Emery Pharma and Rayner Announce Publication of a Successful Validation of Bioanalytical Method for Quantifying Ketorolac in Human Vitreous and Aqueous Humor Using a Surrogate Matrix of Human Plasma, in Accordance with ICH M10 Guidelines
Emery Pharma, a leading contract research organization specializing in bioanalytical method development and validation, has partnered with Rayner to develop and validate a novel bioanalytical method for measuring ketorolac concentrations in ocular fluids. This validated method played a crucial role in a recent clinical study investigating OMIDRIA® (phenylephrine 1.0%/ketorolac 0.3%) and its ability to penetrate aqueous and vitreous humor postoperatively.
OMIDRIA®, widely used in cataract surgery to prevent intraoperative miosis and reduce postoperative pain and complications, had previously been studied in preclinical animal model, but human pharmacokinetic data remained limited. Thus, this recently published study plays a crucial role in bridging the gap between preclinical and clinical pharmacokinetic data, providing valuable insight into OMIDRIA®’s ocular penetration in humans. Further, a key challenge in studying human ocular pharmacokinetics is the limited availability of aqueous and vitreous humor samples. To address this, Emery Pharma developed and validated an innovative bioanalytical approach using human plasma as a surrogate matrix to quantify ketorolac levels in ocular fluids.
“Our expertise in method development and validation ensures adherence with ICH M10 Bioanalytical Method Validation Guidelines, providing robust and reliable data for ophthalmic drug research,” said Dr. Ron Najafi, CEO of Emery Pharma. “This study underscores our commitment to supporting pharmaceutical innovation and advancing ophthalmic therapeutics.”
Rayner, a global leader in ophthalmic solutions, recognizes the importance of this breakthrough in understanding OMIDRIA®’s pharmacokinetics. “The ability to measure ketorolac concentrations in ocular fluids with validated accuracy marks a significant step forward in optimizing ophthalmic drug efficacy and patient outcomes,” said Tim Clover, CEO of Rayner.
This collaboration highlights Emery Pharma’s expertise in regulated bioanalysis, method validation, and compliance-driven research-critical components in the advancement of ophthalmic therapeutics.
For access to the full article visit: https://www.tandfonline.com/doi/full/10.1080/20565623.2025.2476866 or if you would like more information about Emery Pharma’s bioanalytical capabilities or to discuss potential collaborations, please visit emerypharma.com or contact Mr. Chris Purcell, Business Development Manager, at info@emerypharma.com.
About Emery Pharma
Emery Pharma is a GLP-compliant, FDA-registered, and DEA-licensed contract research organization specializing in bioanalysis, method development, validation, and stability testing for pharmaceuticals, biologics, and medical devices. With cutting-edge instrumentation, including LC-MS/MS, high-resolution mass spectrometry, and NMR, Emery Pharma provides comprehensive analytical solutions to support drug development and regulatory compliance.
About Rayner
Since the implantation of the first Rayner intraocular lens by Sir Harold Ridley in 1949, Rayner has had the goal to improve vision and restore sight worldwide. Today, Rayner’s mission remains to deliver innovative and clinically superior ophthalmic products that respond to the expectations of global customers to improve the sight and quality of life of their patients.
Headquartered in Worthing, United Kingdom, Rayner markets its medical devices, pharmaceuticals, and digital solutions worldwide in over 80 countries, including direct sales teams in the United Kingdom, Eire, USA, Canada, Brazil, India, Poland, Australia, Germany, Austria, Switzerland, France, Italy, Spain, and Portugal.
Media Contact:
Chris Purcell
Business Development Manager
Emery Pharma
Email: info@emerypharma.com
Website: emerypharma.com
Nicolee Schulze
Sr. Director, OMIDRIA Brand Lead
Rayner
Email: nicoleeschulze@rayner.com
Website: www.rayner.com
