Moderator
Marjan Farid, MD, ABO
Panelists
Michael Mimouni, MD
Marisa Schoen, MD, 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
Christine K Kim, BA
Co-Authors
Blaze Ann Carbonell BSc, Christopher Yang BSc, David Morcos BA, Olivia Lee MD, Jordan Tang BSc
Purpose
To investigate the effects of cyclosporine eye drops on the corneal epithelium and sub-basal nerve plexus using in vivo confocal microscopy (IVCM).
Methods
This retrospective study evaluated the use of topical cyclosporine (either commercially available 0.05% or 0.09% twice daily) in medication-naive eyes clinically diagnosed with dry eye disease. IVCM images of central corneas were obtained prior to and three months after treatment. Two independent, masked graders manually analyzed the IVCM images. A student t-test compared DC density, nerve density, nerve reflectivity, nerve tortuosity, epithelial wing and basal cell density before and after treatment.
Results
Sixty-one eyes of 31 patients (20 women; mean age 59.3 � 18.4 years) completed the study. Thirty-three eyes were treated with cyclosporine 0.05% and 28 eyes with cyclosporine 0.09%. Three images were omitted due to poor image quality. Both cyclosporine 0.05% and 0.09% treatments significantly reduced DC density, with 0.05% decreasing from 61.19 � 54.00 to 47.17 � 49.58 cells/mm� (p < 0.05, n = 32) and 0.09% from 64.87 � 45.24 to 34.90 � 31.88 cells/mm� (p < 0.001, n = 26). Nerve density, reflectivity, tortuosity, and epithelial cell density did not change significantly with cyclosporine use (p > 0.05) after 3 months of treatment.
Conclusion
Cyclosporine-treated dry eye showed reduced corneal DC density after 3 months of treatment. No statistically significant changes were found in nerve density, reflectivity, tortuosity, or epithelial cell density. More research is needed to understand cyclosporine�s long-term effects on corneal nerves, epithelial cells, and its clinical implications.
Presenting Author
Jeff Wongs, MD
Purpose
To assess the use of self-retained cryopreserved amniotic membrane (AM) in restoring corneal health prior to cataract surgery and improving the accuracy of pre-operative biometric readings for intraocular lens (IOL) calculations to enhance post-operative refractive outcomes.
Methods
A single-center, prospective study evaluating self-retained cryopreserved AM (Prokera� Slim) in eyes with moderate to severe dry eye disease (SPEED score ? 10 & NEI corneal staining ? 4) prior to cataract surgery. Biometry, corneal staining (NEI scale), SPEED scores, and best corrected visual acuity (BCVA) were assessed before and after AM treatment as well as 1-month post-cataract surgery. Post-surgical refraction was compared to refractive target, and the proportion of patients who achieved emmetropia (defined as spherical equivalent [SE] �0.5 D and <1.0 d="" astigmatism)="" was="">
Results
A total of 55 eyes (37 patients) completed the study. SPEED scores and NEI scores significantly improved at 1- and 2-weeks post-treatment, with sustained benefit at 1 month post-op (P<0.001). at="" 1="" month="" post-op,="" 93%="" of="" eyes="" had="" 20/20="" bvca,="" and="" emmetropia="" was="" attained="" in="" 84%="" of="" eyes.="" biometry="" performed="" after="" treatment="" with="" cam="" was="" more="" accurate,="" with="" more="" eyes="" within="" �0.25d="" (70%="" vs.="" 36%,="" p="0.002)," �0.5d="" (94%="" vs.="" 66%,=""><0.001), �0.75d="" (98%="" vs.="" 76%,=""><0.001), and="" �1d="" (100%="" vs.="" 86%,="" p="0.016)" following="" treatment.="" furthermore,="" average="" deviation="" from="" refractive="" target="" at="" 1="" month="" was="" significantly="" lower="" than="" the="" predicted="" refractive="" error="" prior="" to="" cam="" (0.22="" �="" 0.22="" d="" vs.="" 0.55="" �="" 0.46="" d,="">< />
Conclusion
Optimization of the ocular surface with cAM can significantly improve both signs and symptoms of moderate to severe DED within 1 week, with sustained improvement noted at 1 month post-operatively. Furthermore, treatment with cAM can improve biometry accuracy, reduce post-operative refractive error, and yield good visual outcomes.
