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A review of the phase 4 PALADIN data show that steroid-eluting implants lead to good vision, safe outcomes, and reduced burden in patients with DME.

Why wait? The data show administering steroids to DME patients with good vision leads to long-term success 

Eyestem Research Private Ltd hopes to shift the paradigm of ophthalmology in India with the completion of the first set of 3 patient injections for its RPE suspension therapy for dry 

According to the company, AMD is a leading cause of blindness in individuals more than 60 years of age, impacting an estimated 196 million people globally.

The company’s Eyecyte-RPE is a patented suspension of retinal pigment epithelium cells aimed at combating geographic atrophy arising from dry AMD. This treatment, according to the company, has the potential to replace damaged retinal cells and treat this disease.

The first human trial, led by Rajani Battu, PhD, chief medical officer of Eyestem, will include 36 patients across 3 ophthalmology centers in India.

The first phase will treat 9 patients with very low vision and will concentrate on safety while the second phase will treat 27 patients with intermediate vision loss in order to determine efficacy

“Completing the first 3 patient injections of Eyecyte-RPE represents a critical milestone for our quest to find a cure for Dry AMD,” Battu said in the news release. “With the support of exceptionally skilled surgeons at our trial sites, we are optimistic that we can bridge the gap between lab application and real-world hope.

Rajpal Vohra, MD, of AIIMS, Delhi; Raja Narayanan, MD, of LV Prasad Eye Institute, Hyderabad; Rushikesh Naigonkar, MD, of Ganpati Netralaya, Jalna; and Rohan Chawla, also of AIIMS, Delhi, are all retinal surgeons involved in the study.

“Dry AMD and associated vision loss present a massive burden on patients in India and abroad” they said in a joint statement included in the news release. “We are excited about supporting this research which has the potential of helping such patients. It is a matter of great pride that such an innovation is coming out of India for the world and hope that this is the start of a new age of medicine where India leads the way.”

Ramesh Byrapaneni, MD, who is the managing director of Endiya Partners, expressed his support for the research.

As a clinician and an early investor in Eyestem, I am thrilled to see Eyestem taking their first product developed from induced pluripotent stem cells into clinical development,” Byrapaneni said.

Since 2017, Eyestem has developed a scalable cell therapy platform for incurable diseases and is moving its flagship product for dry AMD into human trials.

According to the company, the pre-clinical safety and efficacy studies of its product have yielded positive results in 3 internationally recognized labs in India, Singapore, and the United States. The therapy showed beneficial effects on the degenerating retina in animal models without any major safety concerns, indicating its potential substantial therapeutic value for dry AMD.

According to the company, the pre-clinical safety and efficacy studies of its product have yielded positive results in 3 internationally recognized labs in India, Singapore and the United States.

clinical

Canonical

Eyestem completes first round of patient injections for its dry AMD treatment

Diagnos Inc. has announced that its quality management system is fully compliant with ISO 13485 standard and applicable regulatory requirements for medical devices.

As part of the requirements for the commercialization of the company’s flagship product CARA, DIAGNOS must undergo thorough statutory quality compliance audits under the Medical Device Single Audit Program (MDSAP).

Yves-Stephane Couture, Chief Operating Officer of DIAGNOS, noted in the company’s press release

 that this certification is approved by multiple governments, including Canada and the US. He said, “I would like to take this opportunity to thank our employees for their hard work in this important process. Our clients expect our healthcare solutions to perform in compliance with the highest quality standards and DIAGNOS is able to meet their expectations. Without this certification we are not allowed to sell our solutions worldwide. This new certification also covers all new AI based regulatory requirements that have been approved by multiple governments including: Canada, USA and European countries.”

Similarly, André Larente, President of DIAGNOS, marked the milestone for the company and shared the future expectations of DIAGNOS, saying, “This huge achievement from our team comes at a time where Artificial Intelligence is growing and we want to be the leader in our field. DIAGNOS has reached an inflection point in its sales growth going from a one test company for diabetics to a company providing a suite of tests thereby accelerating profitability and patient satisfaction. A report from Precedence Research said that the global artificial intelligence (AI) in the healthcare Market size, which was USD 19.27 billion in 2023 is estimated at 26.69 billion in 2024 and is anticipated to reach around USD 613.81 billion by 2034, expanding at a CAGR of 36.83% from 2024 to 2034.”

, DIAGNOS is currently in the process of obtaining regulatory licenses in Canada (Health Canada) and in the USA (US-FDA) for 4 additional modules to assist health care professionals in identifying generally abnormal through optical coherence tomography retinal images and in the grading of fundus images to detect signs of retinopathy for general public adult, age-related macular degeneration, diabetic retinopathy and hypertensive retinopathy.

