2021 ASCRS Annual Meeting

Authors

Presenting Author
Edward J. Holland, MD    Email the author
Authors
Fiona Stapleton, OD, Jennifer P Craig, OD

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Paper Abstract

Purpose
MGD is the leading cause for Dry Eye. Hyperkeratosis and increased disulfide bonds play a major role in the pathogenesis of MGD. AZR-MD-001 contains SeS2, a potent keratolytic agent which also increases lipogenesis. The primary objective of the phase 2 program was to evaluate the efficacy and safety of AZR-MD-001 in patients with MGD.

Methods
The phase 2 program consisted of 4 randomized double-masked, vehicle controlled, multi-center studies conducted to evaluate 3 concentrations of AZR-MD-001 (0.1%, 0.5% and 1.0%) compared to control. A 4mg dose of either drug or matched control was applied to the lower lid twice a week, before bedtime for 3 months. Patients had to be symptomatic and have a Meibomian Gland Score (MGS) ≤12. Evaluations occurred at 14 days and months 1, 1.5 and 3. The primary end points for the study were OSDI, MGS, and MGYLS. Secondary endpoints included TBUT, SPEED and VAS. The prespecified mITT population targeted patients with MGS score ≤ 12 and Total OSDI < 34

Results
Ninety-five (95) patients were included in the study (26, 9, 26 and 34 in control, 0.1%, 0.5% and 1.0%, respectively) At month 3, for both 0.5% and 1%, statistically significant and clinically meaningful reductions were observed in Total OSDI compared to baseline and control with up to 58% of patients becoming non-symptomatic (OSDI <13) compared to 16% in control (p<0.05), in MGYLS score compared to baseline and control with up to 46% of patients achieving a clinically meaningful increase compared to 8% in control (p<0.01) and in MGS with up to 59% returning to a normal range (>12) compared to 31% in control (p<0.05). AZR-MD-001 was well tolerated with no serious ocular adverse events

Conclusion
Topical AZR-MD-001 resulted in significant improvement in both signs and symptoms of mild to moderate MGD. AZR-MD-001 has the potential to be the first pharmacotherapy found to be effective for treating the signs and symptoms of MGD. The Phase 3 program has been initiated.

Authors

Presenting Author
Karl G. Stonecipher, MD, ABO    Email the author

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Paper Abstract

Purpose
The purpose was to show the effects of IPL/LLLT versus LLLT in patients with severe MGD as adjunctive therapy for ocular surface disease prior to refractive cataract and refractive surgery.

Methods
The setting was two offices (cataract and refractive patients) with one surgeon participating. The author treated 526 eyes of 263 patients in a prospective study of IPL/LLLT versus LLLT for treatment of MGD. All patients were treatment failures with previous topical and systemic medications. All patients received complete eye exams with the primary focus on the subjective evaluation of the intervention using the Ocular Surface Disease Index (OSDI) and the objective evaluation of the intervention using Meibomian Gland Expression (MGE) and Tear Break Up Time (TBUT) prior to treatment and 1-3 months after treatment. The subjects were followed for up to one year.

Results
Prior to intervention (IPL/LLLT) the average OSDI score was 44.4. Post treatment it was 25.4. Prior to treatment average MGE was 3.63. Post treatment was 2.36. The MGE was defined on a 4-point scale with 4 being the inability to express meibum and 0 being normal. Initially the average TBUT was 3.78 seconds. Post treatment TBUT increased to 7.56 seconds. In the LLLT only group, significant improvements in the mean OSDI score (p = 0.002), MGD grading (p < 0.001), TBUT (p < 0.001) and both nasal and temporal LG staining (p < 0.02) were observed. An MGD grade reduction of >1 was observed in 72% of eyes (36/50). There were no adverse events. All patients noted improvement with the treatment.

Conclusion
The use of IPL/LLLT or LLLT alone for the treatment of MGD is beneficial in patients who have failed topical and/or systemic therapy. The author will discuss the use of this technology for ocular surface disease and the use of this technology to improve outcomes in refractive and refractive cataract surgery.

