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eye to eyeeye to eye newsnewsJuly 2023The Glaucoma Foundation | Page OneMessage FromThe PresidentDear Readers:Research, educaon, and collaboraon are key to all that we do. Last month, TGF’s 28th Annual Scienc 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 excing meeng of minds covering a range of topics including drug repurposing, neuroprotecon, and the need for robust health data.During the concluding session of the Think Tank, members of our paent community spoke eloquently about their journey with glaucoma. They praised the researchers and clinicians for their outstanding eorts, oered insights into the unmet needs of paents, and gave us aconable suggesons to improve treatment and paent care. In this and coming newsleers, 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.-connued on back pageCOALITION TO ADVOCATE FOR PRESERVATIVE-FREE EYECARETGF is one of four founding members of the Preservave Freedom Coalion to Advocate for Preservave-free Eyecare, launched by Thea Pharma in May. The iniave was created to raise awareness of unmet needs in ocular surface disease, and opportunies to pursue preservave-free topical ophthalmic medicaons. Joining TGF as founding members are The Intrepid Eye Society, Naonal Medical Associaon Ophthalmology Secon, and Real World Ophthalmology. Formulaons in many prescripon and OTC eye drops connue to include preservaves. Prolonged use of these compounds have negave eects on the ocular surface and some anatomical structures of the eye. Some of these occur immediately with acute signs and symptoms, and some progress slowly over the chronic course of therapy.“The eye care industry has a long history of using preservaves in eye drops that persists to this day,” said Susan Benton, President of Thea Pharma Inc. “The Preservave Freedom Coalion will help spark a naonal dialogue about the need to break through our apathy and indierence with respect to preservaves, and change habits while connuing to keep our paents’ eye care as the highest priority. We look forward to working with the Coalion members to make a preservave-free future a reality.”

The Glaucoma Foundation | Page TwoOn June 9th and 10th, The Glaucoma Foundaon brought together researchers, clinicians, and glaucoma paents for the 28th Annual Scienc Think Tank. Since its incepon in 1995, this interdisciplinary meeng has been the premier forum for the exchange of ideas on the problem of glaucoma among leading sciensts in diverse elds. In addion to the seventy-ve parcipants in New York City, several hundred doctors, researchers, and paents live-streamed the proceedings on Zoom.In sessions on Day One, presenters gave talks reecng recent and ongoing studies in four dierent areas. Session one’s focus was glaucoma data integraon, 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 Meormin, a rst line medicaon for type 2 diabetes. The third session was on neuroprotecon, including an overview of glaucoma neuroprotecon agents, a consideraon of why we do not yet have glaucoma neuroprotecon, and a presentaon on how AI might facilitate some of the challenges of randomized clinical trials in neuroprotecon. The nal “day one” session had three presentaons 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. “The 28th Annual Glaucoma Think Tank Meeng was successful because the top experts movated each other to think crically about glaucoma, and paents were given a plaorm where they movated us all to work harder to improve paent quality of life and prevent glaucoma blindness.” - Louis R. Pasquale, MD, FARVOeye to eye newseye to eye newseye to eye newseye to eye news

The Glaucoma Foundation | Page Threeeye to eye newseye to eye newseye to eye newsPATIENTS SPEAK OUT -- THINK TANK DAY TWOThis year’s Think Tank was designed to bring paents, advocates and caregivers into the discussion on living with glaucoma. The morning of day two began with a session on non-IOP factors in glaucoma such as diet, hypertension, and the impact of glaucoma on acvies of daily life. In the nal session, three paents took the oor to talk about their moving personal glaucoma journeys and to share instrucve suggesons regarding paent care and the doctor/paent relaonship.First up was Jahkori Dopwell Hall, a young arst and art educator who credits Dr. Robert Ritch with saving his vision when he was six weeks old and diagnosed with primary congenital glaucoma. Acve within the Foundaon, 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 eld. A public speaker, Hillary speaks out about how glaucoma aects paents’ everyday life, and how she manages her disease. She coaches on overcoming obstacles and achieving goals. The nal paent speaker was Amy Dixon, a visually impaired professional triathlete and member of the USA Paratriathlon Naonal Team. Amy lost 98 percent of her vision to a rare autoimmune disease and now serves as a paent advocate.What changes do they propose in terms of doctors providing paent-centric care? • Because most doctors only have 10 minutes per paent, Increased usage of paent advocates/paent coaches in doctors’ oces, eye hospitals and clinics to answer quesons aer diagnosis, discuss expectaons, make paents feel they are being heard, gain paent’s trust. • Shiing the paradigm of how glaucoma is treated, from an appointment every six months to more frequent IOP checks using home tonometers.• Geng doctors and insurance to come onboard and advocate for home tonometry.• Advocang for preservave-free eyedrops.• Discussing the paent’s expectaons regarding quality-of-life priories and expectaons.• Finding out how much the paent wants to know; not underesmang paents.• Having paents ll out a quesonnaire at beginning of appointment as a way to empower disengaged paents and make them feel they are being heard.• Going where the people are – e.g. churches and community centers -- to answer quesons and break through the white coat syndrome.• Having available handouts in the oce with quality of life ps on such subjects as home lighng, making your home safe from falls, driving with glaucoma.eye to eye newseye to eye newseye to eye newseye to eye news

