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July 2023 Newsletter
MESSAGE FROM THE PRESIDENT
Dear Readers,
Research, education, and collaboration are key to all that we do. Last month, TGF’s 28th Annual Scientific Think Tank brought an extraordinary roster of experts together in New York to share some of the most current and important glaucoma science. This was an exciting meeting of minds covering a range of topics including drug repurposing, neuroprotection, and the need for robust health data.
During the concluding session of the Think Tank, members of our patient community spoke eloquently about their journey with glaucoma. They praised the researchers and clinicians for their outstanding efforts,
offered insight into the unmet needs of patients, and gave us actionable suggestions to improve treatment and patient care. In this and coming newsletters, we will dig deeper into the issues raised at the Think Tank. Meanwhile, you can view the conference agenda here and watch each of the six sessions via our website.
Thank you to the Think Tank Committee, sponsors Théa Pharma, Avellino, Santen, iCare, Ora Clinical, Qlaris Bio, Sight Sciences, Topcon, Triad Foundation, Glaukos, Opthalmology 360, and Research to Prevent Blindness, to our individual supporters, and to the twenty-five presenters and session moderators who made this perhaps the best think tank since its founding in 1995.
On June 10, Dr. Louis R. Pasquale was presented with the Dr. Robert Ritch Award for Excellence and Innovation in Glaucoma. Established in 2008 by The Glaucoma Foundation and named in honor of its first recipient, the founder and medical director of TGF, the Ritch Award recognizes the contributions of individuals who have played a significant and unique role in promoting the medicine and science of glaucoma. Dr. Pasquale is a distinguished member of the Foundation’s Board of Directors and co-chair of the Scientific Advisory Board and Annual Think Tank. We are proud to honor him with this award. His leadership is fundamental to our mission and we are forever grateful for his consummate expertise and his dedication to research and patient care.
On June 16, I joined Dr. Aakriti Shukla of Columbia University School of Medicine for a webinar on blindness and glaucoma sponsored by Accessible Pharmacy. A few days later, TGF presented a webinar with Drs. Gustavo De Moraes of Columbia University and Miriam Kolko of the University of Copenhagen on the side effects of glaucoma eye drops. They discussed the need for more preservative-free drops to lessen ocular surface disease, a subject of vital importance to all glaucoma patients. To that end, TGF is one of four founding members of the Preservative Freedom Coalition to Advocate for Preservative-free Eyecare, recently launched by Théa Pharma.
In this issue, you can learn about the mechanisms of clinical trials, how a patient is living with a rare form of glaucoma and serving as a patient advocate, and how you can further glaucoma research by joining “Visions for Vision” this summer.
With your ongoing support, we continue to advocate and work in partnership with others on important issues that can improve the lives of glaucoma patients.
Thank you.
Elena Sturman
DOCTOR, I HAVE A QUESTION.
What are the steps for a new (glaucoma) drug to go from the lab to patients?
Question answered by
Gustavo De Moraes, MD, PhD, MPH
Dr. De Moraes is Associate Professor of Clinical Ophthalmology at Columbia University Irving Medical Center and Chief Medical Officer at Ora Clinical, Inc.
The most important thing to remember is that the course of clinical trials from lab to patient is extraordinarily rigorous, with safety and efficacy the two key considerations throughout.
Clinical research studies usually start with some basic science research in the lab, for example, investigating a new glaucoma drug that could benefit patients in the future. But before testing the new drug on humans, the lab has to test the drug on animals (mice, guinea pigs, monkeys) for toxicity and efficacy. The FDA requires a series of preclinical studies done in accordance with good laboratory practices. The tests have to be conducted in qualified labs, with precise methodology to see if there is any effectiveness for glaucoma – e.g. does it lower IOP, does it prevent progression. Above all, we need to assess safety as we want to make sure that what we are giving animals is not making their problems worse or creating new problems. The tests on animals also help determine the initial dose to test on human patients – the highest dose that will not cause toxicity.
Once this is accomplished, Phase One of the clinical trial can begin. In this early stage, the drug is tested on a small group (ca.10 to 80 subjects, usually healthy) to judge its safety, including any side effects, and to test the maximum dosage that is tolerated. Once the drug’s safety is confirmed, Phase Two begins.
During Phase Two -- a larger study, with dozens to hundreds of glaucoma patients taking part -- we are still primarily interested in safety, including short and long-term side effects, but we can also start to study some efficacy endpoints – for example, IOP lowering, progression on OCT or visual field results. At this point, the focus and results are not yet ready for FDA approval.
Each phase builds on the results of the previous phase. The purpose of Phase Three is to evaluate how the new drug works in comparison to placebo (aka “sugar pills”) or existing medications for the same condition. Sometimes known as pivotal studies, these large, multi-center studies can involve up to thousands of participants and last several years. These are so-called randomized, masked, clinical trials with some participants receiving the new medication and others receiving placebo or an existing medication. Masking of patients and doctors is often required to make sure nobody knows who is taking the investigational drug or placebo. Rare and long-term side effects are more likely to show up during this phase. These studies, usually two independent studies, have to meet safety and efficacy endpoints and are designed for FDA approval.