1. DIAGNOS Successfully Completes ISO 13485 / MDSAP Audit and receives its certification to move forward with FDA and Health Canada. DIAGNOS Inc. August 20, 2024. Accessed August 30, 2024. https://www.globenewswire.com/news-release/2024/08/20/2932928/0/en/DIAGNOS-Successfully-Completes-ISO-13485-MDSAP-Audit-and-receives-its-certification-to-move-forward-with-FDA-and-Health-Canada.html

This certification covers AI based regulatory requirements for the company's platform for AI imaging and diagnostic tools.

Diagnos Inc. meets compliance requirements for ISO 13485 standard

In this podcast, John Kitchens, MD, is joined by Peter Kaiser, MD. They discuss higher molar dose and share pearls and their clinical best practices.

What are the challenges when treating patients with higher molar doses? How can clinicians help patients transition to a higher dose? Listen and find out today.

Don't miss the full podcast – or the key takeaways below.

Increasing aflibercept dose for longer drug duration in eyes.

A deep dive into how increasing aflibercept dose improves drug durability in the eye

Modeling suggests slower ocular clearance with higher dose of aflibercept

Drug half-life and dosing for anti-VEGF treatments in ophthalmology.

How the half-life of aflibercept is determined in the eye using PK sampling and modeling

Highlights of studies include dose regimen modifications and durability of drug in second year

Accelerating aflibercept dosing intervals for wet AMD patients.

Designing clinical studies translating the "treat and extend" approach to the real world

Potential benefits of longer-acting eye medication, including increased efficiency and reduced burden on healthcare providers

Potential biomarkers that indicate a need for frequent VEGF injections in wet AMD patients

Emphasising the importance of early treatment with the strongest medication for type three lesions to prevent permanent vision loss

John Kitchens, MD, and Peter Kaiser, MD, discuss drug duration, accelerating dosing intervals, and other pearls for aflibercept dosing in wet AMD.

Implementing Higher Molar Dose in Your Clinical Practice

Fasika Woreta, MD, discusses the Roman Barnes Distinguished Lecture ahead of the National Medical Association meeting

Ahead of this year's National Medical Association (NMA) Annual Convention and Scientific Assembly, the Eye Care Network caught up with Fasika Woreta, MD, who is the outgoing chair of the NMA Ophthalmology section. Dr. Woreta is the Eugene de Juan, M.D. Professor of Ophthalmic Education at Wilmer Eye Institute’s Baltimore and Columbia locations. She currently serves as the director of the Eye Trauma Center and the director of the Ophthalmology Residency Program at the Wilmer Eye Institute in Baltimore, Maryland.

Dr. Woreta spoke to us about giving the Roman-Barnes Distinguished Lecture at this year's convention, what makes the scientific meeting so special, and why clinicians are in the golden age of cornea care.

Editor's note: The below transcript has been lightly edited for clarity.

 Hi, my name is Hattie Hayes and I'm the editor of Ophthalmology Times Europe. August kicks off with the National Medical Association holding its annual convention and scientific meeting in New York City. Joining me today, I have Dr. Fasika Woreta. We're going to talk about her presence at the meeting and what we can look forward to there. Thank you so much for joining me today.

 Thank you so much for having me, Hattie. I'm excited to talk about the NMA meeting that's starting this Saturday.

 I know that you are giving the Roman Barnes Distinguished Lecture at this meeting. Congratulations. Could you tell me a little bit about the lecture and what attendees can expect?

 It's my distinct honor to give the Roman Barnes Lecture, which is traditionally reserved for the outgoing Chair of the National Medical Association, which is the largest association of Black physicians. In particular, it's an honor to give it in honor of Dr. Roman as well as Dr. Barnes. Dr. Roman, was the first physician of African ancestry from North America to do have training in both ophthalmology and otolaryngology. Amazingly, his parents were fugitive slaves, and he was the fifth president of the National Medical Association. Dr. Barnes was an otolaryngologist, and he was the first president of the National Medical Association, and the Society for the Promotion of Negro Specialists in Medicine. So it's, again, a great honor and symbolic to be giving this lecture in their honor. And my lecture will be focusing on the presence of Black ophthalmologists in academic medicine. So currently, only about 3% of our workforce is composed of Black ophthalmologists. And as we go up the ranks in terms of professor and chair, that [proportion] gets even smaller. So, again, in honor of these two physicians who are pioneers in academic medicine, and, again, the first and fifth chair of the NMA, respectively, I'm very grateful for the opportunity to honor them.

