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Moderator
Winston D Chamberlain, MD, PhD, ABO
Panelists
Alice T. Epitropoulos, MD, FACS, ABO; Eric Weinlander, MD, FACS, ABO
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
Cathleen M. McCabe, MD
Purpose
Dry eye syndrome (DES) causes chronic discomfort and visual disturbance. Lutein/zeaxanthin, curcumin, and vitamin D3 (LCD) are anti-inflammatory ocular surface protectants that, when taken as an oral supplement, improve DES symptoms and reduce inflammation. This analysis compares LCD efficacy and safety from an Indian and a larger US study.
Methods
These 2 double-blind, placebo-controlled, 8-week studies randomized patients 1:1 to receive either LCD or placebo (PBO) soft gels to be taken with breakfast. The Indian study was conducted at a single site compared with the multicenter US study. The primary efficacy outcomes were change in tear volume (Schirmer’s test) and symptom severity (Ocular Surface Disease Index [OSDI] score) on days 14, 28, and 56. Secondary endpoints included tear film breakup time (TBUT), tear osmolarity, symptom progression (standard patient evaluation of eye dryness [SPEED] score), ocular surface disease (corneal/conjunctival staining), and inflammation (tear film presence of MMP-9) at each timepoint.
Results
In both studies (US: N=116; India: N=59), change from baseline in the LCD group was significantly improved vs PBO in tear volume (Schirmer’s test; days 28 and 56; P<0.05) and symptom severity (OSDI score; days 14, 28, and 56; P<0.05). The US study found no between-group differences in artificial tear (AT) use, but the Indian study saw reduced AT use with time in the LCD group. Both studies, however, showed significant reductions in ocular inflammation (tear film matrix metalloprotease-9 [MMP-9] positivity) at day 56 (P<0.05).
Conclusion
Both studies show that, vs PBO, 8 weeks of daily LCD improves factors key to positive ocular surgery outcomes: tear volume and dry eye symptoms. Additionally, LCD significantly reduced ocular inflammation at 8 weeks. In both daily eye care and pre- and postsurgical protocols, LCD may provide clinically meaningful benefits to dry eye sufferers.
Presenting Author
Eric D. Donnenfeld, MD
Purpose
Lifitegrast ophthalmic solution, 5.0% is an anti-inflammatory agent indicated for the treatment of signs and symptoms of dry eye disease. This post hoc analysis of phase 3 pivotal data identified patients with rapid and pronounced reduction in dry eye symptoms with lifitegrast treatment and evaluated defining characteristics.
Methods
This was an exploratory analysis of data from the OPUS-2 and OPUS-3 studies (NCT01743729, NCT02284516): 12-week, prospective, double-masked, multicenter, placebo-controlled, randomized, parallel-arm clinical trials. Pooled data in the lifitegrast treatment arm were analyzed using a cluster analysis to identify homogenous populations of patient response types based on percent change from baseline in eye dryness score (EDS; as evaluated on a VAS 0-100 scale) at Days 14, 42, and 84. Patients with Sjögren’s syndrome or incomplete data were excluded from the analysis. Patient demographics and baseline characteristics among the defined subgroups were evaluated.
Results
Five patient subgroups were identified in the lifitegrast treatment arm: early sustained responders with ≥60% EDS reduction at all time points (n=113; 17.7%); steady responders with ≥20%, ≥40%, and ≥60% reduction at Days 14, 42, and 85 (n=113; 17.7%); Day 84 response of ≥60% (n=127; 19.9%); Day 84 response of ≤30% to <60% (n=119; 18.7%); Day 84 response of <30% (n=166; 26.0%). There were significant differences in mean symptom scores across the 5 patient subgroups (P<0.001), with numerically lower mean symptom scores for eye pain, burning/stinging, foreign body sensation, and photophobia in the patients demonstrating an early sustained response.
Conclusion
The majority of patients treated with lifitegrast had ≥60% reduction in EDS by Day 84. The group with rapid and sustained EDS reductions by week 2 tended to have lower symptom scores than the other subgroups, suggesting that early treatment may be beneficial for maximal response. Further studies to corroborate these findings are warranted.
