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Clinical

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Pedro Fonseca, MD, Coimbra Hospital and University Centre, Portugal, and Andrew G. Lee, MD, Blanton Eye Institute, Houston Methodist, Texas, USA, discuss the various pros and cons of offering teprotumumab for all patients with thyroid eye disease. 

COPHy 2023: Weighing the merits of offering teprotumumab for all patients with thyroid eye disease

Retina World Congress 2025 will take place May 8-11. As researchers prepare for their, presentation, we are highlighting the upcoming sessions that are scheduled for this meeting, which will be held in Fort Lauderdale, Florida.

Note: The following list of presentations are in alphabetical order by company. Updates will be added to this article as new information becomes available.

The company highlight Phase 2 results for migaldendranib (MGB), Ashvattha’s investigational subcutaneous treatment for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). The presentation, entitled, "Emerging Data om Anti-angiogenic Nanomedicine (Migaldendranib MGB/D-4517.2) for AMD and DME" will be given by Michael Singer, MD on Sunday, May 11, 2025; 11:11 – 11:16 am ET.

Phase 2 clinical data demonstrated that MGB administration lowered production of subretinal fluid reducing or eliminating the need for intravitreal anti-VEGF treatment in both the study eye and fellow eye in wet AMD and DME subjects with bilateral disease. New data indicates that MGB may be the first safe systemic therapy for the treatment of wet AMD and DME without ocular adverse events.

Huma Qamar, Chief Medical Officer at Ocugen will represent Ocugen at Retina World Congress to share a presentation and join retinal surgeons and industry peers during a panel discussion.

Inherited and Rare Retinal Diseases Session
Moderated by Rishi P. Singh, MD, FASRS and Kourous A. Rezaei, MD on Thursday, May 8, 2025, 10:35 – 11:12 AM ET

Ocular Therapeutix will present information at the meeting in Fort Lauderdale regarding the axitinib intravitreal hydrogel clinical trials, the use of its candidate OTX-TKI for diabetic retinopathy, and the HELIOS clinical trial for diabetic retinopathy.

Axitinib Intravitreal Hydrogel: Update on Clinical Trials

Presented by Carl C. Awh, MD, FASRS, on Friday, May 9, 2025, 4:33 – 4:38 PM ET.

Presented by Dilsher S. Dhoot, MD, FASRS on Saturday, May 10, 2025, 8:44 – 8:49 AM ET

Volumetric Macular Fluid Analysis of the Impact of a Single Axitinib Intravitreal Injection (OTX-TKI) from the HELIOS Clinical Trial for Diabetic Retinopathy

Presented by Carl J. Danzig, MD on Saturday, May 10, 2025, 8:52 – 8:57 AM ET

The company will present further insights from Stage 1 of the Phase 3 DIAMOND program reinforcing the efficacy and safety profile of OCS-01 eye drops for DME will also be shared. OCS-01 is being developed to be the first non-invasive treatment for DME, addressing key unmet needs for earlier treatment intervention and for inadequate responders to the current standard of care.

Ashvattha Therapeutics to Present at ARVO, Retina World Congress, and AOS Annual Meeting. Ashvattha Therapeutics. April 15, 2025. Accessed April 16, 2025. https://www.globenewswire.com/news-release/2025/04/15/3061682/0/en/Ashvattha-Therapeutics-to-Present-at-ARVO-Retina-World-Congress-and-AOS-Annual-Meeting.html

Ocugen to Present on Modifier Gene Therapy Platform at Association for Research in Vision and Ophthalmology 2025 Annual Meeting and Retina World Congress. Ocugen Inc. April 29, 2025. Accessed April 30, 2025. https://www.globenewswire.com/news-release/2025/04/29/3070074/0/en/Ocugen-to-Present-on-Modifier-Gene-Therapy-Platform-at-Association-for-Research-in-Vision-and-Ophthalmology-2025-Annual-Meeting-and-Retina-World-Congress.html

Ocular Therapeutix™ to Participate in Upcoming Investor and Scientific Conferences. Ocular Therapeutix. April 29, 2025. Accessed April 29, 2025. https://www.globenewswire.com/news-release/2025/04/29/3070022/0/en/Ocular-Therapeutix-to-Participate-in-Upcoming-Investor-and-Scientific-Conferences.html

Oculis to Present its Innovative Late-Stage Pipeline Candidates at Upcoming Ophthalmology Conferences. Oculis Holding AG. May 1, 2025. Accessed May 1, 2025. https://www.biospace.com/press-releases/oculis-to-present-its-innovative-late-stage-pipeline-candidates-at-upcoming-ophthalmology-conferences

Companies working in the retina space have announced that data from clinical trials will be shared at this year’s meeting in Fort Lauderdale, Florida.

