December 7, 2021
O.Y.E. Therapeutics announces successful pre-IND meeting with FDA
CROWN POINT, Ind. -- O.Y.E. Therapeutics, a clinical-stage pharmaceutical development company with a drug targeted at expediting emergence from anesthesia, has announced a successful pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration.
A pre-IND meeting provides an opportunity for a drug development company and the FDA to discuss the drug's development plan and to obtain the agency's guidance for clinical studies of the company's new drug candidate.
"We are grateful for the guidance from the FDA as we move into our next phase of research," said Brett Dines, O.Y.E. CEO. "They were helpful as to what they wished to see regarding the safety profile of our product. They also offered feedback that our trial design would be effective at demonstrating efficacy in their eyes.
"They articulated a path for development that is not at odds with our vision and desired timeline. It gives us more confidence in our approach to better clinical outcomes, enhanced patient safety and an improved patient experience."
Research shows delayed emergence from anesthesia results in billions of dollars in avoidable expenses, millions of extra days in the hospital and, most urgently, 32,000 lives lost on an annual basis. The drug product from O.Y.E.'s lead clinical program helps patients emerge more quickly from anesthesia, especially following long and complicated surgical procedures or in patients who are more at risk — those diagnosed with obstructive sleep apnea, older patients or obese patients — for complications during this important clinical process at the end of a surgical case.
O.Y.E. Therapeutics is located in the Purdue Research Park of Northwest Indiana. Dines and chief operating officer Michael Hicks are Purdue University alumni.
About O.Y.E. Therapeutics Inc.
O.Y.E. Therapeutics is a clinical-stage pharmaceutical development company with multiple therapy programs. The organization focuses on closing gaps in care pertaining to respiratory and cognitive support. Their solutions are aimed at some of the most pervasive and pressing issues in health care. Examples include:
- Improving procedural safety for an aging population driving an increased demand for surgery.
- Strengthening emergent care related to the opioid crisis.
- Supporting rescue operations and the ability for self-preservation following traumatic injury.
Purdue Research Foundation contact: Steve Martin, email@example.com
O.Y.E. Therapeutics contact: Mike Hicks, firstname.lastname@example.org