Presenting Author
Lisa K. Feulner, MD, PhD
Purpose
Lifitegrast ophthalmic solution 5% is indicated for treatment of signs and symptoms of dry eye disease (DED). Lifitegrast demonstrated symptom relief starting at 2 weeks and a favorable safety profile in clinical trials. We report findings from 2 real-world evidence studies, a provider survey and a pharmacovigilance (PV) database analysis.
Methods
Eyecare providers (ECPs: ophthalmologists and optometrists) completed a survey and submitted case reports on patients treated with lifitegrast. Twelve ECPs treated an average of 1288 patients with DED annually, with 21% of these patients, on average, receiving lifitegrast. Seven ECPs provided 36 case reports of patients (mean age, 51 years; mean number of follow-up visits, 5) with aqueous-deficient (39%), evaporative (14%), or mixed (47%) DED. Postmarketing safety data from approval in the United States (July 2016) to July 10, 2024, were reviewed using a company PV database with reports from providers and patients.
Results
In the survey, two-thirds (67%) of ECPs reported near/complete symptom resolution in patients after 1-3 months of lifitegrast treatment. Case report data indicated that improvement was sustained throughout treatment, with a mean duration of 29 months (range, 1-69). Adverse events (AEs) considered by the ECPs as related to lifitegrast use included blurred vision, burning/stinging, and dysgeusia; all were mild or moderate in severity. In the postmarketing database, cumulative patient exposure with 8 years of worldwide use was estimated at 915,260 patient treatment-years. No new safety signals were identified.
Conclusion
Results from the ECP survey show that treatment with lifitegrast provides sustained symptom relief in patients with DED, and the AEs reported were consistent with the known safety profile of lifitegrast. Long-term use revealed no new or changing safety signals during routine safety monitoring.
Presenting Author
Zeynep Soysarac Nergizal, MD
Co-Authors
Leyla Asena (MD), Sibel Oto (MD, FACS), Dilek Dursun Altinors (MD, FACS)
Purpose
To evaluate the efficacy of topical losartan eye drops in reducing corneal haze of various etiologies, including post-photorefractive keratectomy (PRK), post-corneal cross-linking (CXL), post-infectious keratitis, and corneal dystrophies.
Methods
A prospective study including 14 eyes of 12 patients (aged 7-78 years; F/M: 4/10) with clinically significant corneal haze was conducted. All patients received topical losartan eye drops (0.8 mg/ml, 6 times daily) for a period of 3 to 9 months. Baseline and follow-up assessments included best-corrected visual acuity (BCVA), slit-lamp haze evaluation independently performed by two cornea specialists, corneal topography, and corneal densitometry. Anterior segment images were obtained, and corneal haze areas were quantified in square milimeters using image-analysis software. Wilcoxon signed ranks test was performed to compare pre-and post-treatment values.
Results
Snellen BCVA improved from 0.51±0.28 to 0.64±0.34 (p=0.01). Mean central corneal thickness and corneal volume remained stable (459.7 to 460 µm, p=0.53; 57.95 to 57.53 mm�, p=0.67). Structural indices including ISV (Index of Surface Variance) and IHA (Index of Height Asymmetry) were stable (60.5 to 62.9, p=0.43; 22.9 to 24.4, p=0.55). Corneal densitometry decreased from 28.23 to 26.34, indicating reduced haze intensity, although not statistically significant (p=0.42). Haze area reduced significantly (17,301.9 mm� to 11,164.8 mm�, p=0.002). Slit-lamp assessment showed improved haze and increased clarity in 10/14 eyes, stability in 4/14, with no worsening or treatment-related adverse effects.
Conclusion
Topical losartan eye drops demonstrated a favorable safety profile and showed promising efficacy in reducing corneal haze across different etiologies. These preliminary findings suggest that losartan may represent a novel antifibrotic treatment option for corneal fibrosis.