The Glaucoma Foundation | Page Foureye to eye news She was diagnosed with glaucoma and sent to a glaucoma specialist at Tus University who over a period of months prescribed numerous dierent eyedrops. But they did not lower her IOP. When she was nally 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 aects only one eye, oen in middle-aged women, and that it appears not to be hereditary.Glaucoma is not one single disease. There are dierent forms and types. Some are primary glaucomas and others are secondary glaucomas– meaning they are caused by another medical condion.Ericka Shepard, a pharmacist and Glaucoma Paent 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 condion, cells on the back surface of the cornea spread over the eye’s drainage ssue and across the surface of the iris. This causes an increase in eye pressure, which can damage the opc nerve.In 30 years of pracce, Ericka’s glaucoma specialist at Tus University in Boston had only diagnosed a few cases of ICE. The fact that Ericka did not present with distoron of the iris and pupil – a visible sign of the disease - made diagnosis sll more dicult.That was nine years ago, when she was 41 years old. Ericka had gone to her local eye doctor because she was losing vision. Somemes for only minutes, but at other mes for hours, a grey curtain would descend over the vision in her le eye. eye to eye newseye to eye newsLIVING WITH GLAUCOMAPaent Advocate and MyEyes Glaucoma Paent AmbassadorEricka Shepardeye to eye newseye to eye newseye to eye newseye to eye news

The Glaucoma Foundation | Page FiveDoctor, I Have a Question.What are the steps for a new (glaucoma) drug to go from the lab to paents?Gustavo De Moraes, MD, PhD, MPHAssociate Professor of Clinical Ophthalmology at Columbia University Irving Medical Center, Chief Medical Ocer at Ora Clinical, Inc.The most important thing to remember is that the course of clinical trials from lab to paent is extraordinarily rigorous, with safety and ecacy the two key consideraons throughout. Clinical research studies usually start with some basic science research in the lab, for example, invesgang a new glaucoma drug that could benet paents in the future. But before tesng the new drug on humans, the lab has to test the drug on animals (mice, guinea pigs, monkeys) for toxicity and ecacy. The FDA requires a series of preclinical studies done in accordance with good laboratory pracces. The tests have to be conducted in qualied labs, with precise methodology to see if there is any eecveness 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 creang new problems. The tests on animals also help determine the inial dose to test on human paents – 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 eects, and to test the maximum dosage that is tolerated. Once the drug’s safety is conrmed, Phase Two begins.During Phase Two -- a larger study, with dozens to hundreds of glaucoma paents taking part -- we are sll primarily interested in safety, including short and long-term side eects, but we can also start to study some ecacy endpoints – for example, IOP lowering, progression on OCT or visual eld 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 exisng medicaons for the same condion. Somemes known as pivotal studies, these large, mul-center studies can involve up to eye to eye newseye to eye newsconnued on page 6eye to eye newseye to eye newseye to eye newseye to eye news

The Glaucoma Foundation | Page SixCLINICAL TRIALS connued from page 5thousands of parcipants and last several years. These are so-called randomized, masked, clinical trials with some parcipants receiving the new medicaon and others receiving placebo or an exisng medicaon. Masking of paents and doctors is oen required to make sure nobody knows who is taking the invesgaonal drug or placebo. Rare and long-term side eects are more likely to show up during this phase. These studies, usually two independent studies, have to meet safety and ecacy 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-markeng studies provide addional informaon about the risks, benets and best use of the drug in a much larger populaon in the real world aer the drug has completed the other stages and has been authorized for commercializaon.Your donaons maer.Help to fund sight-saving research by joining us in August for the 4th annual Art Challenge to Celebrate Vision.Find out how, here:Thank you for giving.eye to eye newseye to eye newseye to eye newseye to eye news