RWC 2025: Companies to share data at meeting in Fort Lauderdale

A recent nationwide registry study of women with type 1 diabetes, pregnant women, and retinopathy-matched, nonpregnant control participants had a similar risk of developing sight-threatening 

The objective of the study was to evaluate the risk of treatment of sight-threatening DR, defined as panretinal photocoagulation for proliferative DR or anti-VEGF injections for diabetic macular edema (DME) during and after pregnancy, compared with nonpregnant control participants.

Using the national Danish Registry of Diabetic Retinopathy during and after pregnancy, investigators created a matched cohort study of women with type 1 diabetes who gave birth in 2013-2022. A total of 1041 pregnant women and 1041 matched control participants were included. The data were collected from relevant national registers from 36 months before pregnancy until 36 months after pregnancy.

At baseline, the median duration (IQR) of diabetes was 13 (6, 19) and 10 (5, 17) years for cases and control participants. Median baseline hemoglobin A

 (IQR) was 57 (50, 67) compared with 64 (55, 79) mmol/mol (7.4% vs. 8%), and DR was present in 42.7% of both groups.

Investigators found that treatment of proliferative DR with panretinal photocoagulation occurred to a similar extent in both pregnant women vs control participants during and after pregnancy. During treatment: 1.2% vs 1.1%, respectively, (OR, 1.18; 95% CI, 0.53, 2.66); and after treatment: 2.7% vs 2.9%, respectively, (OR, 0.93; 95% CI, 0.55, 1.57).

 Treatment of DME was rare in both groups. Progression to proliferative DR was not higher in the pregnant group (adjusted HR, 0.64 [95% CI, 0.32, 1.31]).

Sight-Threatening Diabetic Retinopathy During and After Pregnancy – A Nationwide Matched-Cohort Study. Published August 26, 2025. Accessed September 2, 2025. 

https://diabetesjournals.org/care/article/doi/10.2337/dc25-0758/163308/Sight-Threatening-Diabetic-Retinopathy-During-and

A study reveals similar risks of sight-threatening diabetic retinopathy in pregnant women with type 1 diabetes compared with nonpregnant controls.

Canonical

clinical

Diabetic retinopathy in pregnancy

Alcon has completed its planned acquisition of LumiThera, Inc, which was announced in July of this year.

According to Alcon, the acquisition includes the noninvasive Valeda photobiomodulation (PBM) device for the treatment of early and intermediate 

dry age-related macular degeneration (AMD)

 and a subset of late dry AMD (non-central involving geographic atrophy).

Ian Bell, SVP and chief operating officer of Alcon, commented on the acquisition in a press release from the company, saying, “Since Alcon entered the retina space in 1997, we’ve focused our efforts mainly in surgical, delivering leading products and solutions for the operating room. As we welcome LumiThera and Valeda PBM to Alcon, we move into the retina clinic and the dry AMD space. We look forward to broadening access and availability to Valeda PBM so more dry AMD patients can benefit from early intervention.”

Alcon noted in a press release that Valeda PBM delivers nonphototoxic light therapy using 3 wavelengths that have demonstrated safety and efficacy in patients with dry AMD. It also noted data from the LIGHTSITE I, II, and III clinical trials that demonstrated visual acuity improvement with Valeda PBM without causing any discomfort in 97% of patients.

Data from the LIGHTSITE I, II, and III clinical trials conducted by LumiThera showed that PBM treatments provide visual acuity improvement with no treatment-related serious adverse events reported. The 

 was conducted at 10 sites across the US and evaluated 2 years of PBM treatment vs a control light therapy.

Results from the trial showed that patients with PBM-treated eyes gained 1 line of visual acuity (ETDRS) from baseline at months 13 and 21 and maintained it at month 24. Additionally, about 88% of patients in the PBM group maintained or gained vision vs baseline at month 24.

PBM uses low-level light to stimulate mitochondrial energy production, promoting retinal cellular health. It uses 3 specific, science-backed wavelengths to deliver nonphototoxic light therapy (not laser therapy). The noninvasive treatments are administered in a clinic setting.

Allen C. Ho, MD, FACS, FASRS, director of retina research at Wills Eye Hospital and chairman of the Alcon Research Institute (ARI) executive committee, said, “Treating dry AMD earlier—before the development of advanced disease—has always made sense, but we did not have technology that could improve vision until the introduction of Valeda PBM.”

