Competitive Advantage
MacuCLEAR has significant advantages compared to related compounds currently in the development pipeline. Most are 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 to do so because of safety findings during the clinical trial process, when toxicities or adverse drug reactions related to the new drug are uncovered.
The safety profile of our compounds, since they are already approved and on the market for other diseases is generally well known and understood. MacuCLEAR's initial drug candidates (new uses for existing drugs) 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 four experienced life science and pharmaceutical industry executives and professionals. Combined, the team has commercialized over a dozen products—including ophthalmic pharmaceuticals— resulting in billions of product revenue.