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Eyenovia, Inc., a commercial-stage ophthalmic company, has entered into a collaboration agreement with Senju Pharmaceutical Co., Ltd. With the two companies joining forces, they intend to work to develop Senju’s corneal epithelial wound healing candidate, SJP-0035, for use alongside Eyenovia’s Optejet® dispensing technology, aiming to use both products as a potential treatment for chronic dry eye disease.

“We are very pleased to further leverage our proprietary Optejet platform through this collaboration agreement with Senju, a global leader in eye care that has been part of the Eyenovia family since our inception,” Michael Rowe, chief executive officer of Eyenovia, said.

The companies plan to meet with the US Food and Drug Administration (FDA) to present a clinical development proposal, as stated in the terms of the agreement. If successful, the FDA could support a New Drug Application (NDA) filing for the treatment. The treatment could also have financial benefits as well, as the current cost of the treatment for chronic eye disease is over $3 billion in the US and $5 billion globally.

In prior Phase 1 and Phase 2 studies, SJP-0035 as an eye drop has been shown to be well received at multiple doses tested in over 250 subjects. A planned Phase 2b trial would test SJP-0035 administered in the Optejet dispenser.

Mitsuyoshi Isaka, a corporate executive officer of Senju, said, “SJP-0035 has a unique mechanism of action that has the potential to offer dry eye patients additional relief when compared to existing treatment options alone, while also demonstrating a very favorable tolerability profile. When integrated with a novel dosing platform such as the Optejet, we believe we can create a more efficacious and highly differentiated treatment that could quickly become the new standard of care for this very prevalent ophthalmic condition. We look forward to a long and mutually successful partnership.”

A meeting with the FDA is expected later this year, followed by the execution of a definitive agreement relating to the further development of SJP-0035 and the anticipated completion of a Phase 2b study next year. With approval, the companies could expand upon their collaboration agreement to bring the product into two Phase 3 studies by 2026.

Eyenovia and Senju Pharmaceutical Co., Ltd. Sign Collaboration Agreement for Potential New Treatment for Chronic Eye Disease. News release. Yahoo! Finance. Accessed July 23, 2024. 

Eyenovia and Senju Pharmaceutical Co., Ltd. Sign Collaboration Agreement for Potential New Treatment for Chronic Dry Eye Disease (yahoo.com)

The collaboration agreement will allow the two companies to find a potential new treatment for chronic dry eye disease.

Eyenovia, Inc. and Senju Pharmaceutical Co., Ltd. sign new collaboration agreement

Cataract surgery has undergone transformational advancements in recent years, and one notable innovation is the adoption of dropless cataract surgery. This technique aims to eliminate the need for postoperative topical eye drops, streamlining the recovery process and potentially improving patient adherence. This article reviews the principles behind dropless cataract surgery, explores its advantages in the postoperative period, and discusses its implications for patient satisfaction and overall surgical outcomes.

Cataract surgery, a routinely performed procedure globally, has traditionally involved the use of postoperative topical eye drops to prevent infection and manage inflammation. Dropless cataract surgery represents a departure from this conventional approach by using intracameral drug delivery during surgery to provide extended postoperative prophylaxis.1

The traditional regime for treating a patient who undergoes cataract surgery begins with the preoperative routine of prescribing
3 essential topical medications that the patient begins to take 1 day before surgery. These medications include an antibiotic such as a fourth-generation quinolone, a nonsteroid anti-inflammatory, and a steroid to be taken 4 times a day, starting the day before surgery and continuing for 1 week. At the end of the first week, the antibiotic drop is discontinued as long as the patient is improving. The nonsteroid and steroid anti-inflammatory topical medications are continued twice a day until 1 month post operation, at which point the medications are fully discontinued.

Dropless cataract surgery typically involves the injection of medications consisting of an antibiotic, corticosteroid, and nonsteroid into the eye’s anterior chamber during the surgical procedure.

This eliminates the need for the patient to self-administer topical drops postoperatively, addressing issues related to adherence, convenience, and potential complications associated with eye drop usage, such as poor dexterity in elderly patients or contamination of the bottle tip.

 The principle is that intraocular medications maintain bioavailability for at least 28 days, eliminating the need for postoperative topical medications.