 Speaking a little bit about your work, I know that you are a cornea and cataract specialist. If you had to choose a key word for cornea care in 2024, what would it be and why?

 I would use the word "exciting." There have been many innovations in terms of treating corneal disease more non-invasively, with more lamellar transplantation techniques. I would say what we can offer for patients with selective diseases of the cornea is is different than we could offer even, let's say, 15 years ago. I would say it’s exciting. It really is an innovative time. Hopefully in the near future, we'll see a day where, for example, we're not doing transplants, we're injecting cell-based therapies and so forth. But it's definitely been the less-invasive options for patients that I've seen over the evolution of my career as a cornea specialist, has been exciting and I'm looking forward to future innovations that lead to less-invasive solutions for our patients.

 Now, I know that your lecture on Saturday is capping off a really busy first full day of the meeting. There will be symposia on everything from practice management and patient accessibility to hot topics in ophthalmology. What are you most looking forward to this weekend?

 So this is one of my favorite meetings. And there is a lot of exchange of knowledge in terms of updates in every subspecialty by experts in the field. But I would say one of the highlights of the meeting is certainly the Brad Venable Excellence in Research program where the National Medical Association ophthalmology section sponsors 85 medical students to come attend the meeting and present. We will have a handful of them present their research. We already had a Saturday session where we heard several of their presentations that were selected for the paper presentations, and they selected the top three winners, as well as honorable mentions, to present. It's always wonderful to see and interact with these students who are the future of our field. It's a particular honor to see my mentee at Johns Hopkins, who is a third-year rising fourth-year medical student, who received first place for her work looking at faculty in academic ophthalmology and diversity. She'll be presenting, so I'm very excited to see her present and very proud of her for being selected out of a very competitive group. Everybody's presentations were really just inspiring. So that's going to be one of the highlights, definitely. 

We also are debuting a new faculty development program for underrepresented-in-medicine faculty called INTREPID, which stands for Investing, Training, Equipping and Promoting Individuals for Distinction in Ophthalmology. So this is a program that the NMA ophthalmology section started, along with the Association of University Professors of Ophthalmology [AUPO]. So Dr. Ore-ofe Adesina, Dr. Terri Young, Dr. Ahmara Ross and Dr. Dolly Padovani-Claudio started this program, which is meant for early faculty in academia, to expose them to the necessary skills, leadership and networking opportunities necessary to rise within the ranks of academia. Because the studies show that Black faculty are more likely to leave, less likely to be promoted, and again, less likely to be in higher positions such as full professor and chair. The number of full professors who are Black in ophthalmology can be counted in less than two hands. And then there are only three Black ophthalmology chairs, Dr. Terri Young being one of them. So, we chose our first cohort of six faculty from around the US. We're excited to interact with individuals and we have a whole program for them, including talking with a career coach, having leaders and faculty from the NIH and Research to Prevent Blindness as well as Dr. Kathy Colby, the chair of NYU, interact with our group. So I'm really excited about that.

And then we have a whole host of distinguished lectures. Dr. Stephanie Marioneaux will be giving the Patricia Bath Distinguished Lecture; where Dr. Roy Wilson will be honoring Robert Copeland, who's a cornea specialist and chair at Howard University. Dr. Basil Williams, who's the incoming chair, will be giving the Axel Hansen Distinguished Lecture. And finally Dr. Eydie Miller-Ellis, who is the division chief of glaucoma at Scheie as well as one of the leaders of the Rabb-Venable Excellence in Research Program along with Dr. [Mildred M.G.] Olivier, will be giving the Roger P. Mason Distinguished Lecture. We have an exciting meeting. There will be lots of young people, lots of distinguished ophthalmologists. So looking forward to, again, being the chair, seeing the executive committee, all the hard work—and it has been about a year of planning to get to this point. Our administrative team has been amazing. We've received a lot of support from industry and sponsors. So just grateful to see everyone and celebrate our Black ophthalmologists.

 Well, it sounds like "exciting" isn't just the keyword for cornea. It's for all of eye care, and especially this meeting! That's a lot to look forward to. Thank you so much for giving me a sneak preview, and for letting our audience know, if they can't make it this weekend, what they're missing and why they should come back next year.

Fasika Woreta, MD, discussed the Roman-Barnes lecture and the cornea care landscape ahead of the National Medical Association meeting.

