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Advancements in ocular drug delivery

The 2024 American Academy of Ophthalmology meeting is set to take place in Chicago, Illinois from October 18 through October 21, 2024. At this meeting, there will be many announcements from ophthalmic companies and presentations on data from clinical trials. Ahead of this event, there have been several announcements sharing what these presentations will discuss and the information in exhibition.

The following list is non-exhaustive and ordered alphabetically.

The company will share results from its clinical studies of investigational oral gildeuretinol for the treatment of geographic atrophy secondary to age-related macular degeneration (SAGA) and Stargardt disease (TEASE) during the meeting.

Gildeuretinol in geographic atrophy: Results from SAGA, a 2-year, randomized, double-masked, placebo-controlled 

Deuterated vitamin A preserves vision in Stargardt disease (TEASE Study)

Annexon will present new analyses of ANX007 from the completed Phase 2 ARCHER trial in geographic atrophy (GA). ANX007 is a first-in-kind, non-pegylated antigen-binding fragment (Fab) designed to block C1q locally in the eye with an intravitreal formulation.

Presenter: Douglas Love, Annexon Biosciences

Preservation of vision by ANX007: Clinical results and anatomical changes from the phase 2 ARCHER trial

Presenter: Dr. Rahul N. Khurana, Northern California Retina Vitreous Associates and UCSF Medical Center Department of Ophthalmology, California, US

Safety and efficacy data on ATSN-201 for the treatment of X-linked retinoschisis (XLRS) will be presented at the event. ATSN-201 leverages AAV.SPR, the company’s novel spreading capsid, to achieve therapeutic levels of gene expression in photoreceptors of the central retina while avoiding the surgical risks of foveal detachment.

Interim Safety and Efficacy of ATSN-201 Dose Escalation Study in Patients With X-linked Retinoschisis (XLRS)

The company will participate in the exhibition hall to showcase the progress of the ABI gene therapy ocular programs. Avirmax Biopharma has innovated proprietary AAV2.N54 capsids optimized for superior gene delivery to the macula retina on basis of AAV2.

Avirmax Biopharma's lead candidate ABI-110 for wet AMD is currently enrolling patients for Phase I/IIa trials in the US (NCT06550011). It has shown significantly improved tropism to the macular retina over wildtype serotypes and AAV2.7m8 in mice, rabbits, pigs, and non-human primates. The ABI-201 programs for geographic atrophy (GA), dry AMD, proliferative diabetic retinopathy (PDR), and the ABI-902 pipeline targeting multiple types of glaucoma are currently under nonclinical development.

The company has announced a poster presentation of the 24-month interim safety and efficacy results of the Phase 2 SKYLINE trial in patients with XLRP. This poster is entitled, “Subretinal AGTC-501 Gene Therapy for XLRP: 24-Month Interim Results of the Phase 2 SKYLINE Trial” and is authored by Robert Sisk, MD, FACS, FASRS.

The 24-month data showed a response rate of 57% (4/7) in study eyes treated with a high dose (6.8 E+11 vg/eye) of AGTC-501, defined as a patient who has an improvement in retinal sensitivity as assessed by microperimetry of at least 7 decibels (dB) in at least 5 loci. Patients in the high-dose cohort also showed a robust improvement in mean retinal sensitivity. Study eyes treated with a low dose (7.5 E+10 vg/eye) of AGTC-501 showed a response rate of 25% (1/4). There were no clinically significant safety events associated with AGTC-501 treatment in this trial, and any treatment-emergent adverse events were mostly non-serious and mild to moderate in severity.

Belite Bio will present data from its completed Phase II adolescent Stargardt disease trial at the American Academy of Ophthalmology Annual Meeting.

Tinlarebant (LBS-008) for Adolescents with Stargardt Disease

Arie Crown Theater (Lakeside Center building, 1F), Chicago, IL

Investigation of an Oral Retinol Binding Protein 4 Antagonist in the Treatment of Childhood-onset Stargardt Disease

The company will deliver a presentation detailing the results of a successful Phase 3 study (CPN-302) of clobetasol propionate suspension 0.05% (APP13007) that led to its approval by the FDA as a treatment for inflammation and pain following ocular surgery. Eyenovia announced the US launch and commercial availability of clobetasol on September 26, 2024.