Authors

Presenting Author
Eric D. Donnenfeld, MD    Email the author
Authors
Edward J. Holland, MD, Richard L. Lindstrom, MD, Hampar Karageozian, MSc, John Y. Park, PhD, Lisa Karageozian, BSc, Janine Aubel, MBA, Melvin A Sarayba, MD, Vicken Karageozian, MD

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Paper Abstract

Purpose
Risuteganib (RSG) is a small peptide that regulates integrin expression which results in downregulation of inflammation and improvement in signs and symptoms of Dry Eye Disease (DED). A prior dose-ranging study demonstrated a dose effect, with 0.6% RSG showing greatest efficacy. This study evaluates 0.6% RSG against control solutions.

Methods
Subjects with moderate DED were enrolled and randomized to 1 of 4 treatment arms (64 eyes total, 16 eyes per arm): vehicle, 0.125% sodium hyaluronate (SH), 0.6% RSG, and 0.6% RSG + SH. Treatment was administered 1 drop 2x per day for 12 weeks. Assessments were done at weeks 2, 4 8 and 12. Signs were assessed using tear break-up time (TBUT), cornea and conjunctival staining. Symptoms were assessed using VAS and the UNC Dry Eye Management Scale (DEMS). Co-primary endpoints: change in nasal conjunctival staining and DEMS score. Secondary endpoints: change in TBUT, total ocular staining, VAS score, and inferior cornea staining. Safety endpoints were: adverse events and biomicroscopy.

Results
All primary and secondary endpoints were met. The results show that improvement in all the signs and symptoms at week 12 were statistically greater (p<.001) in the: SH group compared to the vehicle group; RSG group compared to the vehicle group; RSG group compared to the SH group; and RSG+SH group compared to the SH group. Furthermore, the RSG+SH group demonstrated the most robust improvement in signs and symptoms. The effect of RSG+SH is more than just additive but indicated a synergistic effect. Subjects did not report any prolonged blurring of vision or ocular irritation with any of the test solutions. There were no reported drug-related adverse events or serious adverse events.

Conclusion
In conclusion, 0.60% RSG and 0.60% RSG + 0.125% SH solutions demonstrated statistically significant superior improvement of signs and symptoms compared to control solutions in subjects with DED. Both active solutions demonstrated excellent safety profile and were well tolerated with no reported blurring of vision or ocular irritation.

Authors

Presenting Author
Kamran M. Riaz, MD    Email the author
Authors
Victoria A Bugg, MD

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Paper Abstract

Purpose
Dry eye syndrome (DES) is a known complication of bilateral upper eyelid blepharoplasty. Our study aims to determine the incidence of DES in patients undergoing blepharoplasty surgery, and to evaluate for a difference in post-operative symptoms in patients undergoing blepharoplasty using an orbicularis-sparing vs. orbicularis excising technique.

Methods
This is a prospective randomized controlled clinical trial whereby patients undergoing upper eyelid blepharoplasty underwent pre-operative clinical assessment of DES with multiple objective tests including: tear break up time, Schirmer’s test, Lipiview, Inflammadry, lagophthalmos grading, and lissamine staining, along with evaluation of subjective symptoms using the SPEED score. A diagnosis of DES was made if the patient had at least one abnormal objective and subjective finding. The patients were randomized into two surgical groups: orbicularis sparing and orbicularis excising techniques. The SPEED score was then determined post-operatively at one month and one year.

Results
62 patients were randomized into the orbicular-sparing or orbicularis-excising groups. Pre-operatively, 30% had at least one abnormal objective finding, and abnormal subjective symptoms and were diagnosed with DES. Lissamine staining was found to be a helpful predictor for a diagnosis of DES; with staining present in 68.4% of the DES group compared to 36% of the control group (p = 0.04). There was a statistically significant improvement of in the SPEED score in both groups, with -3.4 points at POM1 (p<0.0001), and -3.0 points at POM12 (p<0.0001). Both groups also had an improvement in the Schirmer’s test, which was statistically significant at 1 year post-op (+3.3 mm, p = 0.0098).

Conclusion
A significant portion of patients presenting for blepharoplasty surgery have undiagnosed Dry Eye Syndrome, and the SPEED Score and Lissamine staining can be helpful screening tools during the pre-operative evaluation. Conservative blepharoplasty resulted in improved SPEED scores in both the orbicularis-sparing and orbicularis-excising groups.