Videos

NMA 2024: Outgoing ophthalmology chair Fasika Woreta, MD, sums up this year in cornea

They say a picture is worth a thousand works, and that is especially true for images of the retina. As technology has developed, retinal imaging has given ophthalmologists the power to catch vision damaging conditions earlier. In turn, this provides them the opportunities for early intervention treatments and potentially preserve vision for longer.

With the adoption of AI tools and the continued improvement of optical coherence tomography (OCT) technology, the retinal images that can be created are more powerful than ever. As we mark the halfway point of 2024, 

is taking a look at the news in imaging we’ve already seen this year.

In January, a kiosk model equipped with retinal imaging technology received 501K clearance from the U.S. Federal Drug Administration (FDA). According to the Pursuant Health’s press release on this device, the kiosk provides a guided interface to walk users through the process of capturing their retinal image. From there, licensed eye specialists can remotely access the images for analysis.

2. Using the retina for whole body prevention

As January ended, researcher from Mass Eye and Ear in Boston, Broad Institute, Massachusetts Institute of Technology, and Harvard University found that OCT imaging of the retina can help predict individuals’ risk of developing diseases, not only ocular conditions, but also heart, lung, metabolic, and neuropsychiatric illnesses. This research shows the value of regular eye exams with retinal imaging as well as the potential for early intervention and monitoring of conditions.

3. Portable fundus cameras empower on-call residents

On call residents at the Colorado University Department of Ophthalmology added portable cameras to their kits, bringing a reliable and valuable tool to their ability to care for patients. In discussing this decision, the university noted that the cameras have boosted the first evaluation of patients and facilitated follow-up care. Supervising physicians can also more easily see what the residents are seeing. Residents also discuss the images to weekly conferences to discuss the cases in academic settings.

4. Using swept-source anterior segment OCT imaging for uveitis

At the 2024 ARVO meeting in Seattle, Washington, Edmund Tsui, MD, spoke with the Eye Care Network team about a study looking at 67 eyes with varying grades of inflammation based on the standardization of uveitis nomenclature scale. The study used swept-source OCT imaging to look at the anterior chamber of the eyes and a customized algorithm to identify the amount of cells in each patient. The goal of this work it to use this technology to create a high-resolution, reproducible, objective, and quantifiable method to measure anterior chamber inflammation.

5. Imaging for patterns and early diagnosis

At the Retina World Congress meeting in Fort Lauderdale, Florida, Paulo-Eduardo Stanga, MD, spoke with Modern Retina to discuss his presentation, “New technologies for navigated peripheral OCT of the vitreoretinal interface and retina.” In this conversation, Stanga shared how using ultra widefield imaging is empowering researchers and those diagnosing patients to evaluate the different patterns in the retina and find correlations. These correlations are leading to more accurate, early diagnoses.

1. S. Crago. Pursuant Health received 510(k) clearance from FDA for kiosk offering self-service retinal imaging. Modern Retina. January 16, 2024. Accessed June 27, 2024. https://www.modernretina.com/view/pursuant-health-received-510-k-clearance-from-fda-for-kiosk-offering-self-service-retinal-imaging

2. L. Charters. OCT predicts eye, heart, lung, metabolic, neuropsychiatric diseases. Modern Retina. Published January 30, 2024. Accessed June 27, 2024. 

https://www.modernretina.com/view/oct-predicts-eye-heart-lung-metabolic-neuropsychiatric-diseases

3. D. Hutton. CU Ophthalmology residents employ portable fundus photography cameras to enhance on-call imaging. Modern Retina. Published March 4, 2024. Accessed June 27, 2024. 

https://www.modernretina.com/view/cu-ophthalmology-residents-employ-portable-fundus-photography-cameras-to-enhance-on-call-imaging

4. ARVO 2024: Analysis of anterior chamber inflammation through automated quantitative assessment of swept-source anterior segment OCT images. Modern Retina. Published May 20, 2024. Accessed June 27, 2024. 

https://www.modernretina.com/view/arvo-2024-analysis-of-anterior-chamber-inflammation-through-automated-quantitative-assessment-of-swept-source-anterior-segment-oct-images

5. RWC 2024: New technologies for navigated peripheral OCT of the vitreoretinal interface and retina. Modern Retina. Published May 12, 2024. Accessed June 27, 2024. https://www.modernretina.com/view/rwc-2024-new-technologies-for-navigated-peripheral-oct-of-the-vitreoretinal-interface-and-retina

From AI tools and early diagnoses to advancing image rendering and predicting overall health, retinal imaging is reaching new heights.

