Perfluorohexyloctane ophthalmic solution (PFHO) is indicated for the treatment of signs and symptoms of dry eye disease (DED) and targets excessive tear evaporation. This study evaluated patient-reported outcomes early in treatment with PFHO. This prospective, multicenter, open-label, phase 4 study enrolled adults with a history of DED for ≥ 6 months. PFHO was instilled in both eyes four times daily for 14 days. Patients completed early outcome surveys during four clinic visits (day 1 [pretreatment; 5 and 60 min post-PFHO instillation] and days 3, 7, and 14). Symptom severity, symptom frequency, and treatment satisfaction were rated on visual analog scales (range 0–100). The primary endpoint was mean change from baseline in overall DED symptom severity at day 7. Secondary endpoints included change in severity of individual DED symptoms (eye dryness, blurred vision, eye irritation, light sensitivity, eye tiredness, burning/stinging, eye itching, eye pain); change in frequency (measured as percentage of time experienced) of the most bothersome symptom, awareness of dry eye symptoms, and fluctuation in quality of vision; and treatment satisfaction. Ninety-nine patients enrolled (85.9

Purpose: To study the association between tear film hyperosmolarity and ocular light scatter in a cataract surgery population. Patients and Methods: Contiguous, 20-second objective scatter index (OSI) scans were recorded in hyperosmolar (>= 320 mOsm/L) and normal subjects (< 308 mOsm/L) with cataract nuclear opacity >= 3. OSI was measured at screening, baseline and 90 days following surgery. Along with symptoms of ocular surface disease, slit-lamp examination included corneal staining (0- 3), tear film breakup time (TBUT) and evaluation of meibomian gland disease (MGD). An additional cohort of hyperosmolar subjects were measured for OSI at screening, baseline, and 5, 10, 15 and 30 minutes following instillation of 0.18% sodium hyaluronate (HA). Results: Thirty-one eyes of 31 patients were included. There was a significant difference in post-operative OSI variation when comparing hyperosmolar (0.65 +/- 0.30, N=11) to normal subjects (0.33 +/- 0.11, N=10, p=0.005). Of note, there were no significant differences in OSI variation when subjects were sorted by staining (p=0.9), TBUT (p=0.7), symptoms (p=0.7), or MGD status (p=0.9). Instillation of 0.18% HA (N=10) did not alter OSI at 5 minutes, but significant reductions in OSI of 28.8%, 38.5% and 36.7% (all p < 0.001) were observed at 10, 15 and 30 minutes. Conclusion: Hyperosmolar patients exhibited significantly increased variation in light scatter following cataract surgery that was undifferentiated by staining or TBUT. Elevated osmolarity may be indicative of light scatter equivalent to that of a grade 2- 3 cataract.

