Allergan, Inc. has entered Phase IIb clinical trials for experimental drug AGN-150998 as a potential treatment for wet age-related macular degeneration (AMD), specifically as an injectable medication designed to inhibit abnormal retinal blood vessel growth (i.e., an anti-VEGF treatment, explained below). Allergan, Inc. is a multi-specialty health care company focused on discovering, developing, and commercializing innovative pharmaceuticals, biologics, and medical devices.
The REACH Study
This ongoing clinical trial, known as the REACH Study, is sponsored by Allergan to determine:
- the safety of AGN-150998;
- how well AGN-150998 is tolerated;
- how long the effects of AGN-150998 will last;
- the effectiveness of AGN-150998 compared to Lucentis, an FDA-approved treatment for wet AMD.
About Age-Related Macular Degeneration (AMD)
In wet macular degeneration, the choroid (a part of the eye containing blood vessels that nourish the retina) begins to sprout abnormal blood vessels that develop into a cluster under the macula (called choroidal neovascularization).
The macula is the part of the retina that provides the clearest central vision. Because these new blood vessels are abnormal, they tend to break, bleed, and leak fluid under the macula, causing it to lift up and pull away from its base. This damages the fragile photoreceptor cells, which sense and receive light, resulting in a rapid and severe loss of central vision.
Anti-Angiogenic and anti-VEGF Drugs
Angiogenesis is a term used to describe the growth of new blood vessels and plays a crucial role in the normal development of body organs and tissue. Sometimes, however, excessive and abnormal blood vessel development can occur in diseases such as cancer (tumor growth) and AMD (retinal and macular bleeding).
Substances that stop the growth of these excessive blood vessels are called anti-angiogenic (anti=against; angio=vessel; genic=development), and anti-neovascular (anti=against; neo=new; vascular=blood vessels).
The focus of current anti-angiogenic drug treatments for wet AMD is to reduce the level of a particular protein (vascular endothelial growth factor, or VEGF) that stimulates abnormal blood vessel growth in the retina and macula; thus, these drugs are classified as anti-VEGF treatments. At present, these drugs are administered by injection directly into the eye after the surface has been numbed.
More About Clinical Trials
Most clinical trials are designated as Phase I, II, or III, based on the questions the study is seeking to answer:
- In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe and effective dosage range, and identify possible side effects.
- In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to determine if it is effective and to further evaluate its safety.
- In Phase III studies, the study drug or treatment is given to even larger groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
- In Phase IV studies, after the Food and Drug Administration (FDA) has approved the drug, continuing studies will determine additional information, such as the drug’s risks, side effects, benefits, and optimal use.
VisionAware will provide updates on this important drug development research as they become available. You can learn more about locating and understanding clinical trials at A New Website from the National Institutes of Health: Clinical Research Trials and You.
Additional sources: MarketWatch; Retinal Consultants of Arizona; University of Wisconsin Department of Ophthalmology.