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Moderator
Mariam Hamid, MD, ABO
Panelists
Jonathan B. Rubenstein, MD, ABO; Albert Y. Cheung, MD
Viewing Papers
Expand a paper title to the right to view the paper abstract and authors. Use the video link to jump to that poster in the session.
Presenting Author
Sujin Kang, MD
Co-Authors
Florence Cabot (MD), Angela Zhu (MD), Marco Ruggeri (PhD), Sonia Yoo (MD), David Tse (MD)
Purpose
To assess the feasibility, precision, and reproducibility of a novel robotic-assisted system designed for corneal transplantation, tested on synthetic corneal models in a laboratory setting. This study serves as an initial proof-of-concept prior to in-vivo trials.
Methods
A prototype robotic surgical platform, equipped with high-resolution stereoscopic visualization and microsurgical instrument manipulators, was adapted for corneal graft suturing. The Bioniko synthetic cornea models were used. Each procedure involved robotic suturing of a donor-mimicking graft using interrupted 10-0 nylon sutures.
Results
The robotic system successfully completed simulated corneal transplantations without device malfunction. Observations made were that with practice, surgical time decreased over successive trials, consistent with a learning curve. Graft-host apposition was graded as satisfactory. Further development in the robotic microsurgical instrumentation suited to ocular surgery would help to improve the current technique.
Conclusion
This preclinical laboratory trial demonstrates that robotic-assisted corneal transplantation on synthetic models is technically feasible, with high accuracy and suture placement reproducibility. This approach has potential to enhance surgical precision and ergonomics. The device is not yet FDA-approved, and results are limited to artificial models.
Presenting Author
Antonio Di Zazzo, MD
Co-Authors
Rita Mencucci (MD), Marta Sacchetti (MD), Luigi Fontana (MD), Alessandro Lambiase (MD, PhD), Edoardo Villani (MD)
Purpose
Atopic keratoconjunctivitis (AKC) is a chronic, immune-mediated ocular surface disease that may severely impair visual function and quality of life. This study assessed the effects of DFL24498, a dual inhibitor of TRPML2 (mast cell activation mediator) and calcineurin (adaptive immune regulator), ophthalmic solution at 2 dosages in adults with AKC.
Methods
In this phase II, multicenter, randomized, double-masked, vehicle controlled, dose-ranging clinical trial, adult patients diagnosed with AKC were recruited. Enrolled patients were randomized 1:1:1 into a 4-week treatment of either DFL24498 2x/day (BID), 4x/day (QID), or vehicle QID and followed up for an additional 2 weeks. The primary endpoint was change from baseline (BL) to Week 4 (W4) in ocular itching measured by a visual analogue scale. Secondary endpoints included ocular symptoms score and signs composite score changes from BL to W4. ANCOVA was conducted for each treatment arm versus vehicle, using a one-sided ?=0.0125. Adverse events were monitored throughout the study.
Results
Sixty-nine patients (mean age: 40.4 years; 55.1% male) received DFL24498 BID (n=22), DFL24498 QID (n=23), or vehicle (n=24). DFL24498 QID significantly reduced ocular itching (-32.9 ± 5.78 [SE]) versus vehicle (-10.0 ± 5.76 [SE], p=0.003). The DFL24498 QID arm also showed significant reductions when compared to vehicle in composite symptoms scores?(-3.0 ± 0.64 [SE] vs. -0.5 ± 0.64 [SE], respectively, p=0.002) and composite signs scores (-2.1 ± 0.48 [SE] vs. -0.3 ± 0.48 [SE], respectively, p=0.003). There were no significant differences between the DFL24498 BID arm versus vehicle for these endpoints. No serious adverse events were reported, and treatment was well tolerated.
Conclusion
This is the first clinical trial to evaluate novel compound, DFL24498 ophthalmic solution in AKC.?These results demonstrated safety and efficacy of DFL24498 QID in adults with AKC and support further clinical development.
Presenting Author
Gabriela Rodriguez, BSc, MS
Co-Authors
Corinne Rabbin-Birnbaum (BA), Gerald Zaidman (MD), Christopher Davey (BA)
Purpose
Megalocornea, characterized by abnormally large corneas, can present as an isolated finding or part of broader syndromes. X-linked megalocornea (XMC) is linked to mutations in CHRDL1, a gene encoding ventroptin. This report describes two brothers with the same rare CHRDL1 mutation and compares findings with prior studies.