Clobetasol Propionate Ophthalmic Suspension 0.05% (APP 13007) for the Treatment of Postsurgical Inflammation and Pain (Study CPN-302)

LENZ Therapeutics will present on LNZ100 during the Eyecelerator event at AAO 2024. LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine. The candidate achieved all primary and secondary endpoints in the registration-enabling Phase 3 CLARITY study as a potential therapy for the treatment of presbyopia.

CLARITY Phase 3 study data of LNZ100 for the treatment of presbyopia

Presenter: Marc Odrich, MD, Chief Medical Officer, LENZ Therapeutics

The company is set to share end-of-study topline data from Nanoscope's RESTORE, a randomized-controlled trial (RCT) of MCO-010 therapy in patients with severe vision loss due to retinitis pigmentosa (RP). RESTORE is the first-ever RCT to show statistically significant visual acuity improvement in this patient population and a key part of the upcoming BLA submission planned for Nanoscope's RP program.

Efficacy and Safety of MCO-010 Optogenetic Therapy for Vision Restoration in Patients with Severe Vision Loss Due to RP: Two-Year TOPLINE Results from a Phase 2b/3 Randomized, Sham-Controlled Clinical Trial (RESTORE)

ZEISS Medical Technology will showcase digital enhancements and revolutionary surgical solutions at the AAO conference. According to the company, these innovations across cataract, corneal refractive, retina, and glaucoma workflows, offer new, enhanced paths to patient management and treatment, using a digitally connected environment to help advance the clinical workflow to support a higher level of personalized care.

Alkeus Pharmaceuticals Announces Data Presentations at the American Academy of Ophthalmology (AAO) 2024 Annual Meeting, October 18-21 in Chicago. Alkeus Pharmaceuticals. October 17, 2024. Accessed October 17, 2024. https://www.globenewswire.com/en/news-release/2024/10/17/2964857/0/en/Alkeus-Pharmaceuticals-Announces-Data-Presentations-at-the-American-Academy-of-Ophthalmology-AAO-2024-Annual-Meeting-October-18-21-in-Chicago.html

Annexon to Present New Phase 2 ARCHER Data for ANX007 in Dry AMD Patients with Less Advanced GA at the American Academy of Ophthalmology 2024 Meeting. Annexon, Inc. October 15, 2024. Accessed October 17, 2024. 

https://www.globenewswire.com/news-release/2024/10/15/2963132/0/en/Annexon-to-Present-New-Phase-2-ARCHER-Data-for-ANX007-in-Dry-AMD-Patients-with-Less-Advanced-GA-at-the-American-Academy-of-Ophthalmology-2024-Meeting.html

Atsena Therapeutics to Present ATSN-201 Safety and Efficacy Data at the American Academy of Ophthalmology 2024 Annual Meeting. Atsena Therapeutics. October 10, 2024. Accessed October 17, 2024. https://www.globenewswire.com/en/news-release/2024/10/10/2961204/0/en/Atsena-Therapeutics-to-Present-ATSN-201-Safety-and-Efficacy-Data-at-the-American-Academy-of-Ophthalmology-2024-Annual-Meeting.html

Avirmax Biopharma Inc. to Exhibit Development of Next Generation Gene Therapies for Ocular Diseases at the AAO 2024 Annual Meeting in Chicago. Avirmax Biopharma Inc. October 15, 2024. Accessed October 17, 2024. https://www.prnewswire.com/news-releases/avirmax-biopharma-inc-to-exhibit-development-of-next-generation-gene-therapies-for-ocular-diseases-at-the-aao-2024-annual-meeting-in-chicago-302277135.html

Beacon Therapeutics Announces Positive 24-Month Data from Phase 2 SKYLINE Trial of AGTC-501 in Patients with X-Linked Retinitis Pigmentosa. Beacon Therapeutics Holdings Limited. October 15, 2024. Accessed October 17, 2024.

Belite Bio Announces Presentations at the American Academy of Ophthalmology 2024 Annual Meeting. Belite Bio, Inc. October 14, 2024. Accessed October 17, 2024. 

https://www.globenewswire.com/news-release/2024/10/14/2962506/0/en/Belite-Bio-Announces-Presentations-at-the-American-Academy-of-Ophthalmology-2024-Annual-Meeting.html

Eyenovia Announces Presentation of Phase 3 Clobetasol Study Results at the American Academy of Ophthalmology (AAO) 2024 Expo. October 16, 2024. Accessed October 17, 2024. 