Authors

Presenting Author
Kimberley Yu    Email the author
Authors
Vatinee Bunya, MD, ABO, Maureen G. Maguire, PhD, Penny A. Asbell, MD, MBA, ABO, Gui-shuang Ying, PhD

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Paper Abstract

Purpose
To evaluate the associations of systemic conditions with the severity of dry eye disease (DED) signs and symptoms in a well-characterized cohort of 535 patients with moderate-to-severe DED in the Dry Eye Assessment and Management (DREAM) Study, a randomized clinical trial to evaluate the safety and effectiveness of omega-3 supplements to treat DED.

Methods
Patients reported their medical history at baseline. At baseline, 6 months, and 12 months, patients were assessed for DED symptoms using the Ocular Surface Disease Index (OSDI) and for six DED signs: tear break-up time, Schirmer’s test, corneal staining, conjunctival staining, tear osmolarity, and meibomian gland dysfunction. A composite signs severity score with range 0-1 (1 most severe) was calculated from the six DED signs. We analyzed the associations of systemic conditions reported as potential DED risk factors with the severity of DED signs and symptoms using generalized linear regression models adjusted by age, sex, race, and visit. To be included, conditions had at least 25 patients.

Results
The mean±SD age was 58±13.2 years, and 81% were female. Significant associations with the severity of DED signs were found for Sjögren’s syndrome (composite mean±SD: 0.52±0.17 with disease vs. 0.43±0.13 without disease, p<0.001), facial rosacea (0.47±0.13 vs. 0.43±0.13, p=0.002), rheumatoid arthritis (0.47±0.14 vs. 0.42±0.12, p=0.002), peripheral artery disease (0.50±0.14 vs. 0.43±0.13, p<0.001), and daily smoking history (0.45±0.13 vs. 0.43±0.13, p=0.047). Thyroid dysfunction, osteoarthritis, diabetes, irritable bowel syndrome, hypercholesterolemia, hypertension, and hypertriglyceridemia were not significantly associated with DED signs. No conditions were significantly associated with OSDI.

Conclusion
In the DREAM study, severity of DED signs was associated with the presence of certain systemic diseases and with smoking. The profile of significant DED signs varied by systemic condition, reflecting different DED etiologies. This is, to our knowledge, the largest cohort study to explore associations between systemic conditions and DED severity.

Authors

Presenting Author
Priscilla Q. Vu, MD, MS    Email the author
Authors
Yan Li, PhD
David Huang, MD, PhD, ABO

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Paper Abstract

Purpose
Inferior steepening on corneal topography could be an indication of corneal ectasia or contact-lens related corneal warpage. This study adds idiopathic corneal warpage to the differential diagnosis.

Methods
This is a retrospective case series of corneal warpage unrelated to contact lens wear. Corneal and epithelial thickness maps were obtained by a spectral-domain optical coherence tomography (OCT) (Avanti, Optovue, Fremont, CA). Topography maps were obtained by either Scheimpflug imaging (Pentacam HR, Oculus, Arlington, WA) or Placido/scanning-slit topography/tomography (Orbscan II, Bausch & Lomb, Rochester, NY).

Results
Eight eyes of 4 patients that presented with focal inferior topographic steepening were studied. Six eyes had no history of contact lens wear, and 2 eyes had not worn contact lens for at least 3 months. Two eyes had previous LASIK. Keratoconus and post-LASIK ectasia were ruled out by the lack of focal corneal thinning, posterior elevation, and compensatory epithelial thinning at the location of focal steepening. Instead, the steepening was associated with focal epithelial thickening that would be expected of corneal warpage.

Conclusion
These cases represent a previously undescribed entity: idiopathic corneal warpage. The topographic and OCT findings are similar to contact lens-related corneal warpage, but without a history of contact lens wear. Topography and OCT are synergistic tools in differentiating warpage from ectasia, both of which could present with inferior steepening.

Authors

Presenting Author
Priscilla Q. Vu, MD, MS    Email the author
Authors
Winston D. Chamberlain, MD, PhD, ABO, Afshan A. Nanji, MD, MPH, Travis K Redd, MD, MPH, Richard D. Stutzman, MD, ABO

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Paper Abstract

Purpose
Dry eye disease (DED) management is complex, and there are few options for refractory disease. A few studies have shown the benefits of amniotic membrane on DED. Our study aims to evaluate the use and effect of a novel FDA-approved umbilical cord and amniotic membrane allograft (NEOX CORT RT, Amniox, Miami, Florida) on refractory DED.

