Nacuity Pharmaceuticals, Inc. is a newly formed pharmaceutical company whose mission is to develop a breakthrough treatment for retinitis pigmentosa (“RP”) and potentially other ophthalmological indications. Based on encouraging data for use of NACA to treat RP generated by animal studies in the laboratory of Dr. Peter Campochiaro at the Wilmer Eye Institute, Nacuity will seek to complete the pre-clinical work necessary to enable the filing of an Investigational New Drug Application (IND) with the FDA.
If Nacuity’s first clinical trial is successful, Nacuity and the FDA then would agree on the design of large-scale studies of NPI-001 to gather more information about safety and effectiveness. Analyses of the animal and human data and information about how the drug behaves in the body and about how it is manufactured then would be submitted to the FDA as part of a New Drug Application (“NDA”). The FDA generally requires six to ten months to review an NDA.
Nacuity has assembled an accomplished team and has received significant financial and technical support from the Foundation Fighting Blindness (FFB). The mission of FFB is to drive research providing prevention, treatments and cures for people affected by blinding retinal diseases. Over the last 46 years, FFB has invested nearly $700 million in this effort. FFB is a significant supporter of Dr. Campochiaro’s research and has committed to fund a substantial portion of Nacuity’s Phase 1 and Phase 2 trials through a milestone-based matching program grant to Nacuity in support of our NPI-001 development program.