During the chronic cough study, mandated by the FDA, Company W had to incorporate an ocular substudy to monitor eye health. The primary issue was that the selected study sites, specializing in respiratory treatments, lacked the resources for ocular assessments. This led to challenges, including pushback from the sites and difficulties in coordinating with local ophthalmologists.

Company Y, a biopharmaceutical company specializing in treatments for serious diseases, faced a challenge in ensuring access to essential eye exams for pediatric patients taking its cystic fibrosis (CF) medication. Long wait times for appointments, limited Medicaid acceptance, and the vulnerability of immunocompromised patients posed significant barriers to care.

Company Z, a CRO specializing in early-phase drug development, encountered challenges during a Phase 1 study for a corneal disease treatment. The study required eye assessments at specific time points, but low patient volume and scheduling constraints made it difficult to engage local ophthalmologists. Additionally, the clinic lacked space for onsite eye assessments.

Company X, a leading Contract Research Organization (CRO) renowned for its innovative approach to clinical trials, faced a challenge during a Phase 1 study for an infectious liver disease treatment. The study protocol required monitoring for potential ocular side effects, but their clinic lacked the specialized equipment and personnel to conduct comprehensive eye exams.

Applied Genetic Technologies Corporation (AGTC), a clinical-stage biotechnology company, faced significant challenges during the COVID-19 pandemic and subsequent SKYLINE trial enrollment for X-linked Retinitis Pigmentosa (XLRP) and Achromatopsia (ACHM) gene therapy treatments. Travel restrictions and site limitations hindered patient participation and threatened trial progress.