Valeda PBM is currently available in the US and several countries in Europe and Latin America. Alcon notes that, pending regulatory approvals, it plans to expand Valeda PBM into additional markets, beginning in 2026.

Alcon announced it had acquired a majority interest in Aurion Biotech

 a clinical-stage company developing advanced cell therapies to treat eye diseases, and 

 The LENSAR acquisition includes the ALLY Robotic Cataract Laser Treatment System, LENSAR’s proprietary Streamline software technology, and the LENSAR legacy laser system. As noted, Alcon also completed its acquisition of LumiThera, Inc, and its PBM device for the treatment of early and intermediate dry age-related macular degeneration.

Most recently, Alcon entered into a definitive merger agreement with STAAR Surgical Company, through which Alcon intends to acquire STAAR. The planned acquisition of STAAR includes the EVO family of lenses (EVO ICL) for vision correction for patients with moderate to high myopia with or without astigmatism.

 EVO ICLs are implantable lenses that address a wide range of vision correction needs through a minimally invasive procedure that is reversible. EVO family ICLs are implanted between the iris and the natural crystalline lens during a procedure that does not remove corneal tissue.

All deals are expected to close in mid- to late-2025.

Alcon Completes Acquisition of LumiThera. Published September 3, 2025. Accessed September 5, 2025. 

https://www.alcon.com/media-release/alcon-completes-acquisition-lumithera/

Harp MD. Alcon to acquire LumiThera and its photobiomodulation device for the treatment of dry AMD. Published July 7, 2025. Accessed September 5, 2025. 

https://www.ophthalmologytimes.com/view/alcon-to-acquire-lumithera-and-its-photobiomodulation-device-for-the-treatment-of-dry-amd

Hutton D. LIGHTSITE III trial data demonstrates improvement in vision in intermediate dry AMD. Published June 23, 2022. Accessed September 5, 2025. 

https://www.ophthalmologytimes.com/view/lightsite-iii-trial-data-demonstrates-improvement-in-vision-in-intermediate-dry-amd

Harp MD. Alcon acquires majority interest in Aurion Biotech. 

. March 27, 2025. Accessed September 5, 2025. 

https://www.ophthalmologytimes.com/view/alcon-acquires-majority-interest-in-aurion-biotech

Harp MD. Alcon agrees to purchase LENSAR. 

. March 25, 2025. Accessed September 5, 2025. 

https://www.ophthalmologytimes.com/view/alcon-agrees-to-purchase-lensar

Harp MD. Alcon agrees to acquire STAAR Surgical. Published August 5, 2025. Accessed September 5, 2025. 

https://www.ophthalmologytimes.com/view/alcon-agrees-to-acquire-staar-surgical

The acquisition includes the noninvasive Valeda PBM device for the treatment of early and intermediate dry age-related macular degeneration.

Alcon completes acquisition of LumiThera

 showed that “inferred sensitivity” mapping may be a potential functional surrogate end point for 

 based on its ability to predict retinal function with high spatial resolution and without extensive psychophysical testing, according to Georg Ansari, MD, first author of the report published in 

Investigative Ophthalmology and Visual Science

. He is from the Institute of Molecular and Clinical Ophthalmology Basel and the Department of Ophthalmology, University Hospital Basel in Switzerland.

Currently, the treatments available for GA in the US—pegcetacoplan (Syfovre; Apellis Pharmaceuticals) and avacincaptad pegol (Izervay; Astellas Pharma US)—slow the disease progression. However, no treatment with a prospectively established functional treatment benefit is available.

“The challenge of selecting appropriate functional outcome measures for GA in treatment trials remains significant,” the researchers said.

Although the best-corrected visual acuity (BCVA), low-luminance VA, and dark adaptometry have been evaluated as functional metrics, they have failed “to effectively capture the progression of GA, primarily because GA may form in the parafovea, leading to foveal sparing. This phenomenon results in patients maintaining high VA despite having substantial parafoveal scotomas. Consequently, traditional measures such as the BCVA are insufficient for accurately assessing the functional impact of GA,"

Microperimetry addresses these limitations by evaluating retinal sensitivity across a broader area, including regions affected by foveal sparing.

 However, microperimetry is limited because of its sizable retest variability

Machine-learning and deep-learning algorithms have the potential to infer retinal function from spectral-domain optical coherence tomography (SD-OCT) images in a fully automated manner in non-neovascular and neovascular AMD,

 However, using these methods in clinical trials has been problematic because of the current lack of consensus. The authors theorized that incorporating patient-specific baseline data, such as microperimetry, could enhance the accuracy of inferred functional assessments in subsequent visits.