Presenting Author
David L Wirta, MD
Co-Authors
Michelle Senchyna PhD, Sheila Garcia Santana MD, David Almeida MD, MBA, PhD, Sherif El-Harazi MD, MPH, Brad Kligman MD
Purpose
Acoltremon 0.003% (ACO) is a potent TRPM8 agonist being developed for the treatment of dry eye disease (DED). In 2 Ph3 studies, ACO led to an increase in tear production as early as the first dose and throughout the 90-day treatment period. This study investigates ACO-stimulated tear production for up to 12 months in the Ph3 COMET-4 [C4] study.
Methods
C4 was a Ph3 long-term safety study. Qualified subjects with DED were randomized 2:1 to receive ACO or vehicle (VEH) BID in both eyes for 12 months. Tear production, measured as exploratory efficacy, was assessed with the unanesthetized Schirmer test (ST) in a subgroup of subjects at selected sites. The percent of subjects with ?10 mm increase in ST score and change from baseline (CFB) ST score at each visit was analyzed with the Fisher exact test and ANCOVA, respectively. Safety assessments were performed at all visits for the entire study cohort.
Results
In the exploratory efficacy subgroup (ACO, n=28; VEH, n=14), tear production in favor of ACO was consistently observed through 12 months. Day (D) 1 and D365 response rates for ACO vs VEH were 53.6% vs 7.1% and 60.0% vs 0%, with treatment differences of 46.4% (P=0.0058) and 60% (P=0.0007), respectively. The LS mean CFB � SE for ACO and VEH at D1 was 14.6 � 1.90 vs 3.4 � 2.69 and at D365 was 14.8 � 1.96 vs 0.6 � 2.95, with treatment differences of 11.3 � 3.30 (P=0.0015) and 14.2 � 3.54 (P=0.0003), respectively. In the full safety cohort (n=275), the most common ocular adverse event was instillation site burning/stinging, which was rated as mild by the majority of those reporting it.
Conclusion
Aligned with mechanism of action, acoltremon 0.003% demonstrated rapid onset and sustained improvement in tear production over 12 months, with a favorable safety profile. These results, consistent with previous Ph3 pivotal efficacy studies, support acoltremon 0.003% as a promising novel treatment for the signs and symptoms of DED.
Presenting Author
Olivia L. Lee, MD, ABO
Co-Authors
John Hovanesian MD, Thomas Lin PhD, Jinsong Ni PhD, Rong Yang PhD, Scott Whitcup MD
Purpose
Pterygium affects up to 15 million in the US, of which 2.5 million have been diagnosed. Little is known about clinical characteristics correlated with pterygium progression. The purpose of this phase 2 post hoc analysis was to evaluate clinical characteristics that provide insights into which patients with pterygium may experience progression.
Methods
Data were analyzed from a phase 2 randomized clinical trial on the safety and efficacy of CBT-001, a topical multikinase inhibitor. In a post hoc analysis, correlations between disease characteristics at baseline from 48 patients (study arm, n=25; placebo arm, n=23) and through 6 months (placebo arm, n=23) were studied. Baseline characteristics including age, sex, pterygium type, duration of disease, symptoms, vascularity, and hyperemia were assessed using Spearman correlation coefficients (CC) for continuous variables and t-tests for dichotomous variables.