Presenting Author
Soham J Barot, None
Co-Authors
Alice Epitropoulos (MD, FACS)
Purpose
To evaluate real-world treatment patterns and clinical outcomes with cyclosporine 0.1% in semifluorinated alkane, focusing on symptom relief, corneal staining, and visual acuity in patients with dry eye disease.
Methods
This retrospective real-world evidence observational study analyzed electronic medical records of patients with dry eye disease treated with cyclosporine 0.1% in semifluorinated alkane for 6 months. Symptoms were assessed using the SPEED questionnaire. Corneal staining was graded using the Oxford grading scale (0-5). This study included patients with staining score ranging from 0 to 3; no patients presented with grades 4 or 5. Best-corrected visual acuity (VA) was compared before and after treatment. Qualitative symptom descriptions were collected for a subset of patients and all outcomes were compared from baseline to most recent follow-up.
Results
A total of 58 patients were included in the analysis. Patient-reported symptoms improved significantly (p < 0.001), with the mean SPEED score decreasing from 12.45 at baseline to 8.03 at the most recent follow-up (35.5% decrease). Objective clinical signs of corneal staining using the Oxford Grading System also showed a statistically significant reduction. In the right eye (OD), the mean staining score decreased from 1.11 to 0.47, (57.7% decrease) (p < 0.001). In the left eye (OS), the mean score decreased from 1.11 to 0.55, (50.5% decrease) (p < 0.001).
Conclusion
Treatment with cyclosporine 0.1% in semifluorinated alkane demonstrated a statistically significant improvement in both patient-reported symptoms and objective clinical signs of dry eye disease in this real-world patient cohort.
Presenting Author
Rom Kandavel, MD
Purpose
We report on a prospective study using validated, patient-driven questionnaires (e.g. OSDI questionnaire) to provide critical insight into both the rapidity of symptom relief and specific symptom characterization to help in future clinical application of TRYPTYR dry eye medication for moderate to severe dry eye patients.
Methods
50 patients ages 18 and older with moderate to severe dry eye as scored with the Ocular Surface Disease Index (OSDI) will be enrolled and started on TRYPTYR eye drops OU BID. Patients with previous corneal disease or surgery, glaucoma, and Sjogren's will be excluded. OSDI surveys will be collected at baseline,treatment at 14 days, and at 28 days. Secondary endpoints include change from baseline rating scale 1-5 in severity of symptoms of Blurriness, eye irritation/Discomfort, Burning/Stinging, Photophobia/Pain, Sandy/gritty/Foreign Body Sensation, Fatigue/Tired Eyes). Patients will also report 1st dose at which any improvement is noted subjectively.
Results
TBD
Conclusion
TBD
Presenting Author
Ryan S. Huang, MD, MSc
Co-Authors
Andrew Mihalache (None), Marko Popovic (MD), Clara Chan (MD, FRCSC)
Purpose
To systematically evaluate and compare the efficacy of topical pharmacologic therapies in the management of subepithelial infiltrates (SEIs) following epidemic keratoconjunctivitis (EKC).
Methods
This systematic review was conducted in accordance with PRISMA guidelines and prospectively registered with PROSPERO. PubMed (MEDLINE), Ovid Embase, and the Cochrane Library were searched from inception to September 1, 2025, for randomized controlled trials and observational studies evaluating topical treatments for SEIs following EKC. The primary outcomes for meta-analysis were complete SEI resolution and recurrence rates. Secondary outcomes included changes in best-corrected visual acuity (BCVA). Meta-analyses were performed using a random-effects generalized linear mixed model. A P-value of <0.05 was considered statistically significant.
Results
Fourteen studies comprising 597 eyes of 513 patients were included. At the last study visit, the pooled SEI resolution rate was 69.5% (95%CI=37.3%-89.7%, I�=80.7%), with no significant difference between cyclosporine and corticosteroid-only (z=-0.77, p=0.44) or tacrolimus (z=-1.08, p=0.28). The pooled recurrence rate was 10.2% (95%CI=7.1%-14.5%, I�=10%), and similarly, no differences were observed between treatment groups (p>0.05). Improvement in BCVA from baseline was reported in six studies with tacrolimus (0.03% eye drops: p=0.001; 0.02% ointment: p=0.007; 0.1% ointment: p<0.001; 0.3% ointment: p=0.007-0.042) and one study using 0.05% cyclosporine eye drops (p=0.002).