In Phase Four doctors and industry study treatments that the FDA has already approved. While not required, these post-marketing studies provide additional information about the risks, benefits and best use of the drug in a much larger population in the real world after the drug has completed the other stages and has been authorized for commercialization.
COALITION TO ADVOCATE FOR PRESERVATIVE-FREE EYECARE
The Glaucoma Foundation is one of four founding members of the Preservative Freedom Coalition to Advocate for Preservative-free Eyecare, launched by Thea Pharma in May.
The initiative was created by Thea, the US subsidiary of the European independent ophthalmic-focused pharmaceutical company, to raise awareness of unmet needs in ocular surface disease and opportunities to pursue preservative-free topical ophthalmic medications.
“As medical professionals, we are the caretakers of eye health and have a responsibility to preserve and protect our patient’s vision,” said Aakriti Garg Shukla, MD, TGF Medical Advisory Board Member. “We must all do our part to prioritize lifelong ocular health. “
Joining TGF as founding members are The Intrepid Eye Society, National Medical Association Ophthalmology Section, and Real World Ophthalmology.
Formulations in many prescription and OTC eye drops continue to include preservatives. Prolonged use of these compounds has proven negative effects to the ocular surface and some anatomical structures of the eye, with some of these occurring immediately with acute signs and symptoms, and some progressing slowly over the chronic course of therapy.
“The eye care industry has a long history of using preservatives in eye drops that persists to this day,” said Susan Benton, President of Thea Pharma Inc. “The Preservative Freedom Coalition will help spark national dialogue about the need to break through our apathy and indifference, with respect to preservatives, and change habits while continuing to keep our patients' eye care as the highest priority. We look forward to working with the Coalition members to make a preservative-free future a reality."
THE 28TH ANNUAL THINK TANK
“One of the Best Ever”
On June 9th and 10th, The Glaucoma Foundation brought researchers, clinicians and – for the first time - glaucoma patients together for its Annual Glaucoma Scientific Think Tank.
Since 1995, this interdisciplinary meeting has been the premier forum for the exchange of ideas among leading scientists in diverse fields who bring their knowledge to the challenges of glaucoma and help set the course for future glaucoma research. Seventy-five participants attended the 2023 Think Tank in person in New York City; several hundred additional doctors, researchers and patients live-streamed the proceedings on Zoom.
Said Dr. Louis R. Pasquale, Co-Chair of the Think Tank and TGF’s Scientific Advisory Board: “The 28th Annual Glaucoma Think Tank Meeting was successful because the top experts motivated each other to think critically about glaucoma and patients were given a platform where they motivated us all to work harder to improve patient quality of life and prevent glaucoma blindness."
The Think Tank has significantly increased the number of people around the world working in the field. Presenters at this year’s two-day program came from Mount Sinai in New York, Johns Hopkins in Maryland, Shiley Eye Institute and the Keck School of Medicine in California, Vanderbilt University Medical Center in Tennessee, W. K. Kellogg Eye Center at the University of Michigan, Perelman School of Medicine at University of Pennsylvania, Brigham and Women's Hospital in Massachusetts, Illinois Eye and Ear Infirmary, Duke University in North Carolina, Georgia Institute of Technology, Moorfields Eye Hospital in the UK, and QIMR Berghofer Medical Research Institute in Australia.
In sessions on Day One, presenters gave talks reflecting recent and ongoing studies in four different areas. Session one’s focus was glaucoma data integration, beginning with an overview of databases available to advance glaucoma knowledge. A second session on drug repurposing for glaucoma looked at several drugs approved for other uses, and being studied to see if they reduced risk for glaucoma. Among them Metforin, a first line medication for type 2 diabetes.
The third session was on neuroprotection, including an overview of glaucoma neuroprotection agents, a consideration of why we do not yet have glaucoma neuroprotection, and a presentation on how AI might facilitate some of the challenges of randomized clinical trials in neuroprotection. The final “day one” session had three presentations on sex hormones and glaucoma. Speakers reported on various recent and ongoing studies that suggest that estrogen plays a role in glaucoma, that women with early menopause are at greater glaucoma risk and that hormone therapy may also impact risk.
PATIENTS SPEAK OUT -- THINK TANK PART TWO
“This year’s Think Tank was designed to bring patients, advocates and caregivers into the discussion on living with glaucoma,” said Elena Sturman, TGF President and CEO, during her remarks about the Foundation at the start of Day Two.
The morning began with a session on non-IOP factors in glaucoma, such as diet, hypertension and the impact of glaucoma on activities of daily life. One takeaway was that patients should limit their coffee intake to 2 cups a day. More complex was a paper on the potential relationships between blood pressure and IOP.
In the final session, three patients took the floor to talk about their moving personal glaucoma journeys and to share instructive suggestions regarding patient care and the doctor/patient relationship gleaned from their experiences as patients and patient advocates.