Methods
We conducted a case report of two male siblings presenting with XMC. Genetic testing was performed to identify CHRDL1 variants, and findings were compared with previously reported cases in the literature, with particular attention to genotype-phenotype correlations.
Results
Both brothers were found to carry the c.464G>A p. (Cys155Tyr) missense mutation in CHRDL1. This mutation, previously described in a single proband, was here identified in two siblings, representing the first report of affected brothers with this genetic variant. Their unaffected mother was identified as a heterozygous carrier of the gene. Review of prior studies highlights variability in clinical manifestations among individuals with CHRDL1 mutations.
Conclusion
This report expands the phenotypic and genetic understanding of XMC, documenting the first sibling pair with the c.464G>A mutation in CHRDL1. Early genetic screening can aid in family counseling, and further research is needed to clarify genotype-phenotype relationships.
Presenting Author
David L Wirta, MD
Co-Authors
Karolinne Rocha (MD, PhD), Laura Bailey (PhD), Kari Basso (PhD), Jenny Jones (PhD), Michelle Senchyna (PhD), Mark Milner (MD)
Purpose
In Ph3 clinical studies, acoltremon 0.003% (ACO, TRYPTYR®), a first in class topical ocular neuromodulator, led to rapid and consistent increased tear production in a high proportion of subjects, as measured by unanesthetized Schirmer test (UST), as early as Day 1. This Ph3b study aimed to further characterize the tear response stimulated by ACO.
Methods
Single-center, open-label, single-arm, acute dosing study involving 41 adults with dry eye disease (DED) based on specific signs and symptoms. Qualified subjects underwent baseline optical coherence topography (OCT) imaging of the central tear meniscus (TM) in the left eye and had baseline basal tears collected from the right eye. OCT-TM imaging and tear collection were repeated 3 minutes post-dosing of 1 drop of ACO in each eye. Tear samples were analyzed for total lipid concentration (TLC). Mean change from baseline (CFB) in OCT-TM height (TMH) and OCT-TM area (OCT-TMA) were analyzed using paired t-test, and CFB in TLC was analyzed for superiority using paired t-test of geometric means.
Results
ACO led to a statistically significant increase in OCT-TMH (mean CFB: 504 ± 560 um; 90% confidence interval [CI]: 357, 651; P<0.0001) and OCT-TMA (mean CFB: 166253 ± 257763 um2; 90% CI: 98468, 234037; P<0.0001). Of the 41 subjects, 34 provided sufficient tear samples for TLC analysis. The geometric mean TLC post-ACO was 221 ± 2.4 ng/uL which was statistically significantly greater (P=0.0143) than the TLC in subject's baseline basal tears collected pre-ACO (128 ± 4.3 ng/uL). The geometric mean ratio of post- to pre-ACO TLC equated to 1.72 (90% CI: 1.15, 2.58). The only adverse event was instillation site irritation, reported in 39% of subjects, all of whom rated the sensation as mild.
Conclusion
Consistent with Ph3 UST data, ACO led to a significant increase in tear volume. Furthermore, a significantly greater total lipid concentration was found in ACO-stimulated tears. Given the critical role of lipids in the tear film, the observation that ACO increases natural lipid secretion further supports the potential of ACO as a treatment for DED.
Presenting Author
Emine Esra Karaca, MD
Co-Authors
Ozlem Evren Kemer (MD), Ali Seydi Keçeli (PhD), Ayd?n Kaya (PhD), Fatih ?en (BA), Alaettin Uçan (PhD), Hamdi Yal?n Yal?ç (PhD), Alpaslan Mete Karaca (MSc), Ayça Bulut Ustael (MD), Dilara Altun (MD), Ali Ya?ar Yi?it (BSc), Feyza Dicle I??k (MD), Adem Ali Y?lmaz (BSc)
Purpose
To assess graft health or potential failure after Descemet membrane endothelial keratoplasty (DMEK) using a deep learning classifier from anterior segment optical coherence tomography (AS-OCT) images, and to report its performance. Previous studies suggest AS-OCT and AI are promising for predicting DMEK outcomes.
Methods
A single-center labeled dataset was curated to train the deep learning model. In total, 7,814 AS-OCT images from 65 patients were analyzed. Of these, 7,640 images (5,187 healthy, 2,453 unhealthy) were used for training, 1,536 images (1,058 healthy, 478 unhealthy) for validation, and 1,500 images (1,000 healthy, 500 unhealthy) for testing. An EfficientNet-B5 classifier was fine-tuned. On the test set, class-wise precision, recall, F1-score, and overall accuracy were computed.