Results
At baseline, the median age of patients was 52.5 years. Pterygium length was correlated with vascularity (CC = 0.64; P<0.001) and="" conjunctival="" hyperemia="" (cc="0.473;" p="0.001)," but="" these="" factors="" did="" not="" predict="" pterygium="" progression="" (p="0.507" and="" p="0.160," respectively).="" greater="" progression="" occurred="" in="" patients="" younger="" than="" the="" median="" age="" (cc="�0.508;" p="0.013)" and="" in="" those="" with="" recurrent="" pterygium="" (p="">
Conclusion
Age was negatively correlated with pterygium progression with younger patients showing greater progression. In addition, progression was more common in patients who had recurrent pterygium following surgery. Future studies should continue to investigate the impact of clinical characteristics on pterygium progression.
Presenting Author
Francis S. Mah, MD
Co-Authors
Abhishek Nair PhD, MS, Victoria Divino BA, Swapna Munnangi PhD, Elizabeth Langford MPH
Purpose
Dry Eye Disease (DED) is a chronic multifactorial disease of the tear film and ocular surface causing discomfort, visual morbidity, and potential permanent damage to the ocular surface. Patients tend to discontinue or switch eye care providers (ECP) frequently. The objective of the study is to identify the diagnosing ECP�s patient retention.
Methods
A retrospective cohort study using the IQVIA PharMetrics� Plus database of adjudicated claims linked to the OneKey Healthcare Professional database (1/2020 � 10/2023). Adult patients newly diagnosed with DED by an ECP and without prior DED therapy were identified (diagnosis date = index date). Patients were followed for one year after their index date. Patient retention was defined as a return visit to their diagnosing ECP over the 1-year follow-up. Patient retention was compared between patients with and without a claim for DED therapy within 60-days of follow-up.
Results
Overall, 598,430 patients with a DED diagnosis met the eligibility criteria (mean age 53.9 years; 66.0% female). Over the 60-day follow-up, only 2.6% patients received a DED therapy. Over the 1-year follow-up, more than half (54.9%) of the patients in the DED therapy group returned to their diagnosing ECP compared to 29.7% in the non-DED therapy group. Of those patients with a return visit over the 1-year follow-up, 82.7% in the DED therapy group returned to their diagnosing ECP for their first follow-up DED-related medical claim compared to 60.4% in the non-DED therapy group. Findings were statistically significant between groups.
Conclusion
Majority of the DED patients (98.4%) did not receive a DED therapy within 60 days post-diagnosis. Patient retention to the diagnosing ECP was higher in those that received a DED therapeutic recommendation over the 60-day follow-up compared to those that did not. This study highlights that ECPs who recommended a therapy had higher patient retention.
Presenting Author
Shizuka Koh, MD, PhD
Co-Authors
Tomo Suzuki PhD, MD, Shigeru Kinoshita MD, PhD, Reiko Arita PhD, MD, Kavita Dhamdhere MD, PhD, Elizabeth Yeu MD
Purpose
To establish the prevalence of Demodex blepharitis (DB) and understand DB symptomology in Japan.
Methods
Elara was an observational, multicenter, cross-sectional (single visit) study conducted in Japan. Patients, who were at least 20 years old, with normal eyelid anatomy, and without active ocular infection or treatment for blepharitis were enrolled. The presence of DB (?1 collarette in any eyelid) was recorded and analyzed. Other key outcomes included mite density, collarette severity, lid margin erythema (LME), and visual analog scale (VAS, 0-100 rating scale).
Results
A total of 349 patients (mean age of 51 years, and 61% female) from 10 sites across Japan were enrolled. The prevalence of DB was 66.5%. The DB group had a significantly higher number of patients with LME grade ?1 (43% vs. 12%, p<0.05) than="" the="" non-db="" group.="" the="" majority="" (86%)="" of="" db="" patients="" reported="" at="" least="" 1="" symptom;="" symptoms="" mostly="" worsened="" with="" increased="" collarette="" grade.="" the="" vas="" scores="" for="" itching="" (25="" vs.="" 18,="" p="0.01)" and="" fluctuating="" vision="" (25="" vs.="" 17,="" p="0.01)" were="" significantly="" worse="" in="" db="" patients="" than="" patients="" without="">
Conclusion
Prevalence of DB in Japan was higher than what was observed in the US. Similar to previous studies, most patients reported at least 1 symptom, and in DB patients, itching was the most commonly reported symptom.
