third of DR is vision-threatening DR, including diabetic macular edema (DME). The identification of established modifiable risk factors for DR such as hyperglycemia and hypertension has provided the basis for risk factor control in preventing onset and progression of DR. Additional research investigating novel risk factors has improved our understanding of multiple biological pathways involved in the pathogenesis of DR and DME, especially those involved in inflammation and oxidative stress. (Lee 2015)

Clinical Trial Design

Matrix Biomed, Inc. is developing a protocol directed to the treatment and prevention of glaucoma.

  1. Objective: Treatment and Prevention of Glaucoma
  2. Stage: Phase I
  3. Study Population: Healthy human volunteers
  4. Number of Patients: 20 patients (Patients are their own control; TEMPOL ophthalmic solution v Placebo)
  5. Primary Endpoint: Safety and tolerability.
  6. Secondary Endpoints:
    1. Reduction in interlocutory pressure (Tonometry)
    2. Changes in Perimetry (field of vision)
    3. Changes in vision (Snellen Chart)

Pharmacokinetic data will be analyzed both locally and systemically after topical administration.

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