Results
On the test set (n=1,500), overall accuracy was 95%. In the class representing healthy grafts (n=1,000), precision was 0.96, recall 0.97, and F1-score 0.96; in the class representing graft failure (unhealthy; n=500), precision was 0.93, recall 0.93, and F1-score 0.93. Macro-averaged precision, recall, and F1-score were each 0.95. Despite an approximately 2:1 class imbalance, the model demonstrated high and balanced discriminative performance across both classes and accurately distinguished healthy from failure-prone grafts.
Conclusion
The AS-OCT-based deep learning model distinguishes healthy from failing grafts after DMEK with 95% accuracy. It provides an effective tool for early detection and timely clinical intervention. Larger clinical trials are required to validate its effectiveness in routine practice and integration into ophthalmic workflows for better graft monitoring.
Presenting Author
Arun C. Gulani, MD
Co-Authors
Aaishwariya Gulani (MD)
Purpose
To evaluate the clinical outcomes of LaZrPlastique, an innovative refractive surgery system designed to correct corneal scars and irregular corneas directly to functional vision, reducing reliance on invasive corneal transplantation.
Methods
This retrospective study reviewed 73 eyes of 60 patients (55% female, 45% male) treated with LaZrPlastique over 18 years. The system integrates special-purpose laser nomograms, custom-designed instruments, and structured training protocols. Preoperative and postoperative visual acuity (Vsc) was analyzed using Snellen and LogMAR equivalents. Etiologies of scarring included infectious keratitis, corneal dystrophies, and Irregular and Scarred Corneas following refractive surgery complications. Patient satisfaction was assessed postoperatively.
Results
All patients demonstrated visual improvement following surgery. Mean preoperative Vsc improved from 0.77 to 0.06 LogMAR (approximately 20/200 to 20/22 Snellen equivalent). Functional recovery was rapid, with minimal tissue disruption and no patient needed any kind of corneal transplants. Representative cases included severe infectious scars and irregular astigmatism following surgical complications, each achieving unaided vision restoration. Overall, 100% of patients reported postoperative satisfaction, with significant reduction in visual disability and return to productivity.
Conclusion
LaZrPlastique represents a paradigm shift in the management of corneal scars and irregular corneas, offering a refractive-based, tissue-preserving alternative to transplantation aspiring for unaided vision outcomes. Refractive and cataract surgeons worldwide can therewith manage Irregular corneas and restore patients to functional unaided vision.
Presenting Author
Andrea Naranjo, MD
Co-Authors
Sarah Abdelrahman (MPH), Jameson Clover (BSc), Jennifer RoseNussbaumer (MD)
Purpose
To compare tissue loss while processing corneal grafts for standard Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) and Descemet's membrane endothelial keratoplasty (DMEK).
Methods
Retrospective observational study of all endothelial corneal grafts processed from January 2019 through December 2023 at VisionGift Eye Bank in Portland. Classification for DSAEK grafts was based on target thickness, ?80 µm for UT-DSAEK and 80-130µm for DSAEK. Tissue imported from other eye banks and those with no reported target depth were excluded. DSAEK grafts were attempted to target thickness using a microkeratome. DMEK grafts were pre-peeled using the SCUBA technique.
Results
A total of 61/1254 (5%) of the standard DSAEK tissue, 75/722 (10%) UT-DSAEK tissue and 119/3820 (3%) of the DMEK tissue was deemed unsuitable for transplantation(p<0.001). The most common cause for failure in both DSAEK and UT-DSAEK groups was endothelial dropout (44% and 36%, respectively) and tears (52%) in the DMEK group. Decrease in target thickness and deviation from target was associated with higher failure rates in both DSAEK and UT-DSAEK groups (p<0.001). Higher Diabetes Mellitus severity and pseudophakia were associated with increased failure risk in the DMEK group (p<0.001).
Conclusion
In this study, UT-DSAEK tissue loss was 3 times higher compared with DMEK. Eye banks are being challenged by the trend to request thinner DSAEK tissue and surgeons should be mindful of the impact of their surgical preferences.
