DOD-Funded Researcher Develops Drug-Delivering Contact Lens

Featured speaker Joseph Ciolino, M.D. (Mass Eye & Ear/Harvard Medical School)

On March 17, AEVR hosted its seventh military eye trauma Congressional Briefing entitled Deployment-Related Vision Trauma Research: Development of a Contact Lens for Drug Delivery featuring Joseph Ciolino, M.D. (Mass Eye & Ear/Harvard Medical School). Funded through a Translational Research Award (see box below) from the Department of Defense’s (DOD) Peer Reviewed Vision Research Program (VRP), his research addresses a major DOD-identified gap: improved treatments for treating traumatic eye injuries, war-related injuries, and diseases to ocular structures and visual system by developing novel drug-delivery systems for the eye. The briefing was co-sponsored by Research to Prevent Blindness (RPB), Blinded Veterans Association (BVA), and ARVO (see box below).

After a welcome provided by Congressional Vision Caucus Co-Chair Congressman Gene Green (D-TX), who serves as the Ranking Member on the Health Subcommittee of the House Energy and Commerce Committee, AEVR Executive Director James Jorkasky introduced Dr. Ciolino, noting that he is a corneal specialist and clinician-scientist who treats patients with serious eye diseases and conducts research to develop new and better therapies for treating those conditions. He also recognized Dr. Ciolino as an Emerging Vision Scientist who has yet to receive his first investigator-initiated (R01) grant from the National Institutes of Health (NIH), although he has been awarded two grants from the DOD, a K08 Career Development Award from the NIH, and a Career Development Award from private funding foundation RPB.

Dr. Ciolino described why a new method for delivering drugs to the eye is a critical need by citing the limitations of other means, such as oral therapeutics and topical eye drops—the latter requiring repeated applications that can be inefficient at delivering therapeutically appropriate levels of drugs, having unpleasant side effects as a result of preservatives used, and often resulting in significant waste due to difficulty in getting drops into the eye which can also negatively impact patient compliance with a therapy regimen. Although a drug-delivering contact lens could, if successful, address these challenges, its development raises its own set of challenges: the lens must deliver drugs over an extended period of time or it would not be much more successful than repeated applications of drops; it must release a controlled amount of drug throughout its application on the eye; it must be clear so as to not impede normal vision; and it must be comfortable for the patients to wear.

A DOD-identified need in treating eye trauma is the difficulty of delivering steroids to corneas that are at risk of inflammation due to trauma from combat operations, from eye diseases such as uveitis, and from post-operative complications. Using a special polymer that is infused with medication and placed within the periphery of a contact lens, Dr. Ciolino’s project has been able to test the efficacy of the lens in delivering Ciprofloxacin, an antibiotic used to reduce ocular infections, and Dexamethasone, a corticosteroid used to reduce inflammation. The results of his work so far indicate that this corticosteroid-releasing therapeutic contact lens (TCL) is more effective than conventional eye drops at delivering drugs to the eye with fewer complications and side effects, opening the door for greatly expanded treatment options, simplified treatment regimens, and better patient compliance.

Besides the military applications of the lens, he hopes to expand it to civilian uses, such as for treating glaucoma, which also requires repeated application of eye drops necessary to control high intra-ocular pressures (IOP) which are associated with vision loss in glaucoma patients. He explained how many patients may have normal IOP when visiting a doctor—despite having the disease—leading many to believe that a patient’s compliance with their drug regimen is often better just before and after visiting their doctors, but then failing to be as disciplined in the interim between visits. A recent survey of glaucoma specialists indicates that they would use a drug-delivering contact lens to improve compliance and treatment outcomes.

The goal of this project, Dr. Ciolino added, is to develop the lens as a platform technology, making it useful in treating a wide range of ocular conditions, including retinal diseases such as Diabetic Retinopathy, that is now commonly treated using ocular injections which, beside having many of the same complications as those previously discussed, can be extremely unpleasant for the patient. By increasing drug-delivery efficiency and patient compliance while at the same time reducing side effects, the contact lens could improve outcomes in a number of diseases that often lead to major vision loss.

Dr. Ciolino concluded by briefly discussing his other DOD-funded grant which seeks to improve the success rate of artificial corneas. Artificial corneas are composed of plastic optic with a tissue carrier that contains the plastic optic. These tissue carriers often ‘melt,’ resulting in a failure of the artificial cornea and can lead to blindness. Dr. Ciolino’s project uses collagen cross-linking that aims to strengthen the carrier tissue, preventing melting and thereby improving the success rate of artificial corneas, which can be necessary when troops suffer eye trauma in combat.

With the two DOD-funded grants, Dr. Ciolino noted that his lab supports the salaries of six people.

From left: Dr. Ciolino, Cong. Gene Green (D-TX), AEVR Executive Director James Jorkasky, and ARVO Board President John Clark, Ph.D. (University of Washington)

Dr. Ciolino’s research was funded in the Fiscal Year (FY) 2013-2014 cycle of the VRP, in which 37 researchers received a total of $31.5 million to study DOD-identified vision trauma research gaps. The VRP offered two different grant mechanisms in that cycle—the Translational Research Award, with funding up to $1 million, and the Hypothesis Development Award, with funding up to $250,000. Dr. Ciolino received the former award, which supports translational research that will accelerate the movement of promising ideas in vision research into clinical applications.

Under the auspices of NAEVR, Dr. Ciolino also made Massachusetts delegation office visits:

From left: Jeanette Roberts, Ph.D., M.P.H., office of Senator Ed Markey (D-MA) with Mr. Jorkasky and Dr. Ciolino. Dr. Roberts, currently a Health Policy Fellow in Senator Markey’s office, previously served as the Dean of the University of Wisconsin–Madison School of Pharmacy.

From left: Dr. Ciolino, Mr. Jorkasky, and Melea Atkins, office of Senator Elizabeth Warren (D-MA)

ARVO Board President John Clark, Ph.D. (University of Washington) joined with BVA Board member Tom Zampieri, Ph.D. in conducting Capitol Hill visits to support the vision community’s request for VRP funding of $15 million in FY2017 Defense appropriations (the VRP has been funded in each FY2013-2016 at $10 million). Dr. Zampieri was joined by First Sergeant (Ret.) Daniel L. Wallace, Chairman of BVA’s Operation Peer Support Committee, who lost his vision in Iraq in 2003 as a result of a suicide car bomb that exploded near his unit.

From left: Dr. Zampieri, Senator Roy Blunt (R-MO), First Sergeant (Ret.) Wallace, and Dr. Clark. Senator Blunt is a Defense Appropriator.

From left: Dr. Zampieri, First Sergeant (Ret.) Wallace, Senator Claire McCaskill (D-MO), and Dr. Clark