Methods
This is a retrospective, pilot study of 3 patients with refractory DED that failed standard treatment, including artificial tears, cyclosporine drops, and/or topical steroids. Patients with recent ocular surgery within 3 months, eyelid abnormality, contact lens use, pregnancy, or active eye infection were excluded. The cord tissue was placed into the superior fornix of a randomly selected eye with forceps and left there until dissolved. Pre- and post-treatment best corrected visual acuity (BCVA), fluorescein pattern, and Schirmer test were compared between fellow eyes. DEWS, OSDI, SPEED, and visual analog scale (VAS) pain scores were also compared.

Results
Grafts dissolved by 1 week. There were no complications, complaints of discomfort, or requests for graft removal. By postoperative month 1, mean Schirmer score increased by 2 mm (treated eye) vs 0.7 (untreated eye), tear break up time (TBUT) decreased by 2.7 seconds (treated) vs 2.3 (untreated), DEWS was unchanged (both eyes), OSDI decreased by 2.7 (treated) vs 3.3 (untreated), SPEED decreased by 1 (treated) vs 1.3 (untreated), and BCVA was stable within 1 line (both eyes). VAS score decreased by 2.3 at week 1 and 2 at month 1 (treated) vs 2 at week 1 and 2.6 at month 1 (untreated). NEI scale was the same preoperatively, but better in the treated compared to untreated eye postoperatively.

Conclusion
This is a technically easy procedure with minimal risk and discomfort to patients. There was improvement in mean Schirmer, TBUT and NEI at month 1 that was greater in the treated eye. OSDI, SPEED, and pain improved, but not more than the untreated eye. Further study, larger sample size and masking is needed to determine true efficacy on dry eyes.

Authors

Presenting Author
Jay S. Pepose, MD, PhD, ABO    Email the author
Authors
Robert O Baratta, MD, ABO

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Paper Abstract

Purpose
Is collagen damage common in moderate to severe cases of ocular surface and stromal disease, and would a primary collagen reparative be efficacious in the treatment of such disease.

Methods
A Literature review identified damaged collagen as common in diseases of the corneal epithelium. In vitro studies which defined the structural and the molecular changes which develop in epithelial diseases were followed by studies comparing the effectiveness of collagen mimetic peptides (CMP's) in reversing these changes. In vivo mouse studies of ocular surface and stromal damage with controls were then performed. Gross and histologic results of peptide reparative treated specimens are reported

Results
In vitro results, after a peptide had been applied to collagenase- damaged collagen, showed epithelial cell adherence and regrowth on the damaged collagen (p<.005). In vivo, application of CMPs to mouse eyes immediately after lamellar keratectomy resulted in new epithelial regrowth (p<.001); epithelial cell adherence to Bowman's (p<.002); and epithelial cell morphological regularity (p<.001), reminiscent of those seen in naive mice. Results were confirmed using fluorescence photomicrography and histopathology. Mechanism of action studies of CMP treatment on the cascade of signaling components involved in disease progression in epithelial and stromal tissues are in process.

Conclusion
Collagen mimetic peptides show promise as a potential therapeutic for ocular surface and stromal disease. Further studies and formulation, stability, manufacture, toxicity and pharmacokinetics testing are underway.

Authors

Presenting Author
David Wirta, MD    Email the author
Authors
Paul Karpecki, OD, Smajo Osmanovic, MD

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Paper Abstract

Purpose
To report clinical effect of a single TearCare® (Sight Sciences) procedure in treating the signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD) in adult patients.

Methods
29 subjects (60.6±12.4 yo) received single TearCare treatment & were assessed by a masked assessor at baseline (BL), post-treatment 1week & 1month. Subjects with Ocular Surface Disease Index (OSDI) ≥23 & ≤79 (moderate to severe), Meibomian gland secretion score (MGSS) ≤12, Tear Break-Up time (TBUT) ≤7 & ≥15 expressible glands in lower lid were treated in both eyes. Effectiveness measures included TBUT, OSDI Score, MGSS, corneal & conjunctival staining scores. Adverse events (AE) & changes in visual acuity were used to asses safety. Subgroup analyses were performed in 1)eyes grouped based on severity of MGD: eyes above & below median MGSS, 2)for the subjects with h/o use of DED therapeutics.

