FDA collaborates with academia to pursue patient-centric endpoints in glaucoma

Issue: April 2016

FORT LAUDERDALE, Fla. — Patient preferences are a part of the regulatory science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of all FDA-regulated products, Malvina B. Eydelman, MD, director of the FDA’s Division of Ophthalmic and Ear, Nose and Throat Devices, said at the American Glaucoma Society meeting.

Perspective from Kuldev Singh, MD

“Patient preferences is all about weighing the benefits and risks,” she said. “So for a low-benefit, high-risk device, the product may only get approved if significant evidence exists that at least a subset of patients would trade the risk for the benefit.”

Malvina B. Eydelman

At Johns Hopkins University and University of California, San Francisco/Stanford, two of four recently established Centers of Excellence in Regulatory Science and Innovation (CERSI), collaboration with the FDA is underway to determine patient preferences in glaucoma treatment with a focus on minimally invasive glaucoma surgery (MIGS) devices and to begin development of patient-reported outcome measures to assess health-related quality of life in mild to moderate glaucoma patients.

“We are incredibly fortunate to be able to formulate the first bicoastal CERSI collaboration between FDA and Johns Hopkins and UCSF/Stanford,” Eydelman said.

At Johns Hopkins University, the project will aim to determine patient preferences in glaucoma treatment with a focus on MIGS devices. At Stanford, patient-reported outcome measures will be developed to assess health-related quality of life in mild to moderate glaucoma patients. – by Patricia Nale, ELS

Disclosure: Eydelman reports no relevant financial disclosures.

Perspective

Kuldev Singh, MD

Dr. Eydelman’s presentation at the AGS meeting highlighted the CERSI (Centers of Excellence in Regulatory Science and Innovation) collaboration between the Johns Hopkins and UCSF/Stanford centers. As a participant in this collaboration, I have seen firsthand the commitment of Dr. Eydelman and her FDA team in supporting regulatory science to assess the patient’s perspective in the rapidly growing field of minimally invasive glaucoma surgery (MIGS). The AGS is supporting the CERSI centers with a 12-member committee focusing on patient preferences and outcomes chaired by Dr. George Spaeth of the Wills Eye Hospital.

These projects are the latest in a series of AGS-FDA collaborations, including a joint MIGS workshop held in conjunction with the AGS Annual Meeting in 2014, which resulted in a published MIGS Special Commentary and was subsequently followed by the issuance of FDA guidelines for Premarket Studies of Implantable MIGS devices on December 15, 2015.

The first bicoastal CERSI collaboration described by Dr. Eydelman promises to use state of the art patient preference and outcome methodologies to advance our understanding of patient perspectives relating to MIGS procedures.

References:

Caprioli J, et al. Ophthalmology. 2015;doi:10.1016/j.ophtha.2015.02.029.

Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices: Guidance for Industry and Food and Drug Administration Staff. http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm433165.pdf.

Kuldev Singh, MD

Palo Alto, Calif.

Disclosures: Singh reports he is a consultant for Alcon, Allergan, InnFocus, Ivantis and Transcend.