https://www.globenewswire.com/en/news-release/2024/10/16/2963893/0/en/Eyenovia-Announces-Presentation-of-Phase-3-Clobetasol-Study-Results-at-the-American-Academy-of-Ophthalmology-AAO-2024-Expo.html

LENZ Therapeutics Announces Presentations at Upcoming Ophthalmology and Optometry Medical Conferences. LENZ Therapeutics, Inc. September 30, 2024. Accessed October 17, 2024. 

https://www.globenewswire.com/en/news-release/2024/09/30/2955160/0/en/LENZ-Therapeutics-Announces-Presentations-at-Upcoming-Ophthalmology-and-Optometry-Medical-Conferences.html

Nanoscope Announces Presentations at the American Academy of Ophthalmology Annual Meeting 2024. Nanoscope Therapeutics, Inc. October 15, 2024. Accessed October 17, 2024. 

https://www.prnewswire.com/news-releases/nanoscope-announces-presentations-at-the-american-academy-of-ophthalmology-annual-meeting-2024-302273411.html

ZEISS expands ophthalmic offerings to improve patient care with new digital AI tools and revolutionary surgical solutions. October 9, 2024. Accessed October 17, 2024. https://www.prnewswire.com/news-releases/zeiss-expands-ophthalmic-offerings-to-improve-patient-care-with-new-digital-ai-tools-and-revolutionary-surgical-solutions-302271146.html

The annual American Academy of Ophthalmology meeting will include notable data and announcements for many companies in the ophthalmic space as they discuss upcoming and ongoing clinical trials as well as corporate and product developments.

10 more companies share upcoming AAO presentation information

AAO 2024, Kelman Lecture, medical education evolution, AI in medicine, robotics, continuous clinician education, "See One, Do One, Teach One" model, healthcare training innovation, Bonnie An Henderson, ophthalmology education

AAO 2024: Bonnie An Henderson, MD, explores future of medical education in Kelman Lecture

Bonnie An Henderson, MD, shares insights for her Kelman Lecture, titled Enhancing the Paradigm of 'See One, Do One, Teach One' with Technology, at the 2024 American Academy of Ophthalmology meeting, October 18 to 21 in Chicago, Illinois. 

Henderson emphasizes the evolution of medical education, reflecting on her own experiences from a time before the internet to the current landscape enriched by digital tools and advancements in artificial intelligence and robotics. She is a clinical professor at the Tufts University School of Medicine in Boston, Massachusetts.

Henderson highlights the transformative journey of medical training. She discusses the shift from traditional learning methods, such as textbooks and lectures, to modern resources like simulators and online platforms. The advent of AI presents an exciting future for education, allowing for the rapid accumulation and dissemination of knowledge.

She offers advice to residents, stressing the importance of diverse educational modalities. She adds that individuals learn differently, and while visual resources like YouTube can be helpful, hands-on experience remains vital. Practicing skills through wet labs, synthetic models, or simulators is crucial for developing the necessary hand-eye coordination and physical dexterity.

Henderson underscores the necessity of continuous learning in a rapidly evolving field. She encourages them to engage with various educational opportunities, whether online or in-person, to stay current with the latest devices, techniques, and medications. With medical advancements accelerating every six months, maintaining up-to-date knowledge is essential for providing optimal patient care and enhancing professional practice. 

Henderson’s presentation touches on the shift in medical education from traditional learning to AI and robotics.

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AAO 2024: Epimacular membranes and metamorphopsia

At this year's American Academy of Ophthalmology (AAO) meeting, Jonathan Brugger, MD, spoke about the changing approach to epimacular membranes and the use of brilliant blue in the procedure.

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

I'm Dr Jonathan Brugger. I'm a vitreoretinal surgeon with Carolina Eye Care in Charleston, South Carolina. And I wanted to shed some light on epimacular membranes. A lot of the teaching that we have been taught in generations was that "we don't want to touch epimacular membranes until they are visually significant." 

However, with safer procedures, better instruments, and now non-toxic, brilliant blue, we should be having earlier intervention on epimacular membranes, to the point that surgeons now are approaching patients that are symptomatic with metamorphopsia to peel even [a] 20/20 vision eye. That's simply because individuals can see that it's the letter T, whether it's perfectly straight or if it's slightly twisted, but the patients now that we are peeling early, have quicker resolution of their metamorphopsia and report that the vision is actually better, that the T is straight, if you will, and we have not caused any harm to the retina. With the non-toxic brilliant blue, we feel confident that we're getting all of the membrane because we're able to re-stain multiple times. 