Presenting Author
Neslihan D. Koseoglu, MD
Co-Authors
Luiz Luciano Lamazales MD, Ana Balbuena-Pareja MD, Stephanie Cox OD, William Binotti MD, Onur Olcucu MD, FEBO, Sandra Hunt BA, Pedram Hamrah MD, Chloe Bogen MS
Purpose
This study aims to assess if anterior segment-optical coherence tomography (AS-OCT) epithelial thickness mapping (ETM) can detect early epithelial thickness (ET) changes in stage 1 neurotrophic keratopathy (NK1) as compared to dry eye disease (DED) and whether recombinant human nerve growth factor (rhNGF) can reverse these changes.
Methods
This retrospective study involved 12 NK1 patients (diagnosed based on central corneal sensation <4 cm,="" as="" measured="" by="" the="" cochet-bonnet="" esthesiometer,="" with="" +3="" central="" corneal="" staining="" the="" nei="" scale)="" and="" 15="" ded="" patients="" (diagnosed="" based="" clinical="" signs="" and="" symptoms).="" all="" patients="" underwent="" as-oct="" with="" corneal="" etm.="" et="" was="" calculated="" for="" the="" central="" 0-2="" mm,="" 2-5="" mm="" and="" 5-7="" mm="" areas="" (mean="" �m="" �="" standard="" deviation).="" correlations="" between="" et="" and="" nerve="" density="" (nd),="" as="" assessed="" by="" in="" vivo="" confocal="" microscopy,="" were="" performed.="" six="" nk1="" patients,="" who="" completed="" an="" 8-week="" course="" of="" rhngf="" therapy="" and="" had="" as-oct="" etm="" pre-="" and="" post-treatment,="" were="" further="">
Results
There were no differences in age and gender between groups (p>0.05). ET was globally reduced in NK1 compared to DED: 0-2 mm: 43.79�5.01 vs 53.26�2.52, 2-5 mm: 44.34�4.11 vs 53.48�2.46 and 5-7 mm: 44.20�4.64 vs 52.63�1.64 (p<0.001 for="" all).="" minimum="" et="" values="" were="" indicative="" of="" nk1="" with="" 83.3%="" sensitivity,="" 86.7%="" specificity,="" and="" an="" auc="" of="" 0.903,="" compared="" to="" ded=""><0.001). main="" nd="" and="" et="" values="" significantly="" correlated="" in="" the="" 0-7="" mm="" zone="" [?="0.70" (95%="" ci:="" 0.37,="" 0.88),=""><0.001]. interestingly,="" while="" rhngf="" treatment="" resulted="" in="" increased="" et="" values="" ranging="" from="" 14.1%="" to="" 14.5%="" in="" all="" areas=""><0.05 for="" all),="" they="" still="" remained="" significantly="" thinner="" in="" the="" 0-2="" mm="" and="" 2-5="" mm="" zones="" compared="" to="">
Conclusion
AS-OCT ETM demonstrates global ET thinning in NK1 and may aid in the differentiation of NK1 from DED. While ET was significantly increased in NK1 after rhNGF treatment, it remained reduced compared to DED. Larger studies are needed to confirm these results.
Presenting Author
Isabela Yang, MD
Co-Authors
Ana Balbuena-Pareja MD, Neslihan Koseoglu MD, Benjamin Lee BA, Chloe Bogen MS, Stephanie Cox OD, Pedram Hamrah MD
Purpose
Neurotrophic keratopathy (NK) is characterized by corneal nerve dysfunction that may result in superficial punctate keratitis (SPK) or persistent epithelial defect (PED). This study aims to assess the effects and complications of cryopreserved amniotic membrane transplantation (AMT) in NK patients.
