Piloting through a pivotal study in cataract eye surgery helping patients recover their vision

Background

In order to gain FDA (Food & Drug Administration) approval, the sponsor entrusted Keyrus Life Science to conduct the pilot for this drug. Because of the Partnership built on the pilot with the sponsor, they chose Keyrus Life Science as their partner on the follow-up study.

Challenge

Lack of the sponsor's knowledge of the product in the US Marketplace and time deadlines.

Approach

Keyrus Life Science took lessons learned from the pilot to run full service for the study and preparation for FDA submission.

Key results

Supported strong regulatory documentation

Loteprednol  approved in the United States

Strong partnership advancement

Benefits

Having learned from the pilot, and having built a strong partnership, the sponsor believed Keyrus Life Science was the best CRO to manage their expanded study to gain FDA approval. The Loteprednol drug was approved in the US.

What our clients say

We developed a dynamic and trusted partnership model where Keyrus’ team was an expert extension of our clinical development team. I would work with Keyrus again with my most critical studies

Yves G. Leblanc, Ph,D., Director of operations, Sandoz