The Glaucoma Foundation | Page Seven eye to eye newseye to eye newseye to eye newsPreservative-Free Glaucoma Eye DropsIt is esmated that roughly half of all paents on long-term glaucoma therapy suer from ocular surface disease (OSD), including dry eye syndrome. OSD can cause redness, tearing, irritaon, burning, foreign body sensaon, light sensivity and somemes blurred vision. One of the issues is that all mul-dose ophthalmic medicaons are required to have a preservave to maintain the anmicrobial environment in the bole. While OSD can be caused by acve ingredients in in a parcular glaucoma eye drop, it’s widely known that the preservave benzalkonium chloride (BAK) used in many drops can aect the ocular surface. In fact, the prolonged use of eye drops preserved with BAK is a strong risk factor for ocular surface disease in paents with glaucoma. And paents who must use two or more medicaons have worse OSD.There is an acknowledged need for the pharmaceucal industry to connue addressing BAK-free opons, minimizing OSD and improving paents’ quality of life as well as adherence to their medicaon regimen. These products fall into two categories: BAK-free preserved medicines (using alternave preservaves to BAK) and preservave-free medicines.There are currently three preservave-free medicaons available in the United States. Two other drugs use alternave preservaves. The three available topical glaucoma medicaons completely free of preservaves are: Zioptan (tauprost ophthalmic soluon 0.0015%, Cosopt PF (dorzolamide-molol ophthalmic soluon 2%/0.5%, and Timopc in Ocudose (molol maleate ophthalmic soluon 0.25% and 0.5%. The FDA has just approved the rst formulaon of latanoprost, Thea’s lyuzeh. Generic versions of preservave-free Zioptan, Cosopt and preservave-free Timopc.are also available. Each of these products is supplied as a sterile soluon in single-use containers. Once the vial is opened, the paent should apply the medicaon to the eye, and then immediately should discard the container and its remaining contents. Paents with poor dexterity may have diculty handling the small containers. And the risk of contaminaon is a concern if a paent saves excess soluon for later. The two BAK-free products that use other preservaves and aim to reduce toxicity to the ocular surface are Travatan Z (travoprost ophthalmic soluon 0.004%, preserved with SofZia, and Alphagan P (brimonidine tartrate ophthalmic soluon, 0.1% or 0.15%, preserved with Purite. eye to eye newseye to eye news

PRESIDENT’S MESSAGEconnued from page 1Many thanks to the Think Tank Commiee, our sponsors Théa Pharma, Avellino, Santen, iCare, Ora Clinical, Qlaris Bio, Sight Sciences, Topcon, Triad Foundaon, Glaukos, Opthalmology 360, and Research to Prevent Blindness, and to our individual supporters, and the twenty-ve 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 Innovaon in Glaucoma. Established in 2008 by The Glaucoma Foundaon and named in honor of its rst recipient, the founder and medical director of TGF, the Ritch Award recognizes the contribuons of individuals who have played a signicant and unique role in promong the medicine and science of glaucoma. Dr. Pasquale is a disnguished member of the Foundaon’s Board of Directors and co-chair of the Scienc 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 experse and his dedicaon to research and paent care. On June 16, I joined Dr. Aakri 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 eects of glaucoma eye drops. They discussed the need for more preservave-free drops to lessen ocular surface disease, a subject of vital importance to all glaucoma paents. To that end, TGF is one of four founding members of the Preservave Freedom Coalion to Advocate for Preservave-free Eyecare, recently launched by Théa Pharma. In this issue, you can learn about the mechanisms of clinical trials, how a paent is living with a rare form of glaucoma and serving as a paent advocate, and how you can further glaucoma research by joining “Visions for Vision” this summer. With your ongoing support, we connue to advocate and work in partnership with others on important issues that can improve the lives of glaucoma paents. With gratude, Elena Sturman We hope you nd this newsleer issue of interest and informave. If you’d like to suggest an arcle for the future, please let us know. We value your readership and your support for all that we do.info@glaucomafoundaon.orgThe Glaucoma Foundation | Page Eighteye to eye newseye to eye news