EyeCRO recently requested and conducted a pre-IND meeting with the US FDA to discuss the nonclinical and clinical development plans for CsA-MiDROPS™ to treat Dry Eye Disease. The agency was supportive of the project and agreed that the proposed nonclinical and CMC studies would allow entry into a phase II clinical trial. Also discussed was the potential and required clinical endpoints for examining CsA-MiDROPS™ in patients with uveitis. EyeCRO expects to file the IND by Q1 of 2020 and begin enrolling patients.
Preclinical Ophthalmic Contract Research