Presenting Author
Emine Esra Karaca, MD
Co-Authors
Kas?m Öztoprak (PhD), Feyza Isik (MD), Ozlem Evren Kemer (MD), Ayça Bulut Ustael (MD)
Purpose
To develop and validate a novel benchmarking model for Descemet Membrane Endothelial Keratoplasty (DMEK) that integrates patient character- istics, donor tissue factors, surgical variables, and center-specific parameters to provide individualized risk assessment and outcome prediction.
Methods
Based on a comprehensive literature review, we developed the DMEK Risk and Outcome Prediction (DROP) Score model, comprising four component subscores: Patient Risk Profile (PRP), Donor Tissue Quality (DTQ), Surgical Com- plexity Index (SCI), and Center Performance Factor (CPF). These subscores are weighted and combined into a composite risk score that predicts multiple outcomes including graft survival, visual acuity, endothelial cell loss, and complication risks. The model was implemented in Python and validated using a synthetic dataset of 500 patients based on distributions and associations reported in the literature.
Results
The DROP Score model demonstrated good discrimination for binary outcomes (AUC: 0.782 for graft failure at 1 year, 0.763 for rebubbling, 0.741 for rejection) and moderate to strong correlations between predicted and observed values for continuous outcomes (r: 0.684 for BCVA at 12 months, 0.712 for ECL at 12 months). The model effectively stratified patients into four risk categories with clear separation of outcomes across categories. Sensitivity analysis revealed the relative importance of individual variables, and Monte Carlo simulation quantified uncertainty in the model predictions.
Conclusion
The DROP Score represents a significant advancement in bench- marking for DMEK surgery, providing a comprehensive framework for individual- ized risk assessment and outcome prediction. The model has potential applications in preoperative planning, informed consent, risk-adjusted outcome reporting, sur- gical decision-making, and patient selection.
Presenting Author
Kimia Rezaei, BSc
Co-Authors
Joshua Ong (MD), Rupesh Agrawal (MS), Nathan Vu Pham (BSc), Marina Zakhary Gad El Sayed (BSc), Ibrahim Abboud (BSc), Jainam Shah (BSc)
Purpose
To evaluate the incidence and relative risk of amblyopia (deprivation, refractive, or strabismic type) following uveitis, compared with a matched non-uveitic control cohort, using the TriNetX global research network.
Methods
Retrospective matched cohort study using deidentified electronic health record data from the US Collaborative Network within TriNetX (67 organizations). Pediatric patients aged ?18 years with uveitis (January 1, 2005-August 10, 2025) were included; the index event was the first qualifying diagnosis. Patients with viral hepatitis, HIV, diabetes, tuberculosis, or congenital cataract were excluded. Matching used demographics, autoimmune/ocular comorbidities, and inflammatory markers. Incident amblyopia (deprivation, refractive, strabismic) at 3, 6, 12, 24, and 60 months; prior amblyopia excluded. Cox models estimated hazard ratios (95% CI).
Results
A total of 20,905 uveitis patients and 344,170 controls were identified; after matching, 20,630 remained in each group. At 3 months, the incidence of deprivation amblyopia was 0.37% vs 0.15% (RR 2.47; p < 0.0001). At 6 months, 0.48% vs 0.18% (RR 2.69; p<0.0001); 1 year, 0.63% vs 0.20% (RR 3.19; p<0.0001); 2 years, 0.79% vs 0.24% (RR 3.32; p<0.0001); 5 years, 1.02% vs 0.25% (HR 4.14; p<0.0001). Overall, uveitis conferred a greater than 4-fold risk of deprivation amblyopia (HR 4.65; 95% CI 4.06-5.32; p < 0.0001). Refractive and strabismic amblyopia were consistently higher in the control group at all intervals.
Conclusion
In this large, multicenter analysis, uveitis was associated with a progressively higher risk of deprivation amblyopia, with an overall fourfold increased hazard compared to controls. Findings highlight the importance of early vision monitoring and timely intervention to prevent irreversible loss
Presenting Author
Samaresh Srivastava, MD
Co-Authors
Asav Patel (MD), Shail Vasavada (DNB, FRCS), Abhay Vasavada (MS, FRCS), Lajja Shastri (MS), Vandana Nath (MS, DO)
Purpose
To evaluate the incidence and subtype distribution of Dry Eye Disease (DED) using a dedicated Ocular Surface Analyzer, with classification based on clinical parameters aligned with the Asia Dry Eye Society (ADES) and TFOS DEWS II criteria.