Conclusion
Topical cyclosporine, tacrolimus, and corticosteroids showed comparable efficacy for managing post-EKC SEIs, with several formulations also improving visual outcomes. However, substantial heterogeneity persists across studies, underscoring the need for standardized treatment protocols and consensus guidelines.
Presenting Author
Nadav Shemesh, Sr., MD, MHA
Co-Authors
Benjamin Stern (MD), Nir Erdinest (PhD, BScOptom), David Smadja (MD), Itay Lavy (MD)
Purpose
To investigate the potential of Ripasudil, a ROCK inhibitor, in managing corneal edema associated with Fuchs' endothelial corneal dystrophy (FECD). FECD causes progressive endothelial loss leading to corneal edema, visual impairment, and potential blindness if untreated, requiring effective therapeutic interventions.
Methods
This case series presents three patients with FECD who were treated with Ripasudil after conventional treatments failed to improve corneal edema.
Results
Case 1: A 68-year-old female with central corneal edema (CCT 632 µm, BCVA 0.4) showed no improvement with Hyper-CL lens and prednisolone 1%. After 11 months of Ripasudil, CCT decreased to 601 µm, BCVA improved to 0.3, with reduced corneal haze and slight IOP elevation. Case 2: A 69-year-old male with central/inferior stromal edema (CCT 686 µm, BCVA 0.3 logMAR) was unresponsive to sodium chloride 5%. Four months of Ripasudil reduced CCT to 595 µm and improved BCVA to 0.0 logMAR. Case 3: A 71-year-old female with central stromal edema (CCT 730 µm, BCVA 0.50 logMAR) failed six weeks of sodium chloride. Six months of Ripasudil reduced CCT to 560 µm and improved BCVA to 0.22 logMAR.
Conclusion
Collectively, these cases suggest that Ripasudil has potential efficacy in reducing corneal edema and enhancing visual outcomes in patients with FECD, offering a promising alternative when standard treatments are ineffective.
Presenting Author
Apeksha M. Kataria, DNB
Co-Authors
Rohit Shetty (FRCS), Swaminathan Sethu (PhD), Abha Shah (MS)
Purpose
Ocular surface inflammation due to various aetiologies including the use of cosmetics can contribute towards ocular surface diseases and sub-optimal post-operative outcomes. Hence, biological cleansing of the ocular surface pre-operatively is essential to reduce the inflammatory factors and improve ocular surface health and post-op outcome.
Methods
The current prospective study involved 30 volunteers. The matched tear fluid (TF) levels of inflammatory biomarkers were measured in samples collected before and after the use of biological cleansing strategy such as the use of medicated lid-wipe or non-medicated lip-wipe to remove the applied eye cosmetic. Further, the effect of trehalose-based eye drops and medicated lid-wipe use on the levels of basal TF inflammatory factors were also determined. The levels of factors associated with ocular surface inflammation such as IL-1?, IL-6, IL-10, IL-17A, TNF?, ICAM1, MMP9, and VEGF-A were measured using microfluidics cartridge- and/or bead-based multiplex ELISA.
Results
The levels of TF inflammatory factors such as IL-6, IL-17A, TNF?, MMP9, and ICAM1 where significantly (P<0.05) lower in samples collected from eyes in which medicated lid-wipes were used to remove eye cosmetics compared to those who used non-medicated lid-wipes to remove eye cosmetics. Further, medicated lid-wipe or trehalose-based eye drop use showed a significant (P<0.05) decrease in the levels of TNF?, IFN?, IL-4, MMP9, and/or MMP9/TIMP1 ratio compared to pre-treatment levels.
Conclusion
Use of eye cosmetics increases ocular surface inflammatory levels and, the use of biological cleansing strategies such as medicated-lid wipe or trehalose-based eye drops reduce the inflammatory load on the ocular surface. Hence, pre-op biological cleansing protocols would substantially improve post-op outcomes of refractive and cataract surgeries.