The adage of "waiting until the membrane gets bad enough," you will be sitting there for a lifetime, because we do know that a majority of these membranes will form and then they do not progress. So you will be watching these patients for years and years and years that are symptomatic but not getting better. And now, I think the time has come that we should start looking at this again for early intervention of peeling symptomatic epimacular membranes.

Diabetic retinopathy has tended to be regarded as a rare occurrence in young patients diagnosed with diabetes, but a recent paper details the growing rates of the disease in young people as a looming “potentially unappreciated public health catastrophe.”

, coauthored by Julie M. Rosenthal, MD, MS, from the University of Michigan Department of Ophthalmology and Visual Sciences and Kellogg Eye Center, pointed to data from 2 recent studies, including the Treatment Options for Type 2 Diabetes in Adolescents and Youth study and the SEARCH for Diabetes in Youth study.

“Diabetic retinopathy in young people is more common than we originally thought,” Rosenthal said in a University of Michigan news release. “So we need to take action by screening for it and intervening when we are able.”

Diabetic retinopathy occurs when high blood sugar damages tiny blood vessels and nerves in the retina, the structure at the back of the eye that acts like the sensor in a digital camera. It can result in vision loss that can be permanent and blinding.

According to the University of Michigan news release, the most effective way to reduce the risk of diabetic retinopathy, according to experts, is to effectively manage the patient’s diabetes.

“In youth-onset Type 1 or Type 2 diabetes, we used to think it was rare to have retinopathy, but we’re finding out more and more that’s just not the case,” Rosenthal explained. “These two major studies found that after just 12 or 13 years of having diabetes, at least 50% of people had some amount of retinopathy, which is unexpectedly and unacceptably high.”

Rosenthal and her co-authors, retina specialist Jennifer K. Sun, MD, MPH, of Harvard, and pediatric endocrinologist Risa M. Wolf, MD, wrote in the paper that among participants in the studies who have Type 2 diabetes, the SEARCH and TODAY studies combined found that 49% to 55% had diabetic retinopathy after having diabetes for only about 12 to 13 years.

In the SEARCH study, 52% of youths with type 1 diabetes had DR. For participants with type 2 diabetes, at a mean 7.5 years after diagnosis, the standardized prevalence of DR was 31%, increasing to 55.7% at a mean 12.4 years after diagnosis.

This was a surprise to investigators, as earlier data from one of the studies at 7 years after diagnosis only showed a rate of 4% to 13%.

Even though much of that retinopathy isn’t immediately threatening to vision, Rosenthal added, “that’s way more than we ever thought before, and given the increasing number of people who have diabetes, and especially with the prevalence of Type 2 diabetes going up, this is something we really need to pay attention to as ophthalmologists and as pediatric endocrinologists.”

Rosenthal acknowledged that it can be a challenge to maintain control of diabetes – especially during the years when diabetic retinopathy can begin taking a toll on the vision of young adult patients.

Moreover, for many patients, life is changing and events such as establishing their own homes, going off to college, starting a new job, or even transitioning from a pediatric endocrinologist to an adult doctor can all get in the way of closely monitoring a dangerous, progressive disease.

Rosenthal pointed out that diabetes is not an easy disease to live with because it impacts every part of a person’s life.

“When your friends aren’t having to deal with this, when you want to be living your life like a normal 18-, 20-, or 22-year-old, it can be really tough to get to your screening exams and keep good control of the disease,” she said.

Rosenethal added that researchers are worried that the disparities that are already present are going to widen if action is not taken.

“We need to make sure people are able to see their doctors and find better ways to get the treatment and the screening that they need,” she said.

That said, it’s important to both control the illness and know whether retinopathy may be progressing.

“While we think that control over blood sugar is a big factor in preventing retinopathy, we know it’s not the only one,” Rosenthal said.

Early screenings and detection can allow ophthalmologists to intervene during the earliest stages of diabetic retinopathy, even before patients have lost vision, suffered a retinal detachment or have had a lot of bleeding in the back of the eye. Rosenthal noted that that early intervention can lead to treatments that may prevent those things from happening and permanently affecting a patient’s vision at such a young age.

Black, Hispanic youths disproportionately affected

While the incidence of both types of diabetes in youths has risen over the past 2 decades, the greatest increase has been among Black and Hispanic youths, a trend that’s projected to continue in coming years.

