Advancing Ocular Therapeutics: Real-world lessons from Ophthalmology clinical development

Ophthalmology research continues to evolve as sponsors pursue new approaches to address retinal disease, geographic atrophy, dry eye disease, progressive myopia and other vision-threatening conditions. As study designs become more complex and development programs increasingly span multiple countries and regions, sponsors face growing challenges related to recruitment, site engagement, regulatory requirements and operational execution.  

In Advancing Ocular Therapeutics: Application Book Volume 1, we share a collection of real-world ophthalmology case studies that highlight strategies used to navigate some of the most complex challenges in clinical development.  

Inside the eBook, you'll discover:

• How a sponsor achieved a critical ophthalmology data cut milestone through close CRO collaboration and operational agility.

• Approaches used to overcome recruitment barriers and regional healthcare differences in a global Phase III geographic atrophy trial.

• Insights from a senior clinical project manager on managing complex ophthalmology gene therapy studies.

• Lessons learned from accelerating ophthalmology programs across APAC markets.

• Strategies for recruiting and retaining diverse pediatric patient populations in a global progressive myopia study. 
  

These examples demonstrate how thoughtful planning, operational flexibility, close collaboration with sites and investigators and strong therapeutic understanding can help sponsors maintain momentum throughout the development journey.