Enhanced patient adherence is one of the most important benefits of the dropless regimen. Eliminating the reliance on postoperative eye drops simplifies the patient’s postoperative care regimen. Improved adherence may lead to better outcomes, reducing the risk of complications associated with missed or improperly administered eye drops.

Reduced medication burden is a benefit that serves both patients and physicians. Patients are spared the inconvenience of multiple eye drops, potentially decreasing the likelihood of medication-related adverse effects and simplifying the postoperative recovery.

Minimized complications are well documented. Dropless cataract surgery reduces the risk of contamination associated with topical eye drops, lowering the potential for infection and inflammation. The intracameral route of drug administration may enhance the efficacy of antibiotics and corticosteroids, minimizing the risk of postoperative complications.

Eliminating the need to purchase postoperative eye drops improves cost efficiency as well.

 Dropless cataract surgery may contribute to cost savings for patients and health care systems. Often, patient coverage for medication is incomplete and leaves the patient without the required medication. Medications can sometimes be out of stock or unavailable for dispensing until after the date of surgery. Patients often wait for medications for several days, or they may have to wait for prior authorization approval before the medications can be dispensed.

Clinical evidence is mounting that documents the safety of the dropless regimen. Data demonstrate that a postoperative topical antibiotic does not reduce the risk of endophthalmitis. Patient satisfaction is also a driving force for the movement. Several studies have investigated the safety and efficacy of dropless cataract surgery, with early findings suggesting comparable or improved outcomes compared with traditional postoperative care regimens. Furthermore, patient satisfaction surveys have highlighted the convenience and reduced postoperative burden associated with this approach.

Although dropless cataract surgery offers compelling advantages, challenges such as the availability of compounded medications, potential allergic reactions, and variations in surgeon preferences should be considered. Further research is needed to establish standardized protocols and assess long-term outcomes.

The evolution of dropless cataract surgery warrants exploration into its long-term safety, comparative effectiveness, and broader adoption within the ophthalmic community. Additionally, advancements in drug-delivery technologies may further refine and expand the applications of this innovative approach.

My 3-step dropless cataract surgery technique

My dropless cataract surgery technique begins with infusing 4 cc of phenylephrine and ketorolac intraocular solution 1%/0.3% (Omidria; Rayner Surgical Inc) into the balanced salt solution irrigating bag before the start of the case. After I have removed the cataract and inserted the IOL, I then inject 2 cc of compounded mix of dexamethasone 1 mg/mL, moxifloxacin 0.5 mg/mL, and ketorolac 0.4 mg/mL (Dex-Moxi-Ketor PF; ImprimisRx) intracamerally. At the end of the case, I insert a dexamethasone ophthalmic insert 0.4 mg (Dextenza; Ocular Therapeutix, Inc) into the canaliculi of the respective lower eyelid.

Phenylephrine and ketorolac ophthalmic solution 1%/0.3% has been a true game changer at the forefront of the dropless regimen. The FDA has approved the agent for intraoperative dilation and postoperative pain control, and it combines 2 active ingredients: phenylephrine and ketorolac.

 These components serve different purposes during the surgery:

This is a sympathomimetic agent that acts as a vasoconstrictor. It helps to dilate the pupil (mydriasis) by constricting the blood vessels in the eye. This is particularly useful during cataract surgery to give the surgeon a better view of the lens and other structures inside the eye.

Ketorolac is a nonsteroidal anti-inflammatory drug. It works by reducing inflammation and pain. In the context of cataract surgery, ketorolac helps manage intraoperative miosis (pupil constriction) and postoperative inflammation.

Phenylephrine and ketorolac ophthalmic solution 1%/0.3% is administered as an intracameral injection into the eye’s anterior chamber during surgery. Its mydriatic and anti-inflammatory effects combined in a single formulation simplify the regimen for surgeons and patients, as it reduces the need for separate medications to achieve the same effects.