In the study under discussion, the investigators evaluated the effectiveness of different machine-learning models for predicting retinal sensitivity in GA secondary to 

 and compared the progression of sensitivity loss using observed vs inferred data over time.

A total of 30 patients (37 eyes) were included in the study, all of whom underwent microperimetry and SD-OCT imaging at baseline and weeks 12, 24, and 48. The retinal layers were segmented using a custom-written deep-learning algorithm.

The investigators used random forest, LASSO (Least Absolute Shrinkage and Selection Operator) regression, and multivariate adaptive regression splines, all machine-learning models, to predict the retinal sensitivity in 3 scenarios: unknown patients, known patients at later visits, and interpolation within visits. The study goals were the predictive accuracy and the models’ ability to reduce test variability over time, the investigators explained.

What were the results in machine-learning models?

Ansari and colleagues reported, “The random forest model demonstrated the highest accuracy across all scenarios, with mean absolute errors of 3.67 decibels (dB) for unknown patients, 2.96 dB for known patients at follow-up, and 3.10 dB for within-visit interpolation. The inferred sensitivity data significantly reduced the variability compared to the observed data in longitudinal mixed-model analysis, with a residual variance of 2.72 dB² vs 8.67 dB², respectively.”

“This inferred sensitivity mapping approach provides a spatially resolved, automated, and reproducible alternative to traditional psychophysical assessments, which are often limited by variability and practical constraints. Although prior studies have explored cross-sectional structure-function correlations in AMD, our analysis represents a systematic comparison in a longitudinal setting, demonstrating their capacity to track functional progression over time. The findings indicate that inferred sensitivity can serve as a robust functional surrogate end point, particularly for natural history studies where psychophysical testing may be impractical,” the authors commented.

Ansari and colleagues summarized, “Our study made it possible to use inferred sensitivity mapping as a potential functional surrogate end point for GA, demonstrating its capacity to predict retinal function with high spatial resolution and without the need for extensive psychophysical testing. In addition, our study demonstrates the superiority of SD-OCT-informed ‘interpolation’ over mere hill-of-vision interpolation. Future research should focus on validating this approach in larger, more diverse cohorts and exploring its integration into the design of clinical trials for retinal diseases.”

Ansari G, Schärer N, Pfau K, et al. Evaluating the progression of retinal sensitivity loss in geographic atrophy using machine-learning-based structure-function correlation (OMEGA 2). 

Heier JS, Lad EM, Holz FG, et al. Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials. 

Patel SS, Lally DR, Hsu J, et al. Avacincaptad pegol for geographic atrophy secondary to age-related macular degeneration: 18-month findings from the GATHER1 trial. 

Liao DS, Grossi FV, El Mehdi D, et al. Complement C3 inhibitor pegcetacoplan for geographic atrophy secondary to age-related macular degeneration: a randomized phase 2 trial. 

Sadda SR, Chakravarthy U, Birch DG, Staurenghi G, Henry EC, Brittain C. Clinical endpoints for the study of geographic atrophy secondary to age-related macular degeneration. 

Sunness JS, Rubin GS, Broman A, Applegate CA, Bressler NM, Hawkins BS. Low luminance visual dysfunction as a predictor of subsequent visual acuity loss from geographic atrophy in age-related macular degeneration. 

Pfau M, Lindner M, Steinberg JS, et al. Visual field indices and patterns of visual field deficits in mesopic and dark-adapted two-colour fundus-controlled perimetry in macular diseases. 

Pfau M, von der Emde L, Dysli C, et al. Determinants of cone and rod functions in geographic atrophy: AI-based structure-function correlation. 

Pfau M, Lindner M, Fleckenstein M, et al. Test-retest reliability of scotopic and mesopic fundus-controlled perimetry using a modified MAIA (macular integrity assessment) in normal eyes. 

Alibhai AY, Mehta N, Hickson-Curran S, et al. Test–retest variability of microperimetry in geographic atrophy. 

von der Emde L, Pfau M, Dysli C, et al. Artificial intelligence for morphology-based function prediction in neovascular age-related macular degeneration. 

Kihara Y, Heeren TFC, Lee CS, et al. Estimating retinal sensitivity using optical coherence tomography with deep-learning algorithms in macular telangiectasia type 2. 

Sumaroka A, Garafalo AV, Semenov EP, et al. Treatment potential for macular cone vision in Leber congenital amaurosis due to CEP290 or NPHP5 mutations: predictions from artificial intelligence. 

Müller PL, Odainic A, Treis T, et al. Inferred retinal sensitivity in recessive Stargardt disease using machine learning. 