First up was Jahkori Dopwell Hall, a young artist and art educator who credits Dr. Robert Ritch with saving his vision when he was six weeks old and diagnosed with primary congenital glaucoma. Active within the Foundation, he is TGF’s Tik-Tok Ambassador.
The next speaker was Hillary Gordon, who in 2022 was diagnosed with severe normal tension glaucoma, having already lost almost 40 percent of her visual field. A public speaker, Hillary speaks out about how glaucoma affects patients’ everyday life, and how she manages her disease. She coaches on overcoming obstacles and achieving goals.
The final patient speaker was Amy Dixon, a visually impaired professional triathlete and member of the USA Paratriathlon National Team. Amy lost 98 percent of her vision to a rare autoimmune disease and now serves as a patient advocate.
What changes do they propose in terms of doctors providing patient-centric care?
· Because most doctors only have 10 minutes per patient, Increased usage of patient advocates/patient coaches in doctors’ offices, eye hospitals and clinics to answer questions after diagnosis, discuss expectations, make patients feel they are being heard, gain patient’s trust.
· Shifting the paradigm of how glaucoma is treated, from an appointment every six months to more frequent IOP checks using home tonometers.
· Getting doctors and insurance to come onboard and advocate for home tonometry.
· Advocating for preservative-free eyedrops.
· Discussing the patient’s expectations regarding quality-of-life priorities and expectations.
· Finding out how much the patient wants to know; not underestimating patients.
· Having patients fill out a questionnaire at beginning of appointment as a way to empower disengaged patients and make them feel feel they are being heard.
· Going where the people are – e.g. churches and community centers -- to answer questions and break through the white coat syndrome.
· Having available handouts in the office with quality of life tips on such subjects as home lighting, making your home safe from falls, driving with glaucoma.
LIVING WITH GLAUCOMA
Meet Ericka Shepard
Glaucoma is not one single disease. There are different forms and types. Some are primary glaucomas and others are secondary glaucomas– meaning they are caused by another medical condition.
Ericka Shepard, a pharmacist and Glaucoma Patient Advocate from New Hampshire, has Iridocorneal Endothelial Syndrome (ICE syndrome) glaucoma, a rare and hard to diagnose secondary glaucoma which usually presents in only one eye. With this condition, cells on the back surface of the cornea spread over the eye’s drainage tissue and across the surface of the iris. This causes an increase in eye pressure, which can damage the optic nerve.
In 30 years of practice, Ericka’s glaucoma specialist at Tufts University in Boston had only diagnosed a few cases of ICE. The fact that Ericka did not present with distortion of the iris and pupil – a visible sign of the disease - made diagnosis still more difficult.
That was nine years ago, when she was 41 years old. Ericka had gone to her local eye doctor because she was losing vision. Sometimes for only minutes, but at other times for hours, a grey curtain would descend over vision in her left eye.
She was diagnosed with glaucoma and sent to a glaucoma specialist at Tufts University who over a period of months prescribed numerous different eyedrops. But they did not lower her IOP. When she was finally diagnosed with ICE (a diagnosis that can be aided with spectral microscopy, which visualizes changes in corneal endothelium cells), an Ahmed Shunt was surgically inserted to aid drainage. The cause of ICE syndrome is not known – some think that it is virus-related. What is known is that it normally affects only one eye, often in middle-aged women, and that it appears not to be hereditary.
“My advice to all,” says Ericka, “is if you are a middle-aged woman experiencing vision problems in just one eye, have unilateral glaucoma, and no family history of glaucoma, you should ask your doctor about testing for ICE using specular microscopy.”
Ericka did well for several years, but last July her pressure rose again. “We knew the shunt was probably blocked,” she says.
“My pressure was in the 20s in the office, which was not unusually high for me, so we assumed we had some time to determine the next step. Since there aren’t many studies with ICE patients, my doctor and I decided to get multiple opinions from various specialists...one of them suggested I rent a home tonometer. The tonometer rental showed that my IOP was spiking into the 40s in the morning and sometimes in the evening. We knew we had to do something quickly with so much fluctuation and so I had a Baerveldt shunt implanted into my eye. It’s brought my pressures way down!” While I know that at some point this will probably fail due to blockage, hopefully by then something new will be available.”
Ericka’s experience with a home tonometer led to her becoming a Glaucoma Patient Ambassador. Trained as a pharmacist, she has 25 years of experience working at CVS. At one point she was District Manager for 15 stores, but she left that job when she became pregnant with twins. Today she works as a pharmacist one day a week.
As a home tonometer user, in December 2022 she received a general email from MyEYES, who were reaching out to all their patients looking for Ambassadors to provide support to new home tonometer users.
“When they receive a physician’s prescription for a home tonometer, we call the new patient immediately and stay with them all the way through their home tonometry journey. Doctors’ offices are busy, it is critical to know your disease, be compliant with your current plan, and follow diagnostic measures like renting a tonometer to improve outcomes.”
“It’s been amazing talking to hundreds of patients, all with different stories. It’s very gratifying to know that I can share my own experience and be part of their glaucoma journey.”
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