Results
TBUT of 3.7±1.1 secs was improved by 2.6±1.6 (70%) secs at 1week & by 3.1±2.2 (84%) secs at 1month (p<0.0001). OSDI of 54.9±20.2 improved by 17.9±20.9 at 1week and 25.8±24.3 at 1month (p<0.001). Clinically meaningful symptom relief, per Miller definition, was seen in 83% & improvement of ≥1 OSDI category was seen in 66% subjects. MGSS of 5.6±4.0 improved by 9.3±4.0 at 1week and 8.8±5.8 at 1month (p<0.0001). Similar trajectories of improvement were observed for subgroups of subjects. Subjects with more severe MGD had greater improvements in signs and symptoms compared to the less severe subgroup. No device-related adverse events or significant changes in visual acuity were observed.

Conclusion
Single TearCare treatment safely achieved significant improvements, within post-treatment 1week, in all DED signs & symptoms for all subjects (100%) treated irrespective of their MGD severity. These results underscore broad-acting effectiveness of TearCare to ameliorate obstructions in MG by effective liquification & evacuation of hardened meibum.

Authors

Presenting Author
Steven L. Carter, MD    Email the author
Authors
Thanh-Thao Vu, MD, Priyanka Chhadva, MD, Priscilla Q. Vu, MD, MS, Urmi V. Mehta, Param Bhatter, Kayla M White, Kailey A. Marshall, OD, Kavita K. Rao, MD, ABO, Marjan Farid, MD, ABO

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Paper Abstract

Purpose
To further understand the association of contact lens use with meibomian gland dysfunction and associated changes on meibography.

Methods
A survey was given as part of standard workup for ocular surface disease at a tertiary academic center. The survey included history of contact lens (CTL) use, type of CTL used, frequency of use, duration of use, and if the patient slept in CTL. Contact lens users were compared to non-contact lens users, and meibomian gland dropout and structural changes as evidenced on meibography was assessed. Subgroup analysis was further used to identify contact lens characteristics associated with meibomian gland dropout.

Results
A total of 189 patients were evaluated with a mean age of 67 years old. There was no significant difference in meibomian gland loss in contact lens users compared to non-contact lens users. Amongst the contact lens users, the type of contact lenses used and frequency of use also did not significantly impact meibomian gland dropout. The duration of contact lens use, with contact lens users of more than 20 years, had more dropout than those with 10-20 years of use (p=0.073) but this did not reach statistical significance. Very few patients reported sleeping in contact lenses (n=3), and there was no significant difference in meiboscores for these patients.

Conclusion
Early evidence revealed a correlation between duration of contact lens use and meibomian gland dropout. However, loss of meibomian glands as we age may also confound these results. To further clarify this potential relationship between CTL wear history and duration with meibomian gland dropout would require a larger controlled study.

Authors

Presenting Author
Ehsan Sadri, MD, FACS    Email the author
Authors
Elizabeth Yeu, MD, William B. Trattler, MD, ABO, Stephanie N Baba, OD, Mark J. Holdbrook

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Paper Abstract

Purpose
To understand the prevalence of collarettes, a pathognomonic clinical sign of Demodex blepharitis, in U.S. eye care clinics today.

Methods
This is a retrospective chart review of consecutive patients evaluated across geographically diverse eye clinics for the presence of collarettes on clinical examination. Factors that will be elucidated from each chart review will include the presence of collarettes, prior diagnosis of Dry Eye Disease, and use of prescription dry eye anti-inflammatories, lifitegrast (LIF) and/or cyclosporine (CSA).

Results
A total of eight eye care specialists participated in this retrospective chart review in which 1121 consecutive patient charts were assessed. The presence of collarettes was observed in 58% of patients (655/1121). It was found that 20% of all patients (221/1121) were using a prescription topical anti-inflammatory (i.e. CSA 0.05% or 0.09%, LIF 5%) and that 22% of patients with collarettes were on CSA or LIF (144/655). Of patients on CSA or LIF, 65% also demonstrated collarettes (144/221).