The use of phenylephrine and ketorolac ophthalmic solution 1%/0.3% is intended to enhance surgical visualization, maintain pupil dilation, and reduce inflammation and pain during and after cataract surgery. The goal is to improve surgical outcomes and enhance the overall patient experience during the perioperative period. It is important to note that the surgeon determines the use of specific medications, including phenylephrine and ketorolac ophthalmic solution 1%/0.3%, based on the patient’s needs and medical history. In my clinical experience, I have reduced the use of intracameral lidocaine-PF. Patients are more comfortable throughout the cataract procedure, and I have fewer complaints of intraoperative pain. Postoperatively, the eyes are quiet with minimal chamber cell and flare. Conjunctivae are white and quiet. Patients who have received phenylephrine and ketorolac ophthalmic solution 1%/0.3% have fewer complaints of foreign body sensation and glare.

Dexamethasone-moxifloxacin-ketorolac 1.0/0.5/0.4 mg/mL is an intraocular, preservative-free solution injected intracamerally at the end of the case, usually after insertion of the IOL. The indications are to reduce postoperative inflammation, reduce inflammation of the eye’s anterior segment, prevent bacterial endophthalmitis, and reduce postoperative pain. Possible adverse effects include delayed wound healing, increased IOP, eye irritation, and corneal edema. This compound effectively eliminates the need to use topical antibiotics, steroids, and nonsteroidal drugs. In my experience, from postoperative day 1, most corneas appear clear, and the anterior chambers are deep and quiet. Most importantly, patients have reduced redness and much fewer complaints of eye discomfort. The topical equivalent antibiotic, such as ciprofloxacin dosage 4 times daily, can be effectively eliminated. Literature shows that postoperative topical antibiotics are less effective in eliminating endophthalmitis than intracameral moxifloxacin, which garnered an endophthalmitis incidence rate of less than 1%.

The third step in my dropless routine includes a dexamethasone ophthalmic insert. A health care professional places a small, resorbable insert into the lower punctum of the eye. The insert gradually dissolves over up to 30 days, releasing a controlled amount of dexamethasone into the eye. The active ingredient, dexamethasone, is a corticosteroid with anti-inflammatory and immunosuppressant properties. The sustained release of dexamethasone helps manage inflammation and pain associated with ocular surgery, such as cataract surgery.

 By offering sustained drug release, the insert may contribute to improved patient adherence and convenience during the recovery period after ophthalmic surgery.

It is important to note that the treating ophthalmologist determines the use of a dexamethasone insert based on individual patient needs and the specific requirements of the surgical procedure. As with any medication, patients should follow their physician’s instructions regarding its use and report any concerns or adverse effects promptly. IOP should be monitored as a possible adverse effect.

 denotes the fact that patients are not compelled to use drops as they would have traditionally had to. It represents a significant advancement in cataract surgical techniques, offering tangible postoperative advantages for patients. By addressing adherence issues, minimizing complications, and streamlining the recovery process, dropless cataract surgery can enhance patient satisfaction and improve overall outcomes in ophthalmic surgery. The combination of an intracameral medication such as phenylephrine and ketorolac and dexamethasone-moxifloxacin-ketorolac combined with a dexamethasone implant can result in improved adherence and reduced cost. Further research and collaboration within the medical community will be crucial for optimizing protocols, ensuring safety, and establishing this innovative technique as a standard of care in cataract surgery.

Wotipka EK, Wright AJ, Fan JZ, et al. Postoperative complications of true dropless cataract surgery versus standard topical drops. 

. 2023;15(2):e144-e153. doi:10.1055/
s-0043-1771043

Donnenfeld ED, Hovanesian JA, Malik AG, Wong A. A randomized, prospective, observer-masked study comparing dropless treatment regimen using intracanalicular dexamethasone insert, intracameral ketorolac, and intracameral moxifloxacin versus conventional topical therapy to control postoperative pain and inflammation in cataract surgery. 

. 2023;17:2349-2356. doi:10.2147/OPTH.S422502

Pandey SK, Sharma V. Transzonular drug delivery during cataract surgery: is dropless cataract surgery really beneficial? 

. 2018;66(9):1377-1379. doi:10.4103/ijo.IJO_830_18

Shorstein NH, Myers WG. Drop-free approaches for cataract surgery. 

. 2020;31(1):67-73. doi:10.1097/ICU.0000000000000625

Anderson J, Young S, Cockerham G, Chomsky A, Parr NJ. 

