Restore sight against all odds


In the practice of medicine, we are trained to always put the patient first. But sometimes we stray from the ideals with which so many optometrists launch their careers. Over time, patient care can become routine, which can put us at odds with the true purpose of treating patients: caring for patients.

As an optometrist, I have had the privilege of working in both practice and industry. While each pathway has its own unique functions and challenges, both share a common denominator: the responsibility to provide the highest level of patient care.

I’ve always had a keen interest in innovating the medical model of care and advancing clinical science, but the idea of ​​“servitude” has held true to me since I was very young. I come from a family of doctors; I used to watch my mother, a pediatrician, travel the villages of Albania to treat sick and underserved children. Since then, I have felt a call to serve that has permeated all aspects of my personal and professional life.

Cell therapy

At the end of 2019, I had the opportunity to design an exploratory clinical trial for Aurion Biotech, a company whose mission is to restore vision to all those who need it by developing a platform of innovative, accessible and game-changing advanced therapies. the life. Our first candidate, a patented cell therapy treatment for corneal endothelial disease, was developed by Professor Shigeru Kinoshita, MD, PhD, and colleagues at Kyoto Prefectural Medical University in Japan, and later acquired by Aurion . I jumped at the chance to serve as the architect of the first trial of this treatment outside of Japan and to be able to bring cell therapy to patients in El Salvador who need it most.

Biotechnology innovation is both nuanced and complex, with a constant need to balance speed, efficiency and results. Among several other pilots, creativity is paramount when navigating obstacles.

In order to develop a comprehensive clinical trial protocol, we had to document a procedure that, to date, had only been performed by a few Japanese ophthalmologists.

Due to the COVID-19 pandemic, we were unable to travel to Japan to observe the cell therapy procedure firsthand. Therefore, our only resources were videos of Kinoshita performing the procedure and Zoom calls with him to confirm the sequence of surgical steps.

Obstacles

To better understand patient outcomes, I began analyzing medical records and slit lamp images from Japanese trials. While we intended to follow the Japanese protocol as closely as possible, several changes were necessary for the trial in El Salvador.

Patients in Japan were followed postoperatively during a 2-week hospital stay; however, we recognized the importance of moving to an outpatient procedure to expand the accessibility of the procedure.

Within a month, we had drafted and submitted a revised protocol to El Salvador’s Institutional Review Board and set dates for the launch of the study in El Salvador. During this same period, we worked with our colleagues at the study site, Clínica Quesada, to enroll 16 patients for treatment, and engaged 4 top US eye surgeons to serve as co-investigators and perform the procedures.

Prior to departure, we were briefed on the huge category 4 hurricane Iota that was hitting Central America. The forecast track of the storm was to mirror that of a hurricane that had devastated the area 2 weeks prior. I called each of our surgeons to discuss the situation and consulted closely with our local colleagues. I knew they were excited about the potential of this treatment, but I still expected them to be hesitant to conduct a trial in the middle of a Category 4 hurricane. To my surprise, every investigator was “all in!”

We arrived in El Salvador (safely, it turns out, as the hurricane ripped through the country with minimal damage), only to deal with a myriad of logistical and customs issues getting the product delivered. laboratory equipment and biologicals into the country in time for processing. Despite significant obstacles, our team worked around the clock and everything fell into place at the 11th hour. (See Figure 1). Fittingly, the sun came out the day we performed the procedures. We named the IOTA trial to commemorate the high stakes of the storms we faced – both literally and figuratively – to bring this sight-restoring treatment to patients.

IOTA trial

Patients in this trial have bilateral corneal endothelial disease. Had they not been treated as part of the study, they likely would have faced the inevitable worsening of their condition, leading to corneal blindness. Although keratoplasty exists as an alternative, it requires 1 donor cornea for each diseased eye and considerable surgical skill to perform the transplant. Given the limited global supply of donor corneas, as well as the limited number of surgeons capable of performing complex keratoplasty, these patients would have had extremely limited access to proper care.

During part 1 of the IOTA trial, 16 patients were treated from a single donor. In the second part of our exploratory study, 34 patients were treated from another donor.

Follow-up of patients from the IOTA trial is still ongoing; however, initial results demonstrate great improvements, measured by reduced corneal edema, improved corneal clarity, and improved visual acuity. In many cases functional blindness has been reversed to functional vision.

Experience

There is 1 word I use to sum up this effort: humility. Although the clinical results we are seeing from the IOTA trial are extremely promising, the experience has had a profound personal impact on me as a person, clinician and industry leader. We have treated patients in need who otherwise would not have access to care. The El Salvador IOTA trial took me back to my roots.

It’s easy to become complacent in the United States because we have incredible care available to most patients, but there’s a big world out there full of unmet needs. It was important to remember why I am doing this work and it changed the way I practice. Having the opportunity to treat patients in El Salvador brought me back to the heart and soul of patient care.

Here in the United States, I feel a deeper sense of accomplishment when I see patients. I am more aware of the responsibility that I have to do alongside them, to be more attentive to their concerns and thus to offer better care to patients.

A new era of care

Innovation and new technologies continue to transform eye care, which means new roles for optometrists and ophthalmologists are constantly emerging. As new innovations come to market, collaboration between optometrists and ophthalmologists will become critically important.

Having spent the first half of my career primarily in private practice and the second half in industry, I find that the following few points apply equally, regardless of career path:

» The treatment of patients is the engine of innovation. Clinicians are empowered if they know what diseases to look for, understand what treatments are possible and when they are needed. Staying abreast of innovations in our field is essential to providing the best patient care possible.

» Curiosity is your best friend. The only way to know what is going to be meaningful or impactful for you in your career is to keep learning rather than focusing on 1 path. By doing so, you will have the creativity and imagination to set new and changing responsibilities in the field.

» You can do both! Optometrists can find meaningful and fulfilling work in the industry while continuing their clinical practice. In fact, involvement in both can be very rewarding and make optometrists highly valued colleagues, both in clinics and in industry.

The IOTA trial was a profound yet unique experience; however, there are moments that happen daily to remind me how lucky I am to do this job.

Maintaining my clinical practice while helping to advance transformational therapies at Aurion Biotech has given me the opportunity to see the full gamut of impact on the most important group: our patients.

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