Diagnoses of Type 1 diabetes are projected to increase 65%, while Type 2 diagnoses may shoot up more than 600%, according to the paper.

Studies also indicate that racial and ethnic minority groups bear a heavier burden of diabetic retinopathy than their white peers.

“We’re very concerned that the disparities that are already present are going to widen if we don’t take action,” Rosenthal said. “We need to make sure people are able to see their doctors and find better ways to get the treatment and the screening that they need.”

Improved screening methods lead to better outcomes

The traditional methods of screening for diabetic retinopathy include examining the retina or taking a picture of the back of the eye to check for changes including bleeding, swelling, tiny aneurisms or patches of the retina that aren’t getting great blood flow.

In recent years, physicians have started to view diabetic retinopathy as more of a problem affecting a “neurovascular unit” of nerves and blood vessels working together.

“We haven’t been looking at the neurologic part of retinopathy,” Rosenthal pointed out, by using tests like contrast sensitivity – for example – trying to see a letter that’s getting closer to the same color as the background.

“Is there something happening in the retina before we’re even seeing the retinopathy that could be affecting these young people?” she asked.

According to the University of Michigan news release, recent studies in adult patients have highlighted changes in how the retina works that ultimately may come before retinopathy is visible on exam or photographs.

Rosenthal further noted she would like to see more and better screening done in ways that make it easier for patients to stay on top of their eye health.

“We need to take screening to where patients already are—at their pediatric endocrinologists’ office or primary care physician, so they don’t have to make an extra trip to the eye doctor,” she explained.

Rosenthal also noted that the young patients and their parents are faced with a number of hurdles to clear when the child is diagnosed with retinopathy, and this could help check one item off their list.

“Many programs such as this are already underway for adults,” she said.

While current treatment options are better today than they were even 10 or 15 years ago, Rosenthal concluded that these treatments remain more reactive than preventative. In the future, Rosenthal said she hopes to have effective treatments that can act at earlier stages of the disease.

Rosenthal JM, Sun JK, Wolf RM. Diabetic Retinopathy in Youths—A Potentially Unappreciated Public Health Catastrophe. 

 Published online October 3, 2024. Accessed October 10, 2024. doi:10.1001/jamaophthalmol.2024.387

Diabetic retinopathy is being diagnosed more in younger patients. Michiganmedicine.org. Published October 9, 2024. Accessed October 10, 2024. https://www.michiganmedicine.org/health-lab/diabetic-retinopathy-being-diagnosed-more-younger-patients?amp

A recent paper reveals increasing rates of diabetic retinopathy in young patients with diabetes, sparking concerns over inadequate screening and management, especially among Black and Hispanic youths. 

Rising diabetic retinopathy rates in youth signal potential public health crisis

Real-world treatment outcomes from a study of patients with retinal vein occlusion

At this year's American Society of Retina Specialists (ASRS) meeting, the Eye Care Network spoke with consultant ophthalmologist Christiana Dinah, BSc, MB BS, MRes. Her presentation focused on real-world outcomes of anti-vascular endothelial growth factor (VEGF) therapies for patients with retinal vein occlusion.

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

 Hi my name is Christiana Dinah. I'm a consultant ophthalmologist at London North West Trust, in London, United Kingdom. It is my pleasure to present, at ASRS 2024, our work on the real-world outcomes with anti-VEGF therapy in retinal vein occlusion in the United Kingdom. We know the retinal vein occlusion is a significant cause of visual impairment, being the second most common retinal vascular disease, second only to diabetic retinopathy. We are fortunate to have anti-VEGF therapy now, with significantly beneficial results in pivotal randomised controlled trials. 

However, these results have often been difficult to translate in the real world. Additionally, there is sparse data on long-term, real-world outcomes with anti-VEGF therapy in the context of retinal vein occlusion. We extracted data from 16 geographically dispersed eye clinics in the United Kingdom. Our study included approximately 3500 patients in the [branch retinal vein occlusion] BRVO arm and a similar number in the [Central Retinal Vein Occlusion] CRVO arm, so this is quite a large sample size. However, the proportion with follow-up out to 5 years was closer to 500 eyes in each cohort. We included patients that were treatment-naive to any treat previous treatment for retinal vein occlusion, who had had at least 1 anti-VEGF therapy within the timeframe of the study, and had a minimum of 3 month follow-up and up to 60 months follow-up, and that is 5 years. 