Evidence Brief: Intracameral Moxifloxacin for Prevention of Endophthalmitis After Cataract Surgery

. Department of Veterans Affairs (US); 2022.

Fram N, Alsetri H, Shiler O, Paterno PJ, Cabang J. Retrospective study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation after cataract and corneal surgery. 

. 2022;16:4065-4074. doi:10.2147/OPTH.S386702

Removing drops improves adherence and comfort for most patients.

Dropless cataract surgery: Revolutionizing postoperative care for enhanced patient outcomes

Genentech this week announced the FDA has approved faricimab-svoa (Vabysmo) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).

The company, a member of the Roche group, noted in its news release that together, these 3 conditions affect close to 3 million people in the U.S. The faricimab-svoa prefilled syringe will become available to U.S. retina specialists and their patients in the coming months. The single-dose prefilled syringe offers the same medication as existing Vabysmo vials, and offers physicians an alternative, ready-to-use option. It will continue to be available in a 6.0 mg vial.

Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of Global Product Development, noted in the news release that the company was pleased the FDA gave its approval to the Vabysmo PFS for people living with wet AMD, DME and RVO, which are some of the leading causes of vision loss.

“While many retina specialists are already using Vabysmo as a first-line treatment, this new offering should make it even simpler to administer, thereby enhancing the treatment experience for both physicians and patients,” Garraway said in the statement.

According to the company, Vabysmo (faricimab) targets and inhibits two signaling pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). While research is underway to better understand the role of the Ang-2 pathway in retinal disease, Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. By blocking pathways involving Ang-2 and VEGF-A, faricimab is designed to stabilize blood vessels.

The company noted in its news release Vabysmo is the first and only bispecific antibody approved for the eye and has demonstrated rapid and robust vision improvements and retinal drying in wet AMD, DME and RVO. Retinal drying is an important clinical measure, as swelling from excess fluid in the back of the eye is associated with distorted and blurred vision.

To date, Vabysmo is approved in more than 95 countries for wet AMD and DME, and in several countries, including the U.S. and Japan, for RVO. Review by other health authorities across the globe is ongoing. More than four million doses of Vabysmo have been distributed globally since its initial U.S. approval in 2022.

1. Genentech: Press Releases | Thursday, Jul 4, 2024. www.gene.com. Accessed July 5, 2024. https://www.gene.com/media/press-releases/15030/2024-07-04/fda-approves-genentechs-vabysmo-prefille

According to Genentech, faricimab-svoa is the first and only syringe that is prefilled with an FDA-approved bispecific antibody to treat wet AMD, DME and RVO.

FDA approves faricimab-svoa prefilled syringe for treatment of wet AMD, DME and RVO

This quiz accompanies THIS article from our December issue

c. One-third eye width, canthus to canthus

d. One-third eye fissure opening vertically

Quiz: Know the ocular effects of eyelash growth serums

Despite the growing prevalence of myopia, there is still a long way to go before myopia management becomes a standard of care among eye care professionals (ECPs) in Latin America.

Results from 2 surveys conducted 4 years apart, in 2019 and 2023, have shown that although more than half of Latin American ECPs integrate myopia management into their practices, a substantial portion are not actively engaging in such interventions.

Those individuals surveyed cited several challenges, including limited knowledge and poor availability of specialized lenses and other related products.

Adding to the challenge, each region in Latin America has its own specific needs, products, and information available when it comes to vision care. With more than 30 countries in Latin America, finding a way to standardize myopia management knowledge and care is essential. We need better education, support from the optometric industry, and more research in the region.

As an optometrist working in Mexico City, Mexico, I’ve focused my practice on myopia management for children, adding new treatments and technology to better meet patients’ vision challenges and offer them high-quality service. Years ago, myopia management was seen as a new discipline for ECPs, demanding a new way to see each patient in our office. I now believe myopia management is necessary for each child whom we see in our practice to protect their vision, both now and in the future.

Taking myopia management from theory to practice

In February, I joined other ECPs as the host for the World Council of Optometry (WCO)’s first Latin America–based virtual event, Myopia Management: From Theory to Practice, held in partnership with CooperVision. Over 4 days, more than 3000 ECPs representing 25 countries across the region attended four 90-minute sessions virtually, all in Spanish, aimed at providing advice and practical actions to get started with myopia management and make it a standard of care. Some of the sessions were also aimed at reaching optometrists who are more experienced in their myopia management journey and interested in delving deeper into practical strategies.