Methods
This retrospective longitudinal study included NK patients seen in the Cornea Service of the New England Eye Center between 2015 and 2022. Patients with decreased corneal sensation (?4 as measured by Cochet Bonnet esthesiometer) and/or lack of nerves on in vivo confocal microscopy were included. Patients with SPK were grouped as stage 1 NK (NK1) and patients with persistent epithelial defects (PED) and/or ulcers were grouped as stage 2/3 (NK2/3). Changes in the severity of SPK (assessed by corneal fluorescein staining[CFS;Oxford scale]) and the area of PED/ulcers before and after AMT were evaluated. The pre- and post-AMT difference in visual acuity (VA, recorded in logMAR) was also assessed.
Results
16 eyes of 15 patients (age=57.1�17.3 years; 73.3% female) were included in the data. The mean number of lenses used was 2.5�1.4, with a mean duration of 30.4�20.1 days from first to last AMT. NK1 (n=8) patients showed improvement in CFS severity (pre:3.4�0.8; post:1.9�1.1; p=0.008). NK2/3 patients (n=7) had a mean PED area 5.4�7.3mm2 prior to AMT. Total closure was seen in 85.7% post-AMT, with 1 patient developing fungal keratitis, and 1 patient with increased PED size. VA showed significant improvement (pre:1.1�0.8; post:0.6�0.7; p=0.014) with AMT. Thirteen patients (NK 1=7; NK 2/3=6) had at least one follow-up visit and 92.8% had a recurrence (SPK or PED) with a mean of 111.9�89.8 days.
Conclusion
This study shows temporary improvement in epithelial integrity and VA with cryopreserved AMT in NK patients. Complications may occur in particular in NK2 patients. Further prospective randomized trials are necessary to elucidate the long-term safety and efficacy of AMT in NK patients.
Presenting Author
Oase Sbei, BA
Co-Authors
Qais Dihan BSc, Waleed Kojan BSc, Abdelrahman Elhusseiny MD
Purpose
To analyze frequency, symptom onset, and demographic distribution of ophthalmologic adverse events reported in CDC-VAERS following COVID-19 vaccination.
Methods
Data from the CDC-VAERS Database was filtered for ophthalmologic symptoms, vaccines, and age ranges. Cases were categorized by onset interval, dose, year reported, sex, and state, using VAERS IDs for identification. Duplicates were manually verified, and cases with multiple doses were labeled �unknown.�
Results
Results: A total of 1,009 ophthalmology-related cases were reported from 2020 to May 2024, mainly in 2021 (737 cases) and 2022 (233 cases). The Pfizer-BioNTech vaccine was involved in 94.05% of cases. Females represented 55.10% of reports, with symptoms mostly beginning on the day of vaccination (62.33%) and after the first dose (58.17%). Blurred vision was the most common symptom (42.02%), primarily in females (57.98%). Redness of the eye was reported in 159 cases, more common in males (56.60%). Less frequent were eyelid symptoms (2.38%) and corneal symptoms (9 cases). Other symptoms included iridocyclitis (4), retinal vein occlusion (1), and vitreous floaters (10).
Conclusion
The most commonly reported adverse ophthalmological events in the pediatric population post-COVID19 vaccination were linked to Pfizer-BioNTech, though they were rather rare. The VAERS reporting system highlights the need for continued safety monitoring to monitor the frequency of symptom reports overall in the pediatric population.
Presenting Author
Maria Laura Gomez, MD
Co-Authors
Natalie Afshari MD
Purpose
Meibomian Gland Dysfunction comprises 70-90% of dry eye patients. Treatment include lid hygiene, warm compresses and eye drops with variable results and challenging compliance. In office procedures involving removal of inspissated lipids have become the mainstream. We wanted to analyze the need for supplemental topical therapy after such treatments
Methods
Out of 1050 dry eye patients, 830 patients had clinically diagnosed MGD and were treated with a single treatment of Lipiflow (201) or TearCare (214) , 3 Mibo Thermoflo applications (217) or 4 Intense Pulsed Light (IPL) sessions (198) by a single physician in a standardized manner. Outcomes included two validated questionnaires, tear film break-up time, corneal and conjunctival staining, meibography, MG expressibility, and tear osmolarity. Wilcoxon rank-sum and stacked modeling statistics evaluated patients before and after 3 months and adjusted for inter and intra eye data.