Importantly, in the United Kingdom at the moment, the only approved anti-VEGF therapies for retinal vein occlusions are aflibercept, ranibizumab and bevacizumab. So these were the anti-VEGF therapies that we looked at, as under the umbrella of anti-VEGF. To our results, there was significant visual gain, with the average visual acuity gain of approximately 11 to 13 letters in both the branch retinal vein occlusion groups and the central retinal vein occlusion groups. And this was demonstrated quite early, within 3 months, and maintained up to around 12 to 18 months, at which point the visual acuity gains start to reduce slowly, and by the time we get to month 60, that is 5 years, the visual gains at that point is approximately 7 to 8 letters, almost half of the initial gains. We next looked at the number of injections delivered on average in the first year. In both the BRVO cohort and the CRVO cohorts a mean number of 6.4 to 6.5 injections were delivered. And this reduced over the follow-up period to approximately 2.5 injections in both cohorts in the year 5. 

We delved deeper by stratifying the cohorts into low injection receivers, medium injection receivers and high injection receivers. The low cohort received less than 4 injections in within a 12 month period, the medium 4 to 8, and the high greater than 8 injections, and we demonstrated the high cohort reported visual gains similar to what we've seen in the clinical trials that into 15 letter gains, whilst the low cohort reported approximately half of that, and this pattern was evident right out to month 60. Additionally, eyes receiving intravitreal steroids and macular laser increased gradually from year 1 through to year 5, suggesting efforts to achieve or maintain disease control right out to year 5. 

Our study strengths include a large heterogeneous population in a geographically dispersed population across United Kingdom, but limitations include the lack of anatomical data, in addition to a loss to follow-up, whereby the proportion of eyes at the start is approximately 3500 in the BRVO, and in the CRVO, separately whilst at year 5, we have approximately 500 eyes in each arm. The take home message is anti-VEGF therapy does work in retinal vein occlusion and translates into the real-world. However, there are factors limiting our ability to deliver the same volume of injections, as in the randomised control trials. Therefore, there's an unmet need for sustained durable treatments for retinal vein occlusions and long-term monitoring to ensure disease control. Thank you.

Consultant ophthalmologist Christiana Dinah, BSc, MB BS, MRes, presented research findings on retinal vein occlusion in the United Kingdom

ASRS 2024: Real-world treatment outcomes from a study of patients with retinal vein occlusion

ASRS 2024: Intraoperative fluorescein angiography reduces the rate of postoperative vitreous hemorrhage

Alan Franklin, MD, PhD, FASRS, spoke about his presentation, "Intraoperative Fluorescein Angiography Reduces the Rate of Postoperative Vitreous Hemorrhage" at this year's American Society of Retina Specialists (ASRS) meeting in Stockholm, Sweden. 

Hi I'm Alan Franklin, MD, PhD. FASRS, I practice at Diagnostic and Medical Clinic in Mobile, Alabama, [and I] had the opportunity to present intraoperative fluorescein angiography, how that's improving our outcomes in diabetic vitrectomy at this great venue in Stockholm, Sweden. intraoperative fluorescein angiography, was initially described by Steve Charles 20 to 30 years ago, with the advent of digital visualization, it's gotten more traction as our visualization is better. The images and the video on the operating room are quite compelling, but the question begs is even though the video is great, and shows us reproducible biomarkers that we see in clinic, will it help her outcomes.

So we did a study where we looked at our diabetic patients and looked at rate of vitreous hemorrhage after vitrectomy with or without fluorescein angiography guidance intraoperativly of laser and other surgical maneuvers. Indeed, we found that fluorescein angiography reduced our post-op vitreous hemorrhage rate greatly, especially over the first 1 to 2 months with corresponding better vision reported rate with fluorescein guidance during the surgery is on the order of 10%, which is much lower than the standard reported rates after vitrectomy surgery for diabetic retinopathy and we both Dr. Abruro, our colleague and Dominican Republic, and we showed a significant reduction and rates of vitreous hemorrhage after surgery compared to those who did not receive intraoperative fluorescein angiography before surgery, it was highly significant, especially at both the 1- and the 2-month time points And that we had about 90 patients that underwent fluorescein angiography, so it's still a relatively large study. It is limited by the retrospective nature.

Hopefully it'll improve adoption. It's one thing to show pretty pictures and videos, but to show and prove surgical outcomes, hopefully will will get better adoption. We need to work on making this available for both digital visualization platforms and standard optical visualization with a surgical microscope as well.

Dante Pieramici, MD

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