Methods
A prospective observational study was conducted on 150 symptomatic patients presenting between January and June 2025. Comprehensive ocular surface evaluation was performed using the IDRA (Essilor) platform, assessing non-invasive tear film break-up time (NIBUT), lipid layer thickness, tear meniscus height (TMH), blink quality, and meibomian gland imaging. Schirmer's test and Dry Eye Questionnaire were administered for every patient. Dry eye was classified into evaporative dry eye (EDE), aqueous deficiency dry eye (ADDE), or mixed type, based on ADES simplified criteria and TFOS DEWS II framework. Demographics, clinical history, and screen time exposure were recorded.
Results
Among 150 patients (mean age 46.59 ± 16.71 years, 55% female), 80% (n=120) had EDE, 16% (n=24) had ADDE, and 4% (n=6) had mixed type. EDE was associated with prolonged screen time (p<0.05), while ADDE correlated with older age (p<0.01). IDRA Analysis showed reduced lipid layer thickness in 80% of EDE cases, and diminished TMH in 16% of ADDE cases.
Conclusion
IDRA surface analyzer provides robust, non-invasive diagnosis and subtype DED, identifying EDE as the predominant subtype. High prevalence of EDE, particularly among younger patients with prolonged screen exposure, highlights evolving DED patterns. Integrating IDRA findings with ADES and TFOS DEWS II guidelines supports management strategies.
Presenting Author
Jaron Sanchez, DO
Co-Authors
Mohammad Soleimani (MD)
Purpose
This study aims to investigate the role of anterior segment optical coherence tomography angiography (AS-OCTA) in determining the prognosis of ocular chemical injuries by correlating angiographic features with early complications and visual outcomes.
Methods
Forty-six eyes of 36 patients with acute chemical injuries at Farabi Eye Hospital were studied prospectively. Participants received immediate medical care, followed by thorough ophthalmological examinations, including slit-lamp examination and AS-OCTA imaging. Angiographic parameters were analyzed for both superficial and deep layers of the ocular surface microcirculation in nasal and temporal quadrants.
Results
The study found that increases in deep and superficial vessel diameter indices (VDI) are associated with higher risk of corneal melting and keratitis, respectively, while a decrease in deep VDI is associated with a significantly higher risk of conjunctivalisation. Decreased superficial vessel length density (VLD) and limbal superficial vessel density (VD) are associated with higher risks of corneal opacification. Additionally, limbal ischemia was found to be significantly correlated with longer healing times.
Conclusion
AS-OCTA shows potential as a prognostic tool in ocular chemical injuries. Considering the early changes in angiographic parameters, we can predict specific post-chemical-burn complications.
Presenting Author
Iskender A Solmaz, MD
Co-Authors
Patrick Rochette (PhD), Isilay Kavadarli (MD), Canan Gur (PhD), Oguz Kul (PhD)
Purpose
Corneal endothelial cell (CEC) telomeres are the shortest among ocular tissues. Short telomeres can lead to cell senescence and death. We hypothesized that preventing telomere attrition in Fuchs endothelial corneal dystrophy (FECD) cells will prevent CEC loss.
Methods
The left eyes of eight 16-month-old New Zealand rabbits were treated with TAED017 (cycloastragenol-based formulation) for six months, while the untreated right eyes served as controls. 0.05 mL of TAED017 was applied twice daily to the left eye. Endothelial cell density was measured using specular microscopy (NIDEK-CEM 530, Japan) and reported as a percentage of baseline values. Corneal tissue cryosections (5 µm) were labelled with telomere peptide nucleic acid fluorescence in situ hybridization (PNA-FISH) probes, and nuclei were counterstained with Hoechst. Telomere length in corneal layers was quantified as the ratio of telomere to nuclear signal intensity normalized to untreated controls.
Results
CEC density was measured in untreated and treated eyes at baseline and after six months, showing a 9.5% higher density in treated eyes. TAED017 treatment maintained longer CEC telomere lengths compared to untreated eyes after six months.
Conclusion
TAED017 treatment prevents corneal endothelial cell loss, suggesting it may serve as a potential therapy for FECD, preserving CECs in early-stage patients and reducing the need for invasive procedures.
Presenting Author
Stuti Chamola, MS
Co-Authors
Rohit Shetty (FRCS), Abhijit ROY (PhD), Apeksha Kataria (DNB), Rahul Patil (MSc)
Purpose
To quantify tear film thickness (TFT) in early keratoconus (KC) and healthy eyes and correlate with tear biomarkers.
