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Perhaps you heard that ACU-4429, the investigational oral treatment for dry age-related macular degeneration developed by Acucela and Otsuka Pharmaceutical Ltd. received “Fast Track” designation from the U.S. Food and Drug Administration (FDA).
Let me tell you why this designation is so important to patients.
The goal of the “Fast Track” designation is simple: to help ensure that important new drugs get to patients as quickly as possible, without compromising safety or effectiveness. The designation facilitates development and expedites review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Drugs on the “Fast Track” may be eligible for priority regulatory review by the FDA, and thus become available to patients many months, or even years, earlier than they would without the designation.
ACU-4429, currently in Phase 2 clinical trials, is one of the only treatments in development that works to slow the eye’s visual cycle for processing light. We believe that by slowing this cycle, ACU-4429 has demonstrated the ability to decrease the levels of toxic by-products in the eye and thereby potentially stop the advance of dry AMD, a degenerative disease that affects the part of the retina responsible for fine visual acuity and color vision.
Everyone at Acucela believes that ACU-4429 may represent a new approach to treating dry AMD and other degenerative eye disease. The “Fast Track” designation is critical for patients now losing their vision to the disease because it can accelerate our clinical programs and allow us to bring ACU-4429 to patients faster than we otherwise would have otherwise been possible.
For more about the “Fast Track” designation and the FDA’s other approaches to speeding drug development, you can visit the FDA Web site.
I look forward to keeping you updated on the progress of ACU-4429!
