Competitive Advantages in treating dry AMD
MacuCLEAR has significant advantages compared to competition currently in the development pipeline.
The compelling competitive advantage of MacuCLEAR is the way MC-1101 treats and prevents the progression of dry AMD. MacuCLEAR believes the primary cause of AMD is aging, and aging can cause a reduction of blood flow as in atherosclerosis. When a reduction of blood flow occurs in the back of the eye, metabolic waste products naturally occurring from the time we are born, can accumulate. Continued accumulation can cause a rupture of the Bruch's Membrane. New blood vessels being formed whenever the body experiences a reduction of blood flow can now get through this critical blood barrier, and bleed into the retina tissues, causing the wet form of AMD, and blindnes.
All competitive efforts addressing dry AMD are attacking one or the other of the metabolic pathways. Since there are many of these pathways, no one drug has demonstrated it can stop the accumulation of all of them. All competitive efforts taking this approach to solve the dry AMD problem have failed to go beyond Phase II trials due to failure to meet primary study enpoints. Please visit our technology page to learn more about MC-1101's mechanism of action.
Other advantages come from the fact most competitors are developing new chemical entities (NCEs) and as such will be subject to the full FDA approval process required under a 505(b)1 new drug approval (NDA) application. This process is very complex. Most drugs that fail, often do so late in the clinical process because of safety findings when toxicities or adverse drug reactions related to the new drug are uncovered.
The safety profile of our lead compound MC-1101 is already approved and on the market for other diseases is generally well known and understood. MacuCLEAR's initial drug candidate ( a repurposed drug, i.e., new use for an existing drug) will be subject to the abbreviated FDA approval process for a 505(b)2 NDA application thereby reducing the overall amount of work and associated time and cost required for FDA approval.
Efficient Drug Development
MacuCLEAR has selected appropriate development partners and resources to outsource select preclinical, clinical and regulatory activities (e.g. IND preparation). The outsourcing model is a common approach in the drug development industry, which provides key resources when required for a specific duration or scope. This strategy allows for targeted and planned resource utilization, and has enabled MacuCLEAR to make substantial development progress while reducing headcount, which in turn reduces company overhead and burn rate.
Experienced Life Science Industry Management
MacuCLEAR's management team is comprised of experienced life science and pharmaceutical industry executives and professionals. Combined, the team has commercialized dozens of products—including ophthalmic pharmaceuticals— resulting in billions of product revenue.