As hosts, we each had the opportunity to select topics specific to the different needs in each of our countries. We received over 100 questions per session. One question we heard often was, “I have very young patients with high myopia. What can I do for these children?” This question confirms the need to implement myopia management in our countries and in our practices earlier. We can’t wait to start myopia management when the patient needs a prescription as high as –10 or –12 D. It underscores the situation in our countries and emphasizes the need to prioritize primary care for myopia.

There are 3 things I hope attendees took away from the virtual event. First, follow the science. As ECPs, we have an obligation to make recommendations to patients based on the growing body of evidence on myopia. There are practical, evidence-based tools you can implement into your practice.

Second, and what is most important to me, is that ECPs initiate myopia management within their practice now if they haven’t already, conducting early tests for children and carefully selecting advice and treatments tailored to each child’s needs. By starting myopia management early, ECPs can monitor the progress of their patients over time, seize opportunities to prescribe new alternatives, and assess the effectiveness of treatments for individual patients.

Third, the work to adopt myopia management as a standard of care must continue. As a follow-up to the virtual event, the other hosts and I are considering what new events or workshops we can offer in our home countries to continue the conversation.

For those who missed the virtual event, the 

 sessions are available online with English captions.

Management of myopia in Latin America: A preliminary analysis. Group Manejo de la Miopía LATAM. 2019. Accessed April 17, 2024.

Survey on myopia management in Latin America. Group Manejo de la Miopía LATAM. 2023. Accessed April 17, 2024.

Ricardo Pintor, OD, FIACLE, gives an overview of the World Council of Optometry’s first Latin America–based virtual event and what challenges Latin America faces in terms of myopia.

Conference

Furthering the adoption of myopia management in Latin America

Drs Erin Draper and Chris Cuk highlight the importance of optometrists catching neurodegenerative diseases

AOA 2024: Uncovering the ocular connection in neurodegenerative diseases

With family history and lifestyle risk playing a role in neurodegenerative disease development, spotting cognitive changes early can make a significant impact on patient quality of life. Erin Draper, OD, FAAO, and Christopher Kuc, OD, FAAO, outline their talk from the AOA Optometry's Meeting that highlighted the important role eye care providers can play in catching biomarkers early through routine eye exams.

 This transcript has been lightly edited for clarity.

Hi, I'm Erin Draper. I'm associate professor at the Pennsylvania College of Optometry (PCO).

I'm Chris Kuc, I'm in private practice at Medical Optometry America in Newtown Square, Pennsylvania. Our talk stems around neurodegenerative disease, and sort of bringing that topic to optometric practice and a lot of the connections that exist between the eye and the brain. We're kind of an odd pair because I'm in private practice and Dr. Draper's in academia at PCO in the neuro department. So we thought: Well, if we give a talk that focused on practical approach and applications to these patients, you know, it's a topic that's come to prominence in the media, in the news, and our patients want to know about it. And from a practical perspective, I like to educate my patients, especially lifestyle and things we can do to avoid these kind of problems later in life. And Dr. Draper focuses more of her practice specifically on neuro, so I thought, "Boy, this could be a good topic."

Right, so we were trying to focus on looking at the anatomy connections between the eye and the brain. And another thing being that we as optometrist now have more tools in our toolkit that really look at the brain, like our OCT, and other ancillary testing visual fields or whatnot. So we're actually measuring and looking at brain and when we talk about neurodegenerative disease, it's about atrophy in the brain. And we're seeing this very similar atrophy in the eye. So what we then [have been] discovering over the past decade or so is that the eye is going to be a really great place for looking for biomarkers for really detecting early neurodegenerative disease, because our goal is to detect it early, get the treatments in early, improve the quality of life of these patients. And we have a large role to play in that. And Chris really talked a lot about [how he] can talk to his patients and really educates them on what they can do to help prevent [neurodegenerative disease], some of the lifestyle modifications and things like that. So I know in your practice, you talked a lot about a few things and I think you share some of those things that you find important to educate those patients on.