Conclusion
Collarettes and Demodex blepharitis are commonly seen among patients visiting eye care specialists. Demodex blepharitis can be seen in patients who are using a topical dry eye prescription anti-inflammatory drop. A prospective study is needed to better understand the true prevalence of Demodex blepharitis and collarettes in U.S. eye care clinics.

Authors

Presenting Author
Elizabeth Yeu, MD    Email the author
Authors
David Wirta, MD, Stephanie N Baba, OD, Mark J. Holdbrook

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Paper Abstract

Purpose
Despite the high prevalence of patients with Demodex blepharitis (DB), there are currently no FDA-approved therapeutics for this condition. The purpose of this study was to evaluate the safety and efficacy of TP-03 (lotilaner ophthalmic solution, 0.25%; Tarsus Pharmaceuticals) for the treatment of DB in patients aged 18 or older.

Methods
Randomized, controlled, double-masked study: 421 patients at 15 US sites. Inclusion criteria: At least 1 eye with >10 upper lid collarettes, at least mild lid margin erythema, and ≥1.5 mites/lash on upper and lower lids combined. Patients using lid hygiene or other blepharitis treatment within 14 days were excluded. Dosing: 1 drop of TP-03 or vehicle in each eye BID for 43 days. Primary endpoint: complete collarette cure (CC) defined as 0-2 upper lid collarettes at Day 43 (D43). Secondary endpoints: Demodex mite eradication (ME); and cure based on a composite of upper lid collarette score and erythema score. Clinically meaningful outcomes and responder rates were also recorded.

Results
Values are [TP-03 vs vehicle]. TP-03 demonstrated statistically significant complete CC [43 vs 7%] and clinically meaningful CC of ≤10 collarettes [81 vs 23%] at D43 (p<0.0001). Complete ME was observed at D43 [68 vs 18%] (p<0.0001). Complete and clinically meaningful composite cure [13 vs 1%], [68 vs 20%] was achieved at D43 (p<0.0001). Mean mite density was [0.14±0.25 vs 1.34±1.3] at D43 (p<0.0001). [93 vs 50%] patients improved by at least one collarette grade and [96 vs 36%] achieved a mite density of 0.5 or less (p<0.0001). Patients rated TP-03 as neutral to very comfortable 92% of the time, there were no serious treatment related AEs or treatment discontinuations due to an AE.

Conclusion
TP-03 is a safe and effective treatment for DB. All regulatory and clinically meaningful endpoints of the Saturn-1 study were met w/ high statistical significance. TP-03 treated patients demonstrate collarette and lid erythema reduction and mite eradication. TP-03 has the potential to be the standard of care for patients w/ Demodex blepharitis.

Authors

Presenting Author
Renn Lovett, RN, BSN    Email the author
Authors
Garrett C Nix, Elizabeth L Eshun, Lauren C Ditta, MD, Natalie C. Kerr, MD, FACS, Kourtney H. Houser, MD, ABO

Paper Abstract

Purpose
To evaluate the prevalence of various etiologies of pediatric and adult band keratopathy at one tertiary referral center, and to assess the frequency of relevant comorbidities.

Methods
After Institutional Review Board (IRB) approval, data were collected retrospectively. Adult subjects were identified by searching the electronic medical record (EMR) at our institution for the Current Procedural Terminology (CPT) code for removal of corneal epithelium with application of chelating agent (e.g. EDTA) and the International Classification of Diseases (ICD-10) codes for band keratopathy (BK). Pediatric subjects were identified by searching for ICD-10 codes for BK and for central corneal opacity. Exclusion criteria included lack of definitive BK diagnosis and presentation predating the EMR or after July 2020. Eighteen children and 58 adults met criteria.

Results
6 of 58 adults presented at <18 years of age and were analyzed as children; 4 patients were excluded for lack of data in the EMR. 49 adult patients and 64 eyes were identified. 31% had bilateral BK. Age ranged from 20-96 years old. 55% were female, 45% male. 7 adult patients (14%) had trauma listed for etiology. 5 patients (10%) had silicone oil for etiology. 7 adults (14%) had a multifactorial etiology, and 15 (31%) had an undetermined etiology as documented in the EMR. 23 pediatric patients and 37 eyes were identified. 61% had bilateral BK. Age ranged from 1-16 years old. 11 patients (48%) had BK due to panretinal photocoagulation and cryotherapy for retinopathy of prematurity.