BACKGROUND: Matching-adjusted indirect comparison (MAIC) is a methodology for cross-study comparisons after adjusting for baseline characteristic imbalances. It is a comparative analytical approach used across therapeutic areas absent head-to-head trial outcomes. OBJECTIVE: To compare the efficacy of OC-01 (varenicline solution) 0.03 mg nasal spray (OC-01 VNS) to lifitegrast 5% ophthalmic solution on tear production and patient-reported eye dryness in patients with dry eye disease (DED) using data from phase 3 clinical trials via MAIC analysis. METHODS: Individual patient data (IPD) from the phase 3 registrational trial of OC-01 VNS and aggregate data from 2 phase 3 trials of lifitegrast in the publicly available XIIDRA New Drug Application were used. Using unanchored MAIC methods, IPD were weighted on clinically relevant baseline variables (age, race, sex, baseline Schirmer’s test score [STS], and Eye Dryness Score [EDS]) to produce weighted OC-01 VNS datasets matched to the same lifitegrast datasets’ variables. Least-squares (LS) mean change from baseline (CFB) in STS for OC-01 VNS was calculated using the identical analysis of covariance model and covariates used to calculate the same values for lifitegrast in the XIIDRA New Drug Application and was then compared. LS mean EDS (based on a 100- point Visual Analogue Scale) was compared via analysis of covariance in the weighted OC-01 VNS and lifitegrast datasets. OC-01 VNS at 2 and 4 weeks compared to lifitegrast data at 2 and 6 weeks. RESULTS: Data from 511 subjects (n = 260 treated; 251 vehicle control [VC]) in the OC-01 VNS phase 3 trial, 588 (n = 293 treated, 295 VC) in the lifitegrast phase 3 OPUS-1 trial, and 718 (n = 358 treated, 360 VC) in the lifitegrast phase 3 OPUS-2 trial were analyzed. The LS mean STS CFB for OC-01 VNS at 2 and 4 weeks was significantly greater than that for lifitegrast at 2 and 6 weeks in OPUS-1 and OPUS-2 (P < 0.0001 for all comparisons). The LS mean EDS CFB for OC-01 VNS at 2 and 4 weeks was significantly greater than that for lifitegrast at 2 and 6 weeks in OPUS-1 (P < 0.0001 for both comparisons) and at 4 weeks vs lifitegrast at 6 weeks in OPUS-2 (P < 0.0001). CONCLUSIONS: This MAIC analysis demonstrates OC-01 VNS produced significantly greater improvement in mean STS and comparable or greater improvement in EDS compared with lifitegrast in phase 3 trials. These findings suggest a potentially greater magnitude of improvement achieved with OC-01 VNS compared with lifitegrast for the treatment of DED within the conditions of the analysis methodology. DISCLOSURES D White is a consultant for Oyster Point Pharma, Inc. L Hendrix, M Macsai, and A Gibson are employees and shareholders for Oyster Point Pharma, Inc. L Sun was an employee of COEUS, Clinical Research at the time of study conduct and received funding from Oyster Point Pharma, Inc. I Tam is an employee of COEUS, Clinical Research and received funding from Oyster Point Pharma, Inc. Oyster Point Pharma, Inc was involved in the study design, data collection, data analysis, and preparation of the manuscript and is the manufacturer/licensee of OC-01 (varenicline solution) nasal spray. Oyster Point Pharma, Inc., sponsored the phase 3 OC-01 (varenicline solution) clinical study from which analysis data were obtained.

Purpose: Dry eye disease (DED) is one of the most common ophthalmic disorders. Pathogenesis of the disease includes inflammation of the ocular surface and lacrimal gland. Two anti-inflammatory prescription treatments are currently available: cyclosporine ophthalmic emulsion 0.05% (CYC) and lifitegrast 5% ophthalmic solution (LIF). The objective of this survey-based study was to assess physician satisfaction with CYC and LIF for the treatment of DED. Methods: Physicians currently treating DED patients with CYC or LIF were asked to rate the experiences of their patients currently or formerly using CYC and LIF, and their own perspectives on the two treatments. Results: Twenty-one physicians participated in the survey, providing responses on behalf of 210 patients. Overall, physicians reported low levels of satisfaction with onset of action of CYC and LIF, and fewer than half considered either drug to be effective in managing symptoms or improving patient quality of life (QoL). Burning sensation and dysgeusia were the most frequently reported side effects. Onset of action and effectiveness after onset were the main switching drivers. Although two-thirds of physicians were satisfied with the overall effectiveness of CYC and LIF, all physicians agreed that more DED treatment options are needed, with >50% strongly agreeing. Conclusion: Physicians perceived a gap in DED management with currently available topical anti-inflammatory agents. Although satisfaction with CYC and LIF was high, few physicians considered these medications to be effective in managing symptoms or improving QoL.