Sure, yeah. You know, a lot of these patients may know they have risk, they know they have family history. That said, lifestyle's a talk that's very easy for optometrists. We're used to giving it for dry eye, diabetes, macular degeneration. So the the topics kind of come naturally to us, as it relates to neurodegenerative problems. Similar things; our health system in America, 18% of the GDP is spent on health care. So if you have one of the highest costs and unhealthiest patients, so our western lifestyle is the problem. So inflammation is what we're trying to counter. But the lifestyle changes, things like exercise, supplements like omega-3s that are looked at now — we're comfortable talking about those for dry eye — they also apply to all the other chronic diseases. But again, controlling underlying disease, exercise, diet. Specifically, they've looked at the Mediterranean style diet, they've looked at a think called the MIND diet, which applies those Mediterranean style principles with hypertensive style diet, combine those two, and that's worked really well for patients with Alzheimer's, dementia. So having these discussions for patients that may be healthy or have a family history is important to have. We can intervene early and get our patients thinking about changing their health by exercise, diet, and lifestyle changes, they may have less complications down the road. So optometry is predominantly a profession that sees a lot of healthy people. But we do have patients that actually have the disease. So you know, once they're diagnosed, and we know they have Alzheimer's or one of the neurodegenerative diseases, we have to be able to offer practical approaches to help these patients in predominantly vision and addressing their visual concerns. But it could be low vision, it could be filters, could be text-to-speech devices. There's a lot of things we can offer our patients that really improve the quality of life for these patients.

So patients that we bring this up with are ones that maybe have a family history, or maybe we're seeing some abnormalities on the eye exam that aren't matching with other things. I say, "Could this be a neurodegenerative disease factor involved in here?" As we said, neurodegenerative disease is neurons atrophy, glaucoma, and many other eye disease are like that. But if I don't think it's truly that and I think this could be neurodegenerative disease, I have this conversation with them that you know, maybe I'll say, "Any issues with your memory? Any other motor issues? Any other neurological concerns that you have?" And if they do, I'm thinking, maybe they should talk to a neurologist. Maybe there's some other testing other than the eye exam that we should be exploring that could explain the cause of the issues you are having. So that's kind of where I kind of start the conversation with my patients, just based on their history, and also based on do I see any abnormalities of the exam that aren't matching up [unintelligable] in terms of patients.

Oh, I think people for the most part are pretty open to the idea. Whether they apply those principles to their life, that's a whole other story. But the whole topic itself is really, really interesting and one thing that we haven't really mentioned yet is technology that we have in our offices now is what they're studying. So, you know, OCT, ERG, VEP, SAKAB, different tracking devices that are out there, visual field tests. These are things that we have at our disposal, we're comfortable using it for glaucoma and monitoring those images for diabetics and macular degeneration. That's part of our regular everyday practice now, but how do we apply those tests to patients that actually have neurodegenerative disease? And can we detect abnormalities that we can directly connect to those diseases and the fact of the matter is we can now, but how can we get those patients earlier? And that's where the interest comes. So the health system in general is looking for ways to identify these patients before they start to have the cognitive decline. And the puzzle is not all put together just yet. But if we're on top of it, and we're part of that picture, I think optometry really can play a key role in being able to deliver great care to patients.

The key takeaways from our talk, our purpose of giving it, is really just making optometrists aware of the role that they play with patients that either have neurodegenerative disease or are at risk for developing neurodegenerative disease, and realizing that we're part of the health care team to get them that early intervention and also being part of seeing where we're going in the future. So we have these tools in our office that are going to be really great biomarkers for the future in working with neurologists. Being parts of clinical trials even, and that we're being part of the team that's ... going to treat these patients by getting them diagnosed early and being a part of the team. So I think for me, that's a big takeaway that we can be aware of. In addition, as you said, making sure that the patients have the education of what they can do between ... what changes can they make in their life? What changes can they make in their lifestyle? Increasing their exercise, changing their diet, and the great health benefit that will essentially come from that. Particularly if they have a family history of dementia or other neurodegenerative disease.

Drs Erin Draper and Christopher Kuc reiterate the important role optometrists play in identifying biomarkers for neurodegenerative diseases in patients.

Andy Pawson

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