Journey of new drug delivery system from idea to clinical trial involves multiple resourcesJuly 28, 2014
Imagine yourself at age 80, fumbling for the small vial of eye-drops your ophthalmologist prescribed for your glaucoma. It’s 5 p.m., you can’t remember whether you put them back in the bathroom or the dining room after your last application, and you worry that your shaking hands will once again leave eye-drops on your cheeks instead of in your eyes.
Molly Walsh, MD, an ophthalmologist and researcher at Duke, wants to make life easier for you. Through collaborations with Jennifer West, PhD, professor of engineering at Duke, and fellow Duke ophthalmologist Stuart McKinnon, MD, PhD, she has created a Retroject device (known as RJT1125) that stabilizes the eyeball and allows a glaucoma drug to be injected into the veins near the iris. The injection includes tiny nanoparticles designed to release their payload of medication continuously for several months, eliminating the need for daily eye drops.
The research for the Retroject drug delivery system recently received approval to move from laboratory studies in animals to studies with humans.
Assistance Makes Journey Faster
The RJT1125 is the size of a half dollar and fits perfectly over the patient’s eye to stabilize the eye for the injection. Although blood in the vein is normally flowing away from the eye, by using the Retroject to put gentle pressure on the vein, the medicine flows in a retrograde motion, ending up inside the eye. The entire process can take less than a minute during a regular eye check-up by an ophthalmologist.
But the journey from idea to clinical trial has taken much longer.
It began three years ago with an idea bandied about by Walsh and her mentor at the Duke Eye Center, the late David Epstein, MD, chair of the Department of Ophthalmology.
Along the way, Walsh has received help and resources, many made available through the Duke Translational Medicine Institute (DTMI), whose mission is to speed up the translation of laboratory science into clinical care.
In 2013, Walsh and West received a grant through the Duke/Coulter Translational Research Partnership, which supports collaborative research projects involving biomedical engineering and clinical medicine at Duke. This grant provided financial support and free advice and direction on regulatory pathways and commercialization strategies. Through the Coulter award, Duke provided West and Walsh with a project leader, Kristi Viles, PhD, to help the researchers along the path toward success. This service is offered through the Duke Translational Research Institute (DTRI).
“The infrastructure and guidance Kristi provides are immensely helpful,” Walsh said. “This has pushed our technology forward in ways I could not have done alone.”
The Regulatory Affairs Core of DTMI also provided vital advice to help the researchers navigate the sometimes confusing world of the Federal Drug Administration (FDA). After discussing the project with Walsh, Jelena Berglund, PhD, assisted i preparing and submitting an investigational drug application (IND) to the FDA. “As it turns out, the future marketing application of Retroject may be considered an accessory to the drug delivery,” Walsh said.
Paying it Forward
While conducting her research, Walsh continues to practice ophthalmology with Duke Eye Center clinics in Durham and Cary. She said she didn’t enter the field of medicine expecting to be a researcher, but her appreciation for research was piqued by Epstein, a consummate mentor. Now Walsh is “paying it forward” by participating in a round table discussion at the upcoming annual meeting of the Association for Research and Vision in Ophthalmology (ARVO) in May. This discussion allows students access to seasoned researchers in order to ask questions about research as a career.
When asked what advice she is likely to give, Walsh said she wants to emphasize that researchers need to involve others.
“You have to be very passionate about what you are working on and you have to realize you are the sole engine behind the idea,” she said. “There are always hurdles that take time and effort, but if you incorporate many people who know more than you about different things, the more likely the project will move forward.”
Editor's note: A revised version of this article is available on the Pratt School of Engineering website at http://www.pratt.duke.edu/news/getting-rid-eye-drops-glaucoma