Results
Statistically significant improvement was observed in both SPEED and OSDI questionnaires (p<0.03), and="" in="" all="" objective="" parameters="" measured="" (p="" ranged="" from="" 0.03="" to="" 0.05).="" there="" was="" no="" statistical="" difference="" in="" lipid="" expression="" in="" terms="" of="" mg="" expressibility="" and="" meibum="" quality="" 3="" months="" after="" each="" procedure=""><0.05). 26%="" required="" punctal="" plus="" after="" the="" procedure="" but="" surprisingly="" 96%="" of="" patients="" did="" not="" require="" immunomodulators="" 9="" months="" after="" the="" last="" in="" office="">
Conclusion
Treating the clogged glands in MGD brings homeostasis to the tear film in the ocular surface without the need to keep these patients on long term immunomodulators. Dropless Dry Eye Therapy is now a reality. Our study provides valuable insights into the role of restoring lipid homeostasis in patients with MGD.
Presenting Author
Pooja Khamar, MD, PhD
Co-Authors
Rohit Shetty FRCS, Arkasubhra Ghosh PhD, Swaminathan Sethu PhD
Purpose
Dry eye disease (DED) has diverse clinical manifestations, making treatment challenging. Accurate patient classification is essential for optimizing treatment and improving surgical outcomes. Using an AI-based classifier, we identified patients at risk of DED or ocular surface inflammation based on tear biomarkers.
Methods
We measured 8 biomarkers in tears collected using Schirmer�s strips from 640 subjects. The subjects were categorized into clinical groups of controls and Dry Eye Disease (DED) based on Schirmer�s test, TBUT, and OSDI scores. An AI model using a decision tree classifier (DTC) analyzed the biomarker levels, identifying MMP-9 as the primary discriminator. The cohort was further divided into four groups based on MMP-9 levels: Controls (n=318), SC-1 (low to moderate MMP-9, n=72), SC-2 (moderate to high MMP-9, n=101), and DED (extremely high MMP-9, n=149). A Random Forest (RF) AI model was then used to classify the cohort, excluding MMP-9, with and without clinical parameters.
Results
The DTC AI model had an AUC of 0.76 and correctly predicted 68% of Group-1 eyes and 71% of Group-2 eyes. In the second strategy, Controls and DED eyes significantly (p < 0.001) correlated with the clinical parameters (TBUT, Schirmer�s and OSDI). However, this correlation wasn�t significant in the sub-clinical groups (p>0.05) indicating the need for reclassifying them. The RF AI model (MMP9-based grouping) had an AUC of 0.79 with 94.8% sensitivity and 88.6% specificity. When clinical parameters were included in the model, the accuracy slightly improved to 0.81, and specificity towards DED eyes increased to 78%.
Conclusion
MMP-9 cutoff level for controls was determined by AI model to subdivide apparently healthy eyes into sub-clinical groups at risk of DED. Biomarker-based subgrouping correlated well with clinical parameters-based subgrouping of the DED cohort which is useful for stratification of subjects in a clinical setting.
Presenting Author
Mohammadali Ashraf, MD
Co-Authors
Aron Sebhat MS, Riley Ferguson MD, Ahmad Alzein BA, Hajirah Saeed MPH, MD
Purpose
Ocular surface keratinization (OSK) as a result of Steven Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) is a severe complication that traditionally has few options for restoration of the ocular surface and visual rehabilitation. This case series explores the use of Vitamin A loaded autologous serum tears (VAAST) to reduce OSK in SJS/TEN.
Methods
A retrospective chart review of three patients (six eyes) was performed, concentrating on visual acuity (VA) and slit-lamp examination results. For patients with ocular surface keratinization (OSK) in the chronic phase of SJS/TEN, Vitamin A-loaded autologous serum tears (VAAST) were prescribed. The preparation involved patients taking ten 8000 IU Vitamin A tablets the night before the blood draw, with the resulting serum tears applied to the ocular surface four times daily.