Conclusion
Most adult patients had an etiology that was undetermined or multifactorial, while most pediatric patients had an etiology from treatment of ROP. Knowledge of etiologies may help providers identify patients at greater risk and determine which patients may benefit from further therapy.

Authors

Presenting Author
Joseph Tauber, MD    Email the author
Authors
David Kading, OD, Parag A. Majmudar, MD, Satish S. Modi, FRCS, MD, Julio Echegoyen, MD, PhD, ABO, Bret L. Fisher, MD, ABO, Jason R. Miller, OD, Brennan Greene, MD, ABO, Katherine M. Bickle, OD, MS, Colton M Heinrich, OD, Gina Wesley, OD, Shane R. Kannarr, OD, David J Ludwick, MD, FACS, ABO

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Paper Abstract

Purpose
To demonstrate noninferiority of SYSTANE iLux when compared to LipiFlow in change from baseline in Meibomian Gland Score (MGS) at 12 months post single treatment in MGD subjects with evaporative dry eye disease (EDE).

Methods
This was a prospective, randomized, assessor-masked, parallel group study comparing iLux to LipiFlow in subjects with EDE. Subjects with IDEEL-Symptom Bother module score of > 16, non-invasive tear breakup time score of < 10 seconds and MGS ≤ 12 in lower eyelids were randomized for bilateral treatment in a 1:1 ratio to receive a single treatment with either SYSTANE iLux or LipiFlow. MGS was assessed in the lower eyelid margin. Fifteen glands of the lower lid (3 zones - nasal, temporal, central) were evaluated on each eye. Each gland was graded from 0-3 (45 max score) (0=no secretion, 1=inspissated, 2=cloudy, 3=clear liquid).

Results
Subjects attended 8 visits: Baseline, Treatment, 2-Wk, 1,3,6,9 and 12 Month/Exit. Four interim analyses (IA) were conducted at 1, 3, 6 and 9 Months. At each interim analysis, non-inferiority in change from baseline in MGS with iLux compared to LipiFlow was assessed. Results: Data from 188 treated patients were used for IA. Treatment difference (SYSTANE iLux minus LipiFlow) and the corresponding one-sided 95% lower confidence limit (LCL) was computed. Non-inferiority in change from baseline in MGS was declared if the LCL is greater than -5. Non-inferiority of iLux compared to LipiFlow in change from baseline in MGS was achieved at 1 Month, 3 Months, 6 Months, and 9 Months.

ConclusionThis study demonstrated that SYSTANE iLux is non-inferior to Lipiflow Thermal pulsation system in the change in MGS up to 9 months following a single treatment.

Authors

Presenting Author
Eric D. Donnenfeld, MD    Email the author

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Paper Abstract

Purpose
To assess the efficacy and safety, relative to vehicle, of OCS-02, a new anti-TNFα antibody fragment for topical ocular application, in the relief of persistent ocular discomfort in patients with severe dry eye disease (DED). Systemic exposure, in terms of serum levels, of OCS-02 was also assessed, as were potential biomarkers.

Methods
This was a multicenter, randomized, vehicle-controlled, double masked, prospective study. Entry criteria were ≥6 month history of DED, regular use of artificial tears, gels, lubricants or re-wetting drops, and best-corrected visual acuity (BCVA) ≥55 ETDRS letters in each eye. The population was enriched for severe DED by discontinuing patients who responded to artificial tears or vehicle. Remaining patients were randomized to 3 drops/day OCS-02 (60 mg/mL ophthalmic solution, N = 69) or vehicle (N = 65) for 6 weeks. The primary endpoint was change from baseline in global ocular discomfort score at Day 29. Biomarkers were measured and safety was assessed, including intraocular pressure (IOP).