PURPOSE:To assess patient satisfaction among current and former users of the anti-inflammatory topical medications, cyclosporine A 0.05% (CYC) and lifitegrast 5.0% (LIF), for the management of dry eye disease (DED).PATIENTS AND METHODS:Patients with DED were recruited via physician referral to participate in a survey. Current users of CYC or LIF were asked to rate their experience in terms of satisfaction, side effects, and limitation of activities. Switchers of CYC to LIF or LIF to CYC were asked to rate the importance of potential reasons for switching.RESULTS:Surveys were completed by 207 patients currently treated with CYC (n=98), LIF (n=96), or other DED medications (n=13). Although overall satisfaction with current treatment was high, current users of CYC and LIF reported ineffective relief of DED symptoms (31% and 22%, respectively) and dissatisfaction with the time to onset of effect (29% and 11%). Substantial proportions of patients reported 'sometimes', "usually", or 'always' experiencing the following side effects: burning sensation (72% CYC, 64% LIF), itching (43% CYC, 44% LIF), altered sensation of taste (21% CYC, 56% LIF), blurred vision (37% CYC, 50% LIF), and discharge (28% CYC, 30% LIF). Of the 30 switchers of CYC to LIF and 31 switchers of LIF to CYC, the majority reported inability to relieve DED symptoms as a very or extremely important switching reason. Despite switching, one in four patients were somewhat dissatisfied or dissatisfied with their current medication, with 37% of patients reporting ineffective symptom relief.CONCLUSION:Although the rate of overall satisfaction was generally high with both LIF and CYC, many patients were unable to achieve effective symptom relief and commonly experienced side effects. The proportion of patients who were dissatisfied and/or unable to achieve effective symptom relief even after switching suggests the need for additional treatment options for managing DED.

Darrell E White Yang Zhao Abayomi Ogundele Nicole Fulcher Annabel Acs Laura Moore-Schiltz Paul M Karpecki 1Department of Ophthalmology, SkyVision Centers, Westlake, OH 44145, USA; 2Health Economics and Outcomes Research, Sun Pharmaceutical Industries, Princeton, NJ 08540, USA; 3Outcomes Research, IBM Watson Health, Cambridge, MA 02142, USA; 4Corneal Services and Advanced OSD Clinic, University of Pikeville Kentucky College of Optometry, Pikeville, KY 41501, USA Purpose: To assess adherence, non-persistence, discontinuation, and switching of topical cyclosporine ophthalmic emulsion 0.05% (CYC) and lifitegrast ophthalmic solution 5% (LIF) use in the real world among patients with dry eye disease (DED). Design: Retrospective insurance claims study. Methods: Adult patients with DED and ≥1 prescription claim for CYC or LIF (first claim = index date) in the IBM MarketScan databases from July 2016 to February 2018 were identified. Eligible patients had continuous medical and pharmacy benefits in the 12 months preand post-index periods, and no prior use of the index medication. The proportion of days covered (PDC), adherence, non-persistence, discontinuation, and switching were examined over the 12-month post-index period. Results: This study included 6537 CYC and 3235 LIF patients. The adherence rate was 5.9% for CYC and 9.7% for LIF; the median PDC was 0.3 for both cohorts. Overall, 70.8% of CYC and 64.4% of LIF patients discontinued treatment with median days to discontinuation of 89 and 29, respectively. Non-persistence was 7.1% for CYC and 6.8% for LIF (median days to discontinuation: 89 and 105). In addition, 5.0% switched from CYC to LIF, and 9.6% switched from LIF to CYC over the post-index period. Conclusion: Over 60% of DED patients discontinued treatment within 12 months of initiation; the median time to discontinuation was 3 months for CYC and 1 month for LIF. Although this analysis did not capture the reasons why patients discontinued treatment, the results demonstrate there likely exists a significant unmet need amongst DED patients.