Jayakar G, De Silva T, Cukras CA. Visual field sensitivity prediction using optical coherence tomography analysis in hydroxychloroquine toxicity. 

Recent research highlights inferred sensitivity mapping as a promising method to assess retinal function in geographic atrophy, enhancing clinical trial outcomes.

A study of the progression of sensitivity loss in GA over time using inferred data

Marion Munk Euretina 2025

Marion Munk, a medical retina and uveitis specialist from Switzerland, introduced the International Retinal Imaging Society (IntRIS), a unique organization that brought together retina specialists, ophthalmologists, PhDs, and biomedical engineers. The society was dedicated to advancing retinal imaging through collaborative efforts. 

Munk highlighted the IntRIS symposium at the 2025 EURETINA annual meeting, which is taking place in Paris, France. The symposium featured several distinguished speakers who presented groundbreaking research. Giovanni Staurenghi discussed color autofluorescence. Phil Rosenfeld explored the impact of ocular perfusion on geographic atrophy progression. Srinivas Sadda presented on metabolic activity in RPE cells using adaptive optics fluorescein lifetime imaging. The symposium also included an overview of recommendation guidelines for fibrosis, focusing on development, quantification, and appropriate imaging modalities. 

Munk emphasized the society's unique approach, which brought together diverse specialists to provide comprehensive perspectives on medical challenges. A key strength of IntRIS was its collaborative model. Biomedical engineers worked closely with physicians to develop clinically relevant imaging technologies. This approach ensured that new devices addressed real-world medical needs and had potential market viability. The interdisciplinary nature of the group allowed for innovative thinking and novel approaches to understanding retinal diseases. 

Munk stressed the importance of ultra-widefield imaging and its potential to transform clinical decision-making. She noted that imaging technologies must go hand-in-hand with drug development, providing robust methods to quantify and visualize conditions like non-perfusion and fibrosis. The conversation highlighted the challenges in current imaging technologies, particularly in differentiating between various types of retinal tissue. Munk argued that as drug therapies advance, more sophisticated imaging techniques would become crucial for precise diagnosis and treatment monitoring. The IntRIS symposium represented a forward-thinking approach to retinal imaging, combining clinical expertise, technological innovation, and collaborative research to push the boundaries of medical understanding and treatment.

The International Retinal Imaging Society (IntRIS) had a significant presence at this year's EURETINA Congress.

Videos

EURETINA 2025: Marion Munk, Md, PhD, discusses the IntRIS symposium

EURETINA 2025: Sofia Androudi on retinal disorders mimicking inherited retinal diseases

Note: The following transcript has been lightly edited for clarity.

 Good morning. My name is Sofia Androudi, and I'm professor and head of the University Eye Clinic in Thessaloniki, Greece. The topic of my talk today is retinal disorders mimicking inherited retinal diseases. Inherited retinal diseases is the most frequent cause of visual loss in people of working age. They affect 2.5 million of people globally, and as you can expect, they have a significant impact in quality of life and income loss. But the thing is that inherited retinal diseases patients get a diagnosis based on clinical phenotype alone, and we're talking about very heterogeneous disease. For instance, a retinitis pigmentosa can look like Leber congenital amaurosis. But on the other hand, there are retinal diseases, acquired diseases that can look like inherited retinal diseases. 

We're entering the era of cell and gene therapies, and it's very important to have a correct diagnosis, so the patient can get the appropriate treatment or does not get mistreated. To reach this diagnosis, you we need to have a high index of suspicion. We need to look at the unilateral versus bilateral. For example, if the disease is unilateral, we shift away from the IRD. We have to take a detailed medical and clinical history and ophthalmic history. For instance, when did the symptoms start? Are there any other family members affected? We have to take good quality multimodal imaging, and don't forget the electrophysiology. Where we are going from now with the artificial intelligence, the registries, and the advanced imaging, yes, we can refine our diagnostic algorithms, but at the end of the day, it's the multi-disciplinary approach and collaboration and the clinical hands that are our best tools.

Yes. So if you have a case that you are on the fence on, then you have to refresh and restart and think the case from the start. And don't forget to ask for help, ask other colleagues. You are a retina specialist, ask the uveitis specialist, get the genetic testing big and do perform high-quality, multi-modal imaging that you are going to look at yourself. Don't wait for the technician to bring you a print out, but go-to the machine, to the OCT and scroll frame-by-frame to look [for] what you're missing. And don't forget the autofluorescence.

Prof. Androudi said differential diagnoses are more important than ever in the era of cell and gene therapies.

Martin David Harp

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