The big picture: 5 ways retinal imaging is progressing

ASRS 2024: Socioeconomic characteristics associated with presenting visual acuity and foveal status in rhegmatogenous retinal detachment

 about her research titled, "Individual and neighborhood-level socioeconomic characteristics associated with presenting visual acuity and foveal status in rhegmatogenous retinal detachment" at the annual ASRS meeting in Stockholm, Sweden.

Hi, my name is Dr. Sally Ong from the Atrium Health Wake Forest Baptist Hospital in Winston-Salem, North Carolina. In our study, we looked at the association between individual and neighborhood-level social determinants of health with visual acuity, as well as foveal status at presentation of rhegmatogenous retinal detachments that were repaired at the Wilmer Eye Institute over a 10 year period.

This was a retrospective cohort study that was done in adult patients. We mapped home addresses to social determinants of health and did multivariable logistic regression to look at associations between these social determinants of health as well as with vision and foveal status at presentation of rhegmatogenous retinal detachments. Specifically, we did this study because there has been reports of relationships between vision outcomes, with social determinants of health in other ophthalmic conditions such as cataract, glaucoma, diabetic retinopathy, and macular degeneration. But not much has been looked at in terms of retinal detachments. And we really wanted to see how social determinants of health can affect vision outcomes in retinal detachments.

What we found was that there is a relationship between older age with vision at presentation. Older age was associated with worse vision at presentation, worse than 20/40. Older age was also associated with foveal involvelment at presentation. There was no difference in sex between the groups. Race and ethnicity wise, there was an association with vision at presentation. Non-Hispanic Black patients at higher proportions presented with vision worse than 20/40 compared to Non-Hispanic White patients. In terms of insurance status, we also found that patients who have public insurance, higher proportions presented with vision worse than 20/40 compared to patients with private insurance. So that was on the individual level. And we accounted for the individual level characteristics; age, sex, and ethnicity, and insurance status. We looked at a multitude of neighborhood level social determinants of health. And we found associations with vision and foveal status at presentation with 3 social determinants of health. Specifically, the 3 are area deprivation index–number 1. Percentage of workers who drove to work–number 2. Third would be per capita income. And what we found was that, first of all, for every increase in area deprivation index, which really is a marker for more social economic deprivation, there was an increased predicted probability of presenting with vision worse than 20/40 as well as presenting with foveal involving rhegmatogenous retinal detachments.

Secondly, we found that for every percentage increase in workers who drove to work in the neighborhood, there was increased predictive probability of presenting with vision worse than 20/40 and also presenting with foveal involving retinal detachments.

Thirdly, we found that for every $1,000 increase in per capita income, there was a decrease in predicted probability of presenting with vision worse than 20/40. However, there was no relationship between per capita income and foveal status at presentation of retinal detachment.

So we think in summary, 3 big takeaways from our study was that–First of all, there is an association between socioeconomic deprivation, as reflected by the higher ADI scores with worse retinal detachments at presentation, as reflected by worse vision, and foveal involvement. And secondly, we found that for workers who lived in neighborhoods where a car is needed to drive to work, patients don't have cars in those neighborhoods. They might have challenges accessing health care, and that may be why they present later in disease with worse vision, as well as with foveal enlargement. We thought that was an interesting finding. So people who don't have cars, but live in neighborhoods where cars are required, may have challenges assessing health care. The third finding that we found in terms of the association between higher per capita income was less likelihood presenting with worse vision, but that not really having an association with foveal status. We think that may be a reflection of the fact that patients with higher per capita income are more likely to have cataract surgery. So we think that relationship might be confounded by higher rates of cataract surgery, since we didn't find an association between per capita income with foveal involvement at presentation.

So all in all, I think our study really highlights how important it is to first of all identify some of the socioeconomic barriers that patients may face in terms of accessing health care to allow them to present earlier in disease. Because we know that patients who present later in disease specifically in rhegmatogenous retinal detachments, they may face higher complication rates in terms of you know, developing proliferative vitreoretinopathy, which would decrease their single surgery, anatomic success. And put them on this pathway of needing repeat surgeries. Our findings really highlight how important it is to first of all identify those barriers in terms of health. And that may help us in the long run, really be able to speak to our public policymakers and help them design public policies that may be able to target this vulnerable populations to help them better access health care, so that they can really you know, present earlier in disease and have better health outcomes.

Sally S. Ong, MD, spoke with Modern Retina about her research titled, "Individual and neighborhood-level socioeconomic characteristics associated with presenting visual acuity and foveal status in rhegmatogenous retinal detachment" at the annual ASRS meeting in Stockholm, Sweden.

Daniel F. Kiernan, MD, FACS

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