Presenting Author
Sharon Zhao, MD
Co-Authors
Alexandra Kiszluk (MD), Leangelo Hall (MD), Ramy Rashad (MD, MBA), Abdelrahman Elhusseiny (MD), Swapna Shanbhag (MD), James Chodosh (MD, MPH), Hajirah Saeed (MD, MPH)
Purpose
There is currently no standardized systemic treatment protocol for Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), and many adjunct immunomodulatory therapies have been proposed for the acute phase of disease. We aim to investigate the effects of systemic immunomodulatory therapies on ocular outcomes in SJS/TEN.
Methods
In this retrospective multicenter study, patients were included if they were admitted for acute SJS/TEN and had follow up for at least 3 months from disease onset. Patients were divided into five groups based on immunomodulatory therapy received during the acute phase: systemic corticosteroids, intravenous immunoglobulin (IVIG), systemic corticosteroids and IVIG, systemic corticosteroids and cyclosporine, or supportive care only. Systemic therapy was initiated within seven days of disease onset. Chronic ocular outcomes using the Sotozono scale at final follow-up were compared using generalized estimating equations or Fisher's exact test.
Results
A total of 74 eyes (37 patients) were included (13 M, 24 F). Mean age was 30.2±17.0 years, and median follow-up was 32.2 months (3-108 months). Thirteen patients had SJS, eight had SJS-TEN overlap, and 16 had TEN. Among the treatment groups, there was no significant difference in best-corrected visual acuity, chronic ocular surface complication score, frequency of meibomian gland dysfunction or limbal stem cell deficiency, or the need for mucous membrane graft or scleral lenses at final follow-up. No significant differences were seen in age, sex, acute ocular severity, acute systemic disease severity, interval between disease onset and initiation of systemic treatment or length of follow-up.
Conclusion
We found no significant difference in ocular outcomes in patients with SJS/TEN treated with various systemic immunomodulatory therapies. Targeted local therapy should remain the mainstay for ocular disease in SJS/TEN. Large-scale, prospective studies will allow definitive assessment of the benefits and risks of immunomodulatory therapy in SJS/TEN.
Presenting Author
Zeenal G. Dabre, MBBS
Co-Authors
Christine Mun (MS), Kiera Byrne (None), Natalie Ungaretti (BSc), Sandeep Jain (MD)
Purpose
Corneal staining, performed with fluorescein (FL) sodium dye, is a frequently used efficacy endpoint in dry eye disease (DED) clinical trials. We critically analysed the outcomes with fluorescein corneal staining in clinical trials.
Methods
A review of DED clinical trials up to April 2025 was conducted. Data from twenty-three clinical trials of seven FDA-approved DED therapies using corneal FL staining as an efficacy endpoint was used for analysis. Relevant data for these clinical trials was retrieved from 15 published articles, clinicaltrials.gov, accessdata.fda, and the new drug application database. To assess clinical relevance, a minimal clinically important difference (MCID) was pre-defined as a change of ?3 in corneal staining, based on findings from previous studies. To determine the magnitude of the difference in corneal FL staining between the drug and the vehicle, the effect size was calculated using Cohen's D.
Results
Twenty-two of the twenty-three trials (95.65%) of the currently approved DED therapies used corneal FL staining as an efficacy endpoint, and half (50%) of these trials failed to meet the efficacy endpoint. Amongst the trials that met corneal staining as a primary efficacy endpoint, the effect size was small in all trials (100%). Only 1 trial achieved an MCID. Across all the trials, the maximum additional reduction in corneal staining seen with the investigational drug compared to placebo (from first to last visit) was 1.2 points, as observed in the MOJAVE trial. There was a high variability in the FL read-out time, and the grading scales used in these trials relied on discrete punctate dots.
Conclusion
Half of the clinical trials of approved DED therapies failed to meet corneal FL staining endpoint. These shortcomings could stem from inherent limitations of FL. A key limitation is that FL tends to diffuse over time, blurring dots, while grading scales rely on discrete punctate dots. Variability with time could further undermine reproducibility.