Results
Case 1, a 28-year-old woman with severe keratinization and hand motion (HM) vision in both eyes (OU) experienced near-complete resolution of OSK and improved to counting fingers (CF) vision after 2 weeks of VAAST, after which she underwent limbal stem cell transplantation (LSCT). Case 2, a 40-year-old man with corneal keratinization and neovascularization saw his VA improve from 20/600 OD and 20/300 OS to 20/200 OU after 2 weeks of VAAST, with significant OSK resolution; he is awaiting LSCT. Case 3, a 23-year-old man with corneal keratinization and CF vision OU improved to 20/250 OD and 20/600 OS after 6 months of VAAST, with OSK nearly resolved in OD. No reactions to Vitamin A were observed
Conclusion
The administration of VAAST can significantly improve OSK and lubrication, improving VA and symptoms, and optimizing the ocular surface for further surgery. While further investigation is needed, this treatment may provide a non-invasive option for treatment in a devastating and blinding disease.
Presenting Author
David L Wirta, MD
Co-Authors
Francis Mah MD, Sam Garg MD, Kelly Nichols PhD, OD, MPH, Yair Alster MD, Charles Bosworth PhD
Purpose
MGD can be diagnosed based upon abnormal meibomian gland morphology and function alone. AZR-MD-001 (AZR) 0.5% is a keratolytic, keratostatic and lipogenic compound directly targeting abnormal meibomian gland morphology and function. AZ202401 (NCT06329791) is a Phase 3 study enrolling adult patients with early to moderate MGD without severe DED.
Methods
This Phase 3, prospective, randomized, double-masked, vehicle-controlled trial (ASTRO Study) includes participants aged 18 and older with mild to moderate MGD (Total OSDI ?13 and <34 and="" meibomian="" gland="" score="" (mgs)="" of="" 2="" for="" 15="" glands="" of="" the="" lower="" lid)="" and="" excludes="" severe,="" inflammatory="" ded="" (i.e.,="" excludes="" aqueous="" deficient="" ded,="" corneal="" staining="" (oxford="" scheme),="" &="" schirmer�s="" assessment="" without="" anesthesia="" mm).="" eligible="" participants="" (n="562)" were="" randomized="" (1:1)="" to="" of="" two="" treatment="" groups="" (azr="" 0.5%="" or="" vehicle).="" therapy="" is="" applied="" to="" the="" lower="" lid="" margin="" twice="" per="" week="" at="" bedtime="" for="" up="" to="" 1="" year.="" masked="" demographic="" data="" is="" presented="" to="" illustrate="" the="" target="" population="" of="">
Results
Based upon masked demographic data, adult (age in years (mean (SD)): 57.2 (14.29)) patients in AZ202401 were 68.3% female with 59.8% classified as White, 23.1% as black, African American, 14.2% as Asian, and the remainder as Pacific Islander, Multiple, or Other. Patients identifying as Hispanic or Latino made up 11.7% of participants. All patients presented with signs of MGD at Baseline: 42.9% presented with a MGS < 6="" and="" 67.6%="" presented="" with="" a="" score="" from="" 6-12="" (study="" eye="" average="" mgs:="" 5.6(3.1))="" and="" symptoms="" of="" mild="" to="" moderate="" disease="" (total="" osdi:="" 24.8="" (5.1))="" at="" baseline.="" the="" study="" was="" completely="" enrolled="" between="" may="" 30th,="" 2024="" and="" september="" 8th,="" 2024="" at="" 15="" sites="" across="" the="" />
Conclusion
The demographic data from this Phase 3 study demonstrates that it is relatively easy to target and successfully enroll patients with early to moderate MGD based upon glandular morphology and mild to moderate symptoms of DED. This is likely driven by the high incidence and lack of effective treatments for these patients within the DED population.
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