Methods
Prospective, case-control, single-centre study of 100 eyes which were included and grouped into early KC (n=50) and healthy eyes (n=50). Imaging was with Pentacam OCT, a Scheimpflug based ultra-high resolution, widefield OCT with axial resolution of ~1.4µm and scan diameter of 12mm. Custom edge detection and segmentation software were developed to calculate TFT. 25 radial OCT B-scans were also acquired. Additionally, tear samples were analysed for 8 biomarkers. AI predicted scores were derived from these biomarkers.
Results
In central 5 mm zone of imaging, the mean TFT was found to be 3.09 (KC) and 3.16 µm(healthy). As zone size increased, mean TFT decreased in KC patients (p<0.05). It was also found that all biomarkers were elevated in KC eyes. MMP-9 strongly correlated with the AI predicted score (Spearman correlation coefficient r = 0.684, P = 0.0291) in KC.
Conclusion
A new Scheimpflug based optical imaging technique can be used to quantify TFT and correlate with incidence of ocular inflammation. Using AI models, one could support treatment of patient symptoms in healthy and KC eyes.
Presenting Author
Rohan Mehra, MBBS, MS
Co-Authors
Pooja Mehta (MBBS, MS), Himanshu Mehta (MBBS, MS)
Purpose
The sharp spike in digital screen time in all age groups has led to deterioration of the ocular surface. The aim of the study is to assess the impact of the Covid lockdown on ocular surface health over a period of 5 years.
Methods
3523 patients of age ranging from 19 to 68 were divided in 4 groups based on age. Assessment of OSDI Score for severity of symptoms, TBUT and Schirmmers for severity of signs and meibography to assess gland drop outs was done over a 5 year period with periodic follow ups 3 monthly. All examinations were done by a single ophthalmologist to remove any bias.
Results
There was an increase in the OSDI score across the groups clearly showing the worsening of symptoms. The TBUT did not proportionately correspond to the changes in Schirmmers which was a major finding and the meibography showed marked increase in gland drop out areas across all groups.
Conclusion
The Covid pandemic has impacted our lives across all spheres and ocular surface health has not been spared either, but the magnitude of the impact needs to be reported and our study is one of the largest to report long term effects of increased screen time showing positive correlation, thus demanding corrective measures be taken.
Presenting Author
Sam Garg, MD
Co-Authors
Emmanuel Cabrera (MD), Christina Fleming (BSc), Roger Goldberg (MD, MBA), Jeffrey Goldberg (MD, PhD), Valeria Sanchez Huerta (MD, FACS)
Purpose
Corneal endothelial cell (CEC) therapy can improve vision in patients with corneal edema, but the importance of Rho kinase inhibition and safety of repeat injection are unknown. Here we evaluated the safety and efficacy of a repeat dose of magnetic human CEC (EO2002) with or without topical Ripasudil in subjects with symptomatic corneal edema.
Methods
This prospective, single-center, open-label study enrolled subjects with corneal edema. Two cohorts each received a 500K cell injection on Day 0 and a second 500K cell injection 6 weeks later; Cohort 2 were also treated with topical ripasudil QID from day 0 through week 19. All subjects were followed for 32 weeks (6 months after the second EO2002 injection) for safety, and for efficacy measures of best corrected visual acuity (BCVA) by ETDRS, and central corneal thickness (CCT) by ultrasound pachymetry and anterior segment optical coherence tomography (AS-OCT). (NCT: 05636579)
Results
Eleven subjects with baseline vision ? 20/40 received an intracameral injection of EO2002. Of those, ten received a second dose 6 weeks later. No SAEs occurred. All TEAEs were mild/moderate, resolving or clinically stable by the last visit. There was no notable increase in frequency or severity of TEAEs after re-injection. In the per-protocol set, 50% of subjects gained ?10 letters and 38% gained ?15 letters at week 32. Mean BCVA change was +7.0 letters at week 6 and +8.4 letters at week 32. There was no difference in BCVA between groups, indicating Ripasudil had no treatment effect on BCVA improvement. CCT decreased in both cohorts, with greater reduction in the Ripasudil group.
Conclusion
Magnetic CEC therapy is safe to re-inject at 6 weeks. Daily use of topical Ripasudil did not improve visual outcomes compared to EO2002 cell therapy alone, but it did further reduce central corneal thickness. These data support magnetic cell delivery as a repeatable, non-surgical alternative to keratoplasty, not dependent on Rho kinase inhibitions.