Results
Change from baseline to Day 29 in global ocular discomfort score was statistically significantly greater for OCS-02 (–7.9) than Vehicle (–3.6, p = 0.041). A statistically significantly greater proportion of patients treated with OCS-02 (17.9%) compared to vehicle (4.7%, p = 0.018) had >20 unit improvement in global ocular discomfort score. A biomarker of increased response, as observed in some patients, was identified and is being further evaluated. No safety issues were identified; IOP changes were minimal with no between-group difference. OCS-02 was undetectable in serum in most patients; the maximum observed concentration was 8.47 ng/mL.

Conclusion
Topical ocular OCS-02 was effective in relieving ocular discomfort in patients with severe DED, with good tolerability, no increase in IOP, and minimal systemic drug exposure. A potential biomarker may help individualize treatment. OCS-02 has the potential to provide an effective, well-tolerated topical treatment for such patients.

★ This paper won Best Paper of Session (BPOS) at the 2021 ASCRS Annual Meeting

Authors

Presenting Author
Eric D. Rosenberg, DO, MSE    Email the author
Authors
Alanna S. Nattis, DO, Vinh Ngo, DO, OD

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Paper Abstract

Purpose
To explore the prevalence of demodicosis in all patients presenting to two large, tertiary care general and subspecialty clinics, and to identify comorbid conditions and risk factors associated with the disease. Lastly, build and design the first demodex algorithm prediction tool.

Methods
A cross-sectional, non-randomized, prospective study investigating the prevalence of Demodex folliculorum (DF) and brevis (DB) in 200 patients recruited from tertiary care outpatient clinics. Epilation of one lash from each lid was performed and studied under high powered light microscopy. Noted was race, age, gender, duration of dry eye blepharitis syndrome (DEBS) (if present), eyedrop use, ocular surgical history, previous treatments aimed at improving DEBS, presence of pterygium, and use of OTC cosmetic products.

Results
Average age for the sample population was 59.3 years, with the presence of blepharitis in 61.8%, DED in 68.3%, and Demodex in over half (55.3%) of individuals sampled. Demodex was prevalent in 45% of those under 50yo, while increasing linearly to 70% in those over 70yo. The presence of Demodex was dependent on age (p=0.003), history of pterygium surgery (p=0.01), dermatochalasis (p=0.001), blepharitis (p<0.001), and DED (p=0.001). Of those patients currently undergoing some form of treatment for DEBS, 55.7% were found to have Demodex, with only 3% undergoing adequate treatment.

Conclusion
Demodex is grossly underdiagnosed and responsible for acute & refractory blepharitis. Strong associations were noted between DED, blepharitis, and dermatochalasis, while alpha agonists appeared to have a protective effect. We present the first ever prediction tool to predict the presence of demodex.

Authors

Presenting Author
Melissa M. Toyos, MD, FACS    Email the author
Authors
Rolando Toyos, MD, ABO

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Paper Abstract

Purpose
To investigate the clinical safety and efficacy of subcutaneouos HP Acthar gel as adjunctive treatment in subjects with moderate to severe dry eye disease unresponsive or incompletely treated with traditional medications.

Methods
Twelve subjects with moderate to severe dry eye uncontrolled on stable doses of standard dry eye treatments received 40-80 units of HP Acthar Gel IM or SC for 12 weeks. Subject evaluations included subject rated assessment of ocular discomfort, erythema, best corrected visual acuity, corneal and conjunctival staining and intraocular pressure. subjects with a history of ocular or systemic viral, fungal disease or tuberculosis, scleroderma, those who were immunocompromised or with uncontrolled cardiac disease, uncontrolled hypertension or diabetes and those with active peptic ulcer disease, cirrhosisor thyroid disease were excluded.

Results
At 80 units given twice weekly, SANDE scores declined fom 69 at baseline to 44 at final visit (p=0.02), corneal fluorescein score reduction and Schirmer's testing both improved with p<0.08. Erythema reduction was statistically significant at p<0.001 and conjunctival lissamine green staining and intraocular pressure measurements (avg decrease in iop 2 mm Hg) showed downward trends but not statistically significant. Time to response was 14 d for SANDE and 7 days for k and conj staining. BCVA was stable. No ocular adverse events occurred. One serious adverse event occurred (arrythmia) in a patient with a history of controlled cardiac arrhythmia and drug relation could not be ruled out.

Conclusion