Elizabeth Yeu Damien F Goldberg Francis S Mah Kenneth A Beckman Jodi I Luchs Jonathan D Solomon Darrell E White Preeya K Gupta 1Eastern Virginia Medical School, Virginia Eye Consultants, Norfolk, VA, USA; 2Wolstan & Goldberg Eye Associates, Torrance, CA, USA; 3Scripps Clinic Torrey Pines, La Jolla, CA, USA; 4Ohio State University, Columbus, OH, USA; 5Comprehensive Eye Care of Central Ohio, Westerville, OH, USA; 6Hofstra Northwell School of Medicine, Hempstead, NY, USA; 7South Shore Eye Care, Wantagh, NY, USA; 8Bowie Vision Institute, Bowie, MD, USA; 9Skyvision Centers, Westlake, OH, USA; 10Duke University Eye Center, Durham, NC, USA Purpose: Evaluate the safety and efficacy of cryopreserved amniotic cytokine extract (ACE) in the treatment of subjects with dry eye disease (DED). Patients and methods: This was a retrospective, multicenter, chart review of adult patients with DED that instilled cryopreserved ACE drops twice-daily for 4 or 12 weeks. Patients had corneal fluorescein staining (0–20 range) and/or a lissamine green conjunctival staining score (0–18 range) of ≥3 and ≤9 in at least 1 eye and a score ≥40 (0–100 range) of eye dryness/irritation on a visual analog scale (VAS). Following completion of a treatment course, medical records were reviewed from the initiation of therapy (baseline), and at posttreatment visits (4 weeks, 8 weeks, and 12 weeks). Patient records for visual acuity, adverse events, corneal fluorescein staining, conjunctival lissamine green staining, and symptom scores of ocular dryness/irritation were reviewed for each visit, as available. Safety and tolerability were assessed through the evaluation of patient-reported adverse events recorded in the medical records. Results: A total of 54 eligible patients were identified at 7 clinical sites; 16 patients administered ACE drops for 4-weeks, and 38 patients instilled ACE drops for 12 weeks. Significant improvements in the mean changes from baseline were observed for corneal fluorescein staining, lissamine green staining, visual acuity (LogMar) and VAS ocular symptom scores at the 4-week post-treatment visit (p<0.01). Additional improvements continued out to the 12-week follow-up assessment visits. Two patients discontinued therapy due to reports of ocular burning or foreign body sensation. Conclusion: The cryopreserved ACE formulation was well-tolerated and effective in reducing the clinical signs and symptoms of DED. Conduct of a vehicle-controlled prospective study is warranted.

Purpose: Evaluate the safety and efficacy of cryopreserved amniotic cytokine extract (ACE) in the treatment of subjects with dry eye disease (DED). Patients and methods: This was a retrospective, multicenter, chart review of adult patients with DED that instilled cryopreserved ACE drops twice-daily for 4 or 12 weeks. Patients had corneal fluorescein staining (0–20 range) and/or a lissamine green conjunctival staining score (0–18 range) of ≥3 and ≤9 in at least 1 eye and a score ≥40 (0–100 range) of eye dryness/irritation on a visual analog scale (VAS). Following completion of a treatment course, medical records were reviewed from the initiation of therapy (baseline), and at post-treatment visits (4 weeks, 8 weeks, and 12 weeks). Patient records for visual acuity, adverse events, corneal fluorescein staining, conjunctival lissamine green staining, and symptom scores of ocular dryness/irritation were reviewed for each visit, as available. Safety and tolerability were assessed through the evaluation of patient-reported adverse events recorded in the medical records. Results: A total of 54 eligible patients were identified at 7 clinical sites; 16 patients administered ACE drops for 4-weeks, and 38 patients instilled ACE drops for 12 weeks. Significant improvements in the mean changes from baseline were observed for corneal fluorescein staining, lissamine green staining, visual acuity (LogMar) and VAS ocular symptom scores at the 4-week post-treatment visit (p<0.01). Additional improvements continued out to the 12-week follow-up assessment visits. Two patients discontinued therapy due to reports of ocular burning or foreign body sensation. Conclusion: The cryopreserved ACE formulation was well-tolerated and effective in reducing the clinical signs and symptoms of DED. Conduct of a vehicle-controlled prospective study is warranted.

PURPOSE:To assess adherence, non-persistence, discontinuation, and switching of topical cyclosporine ophthalmic emulsion 0.05% (CYC) and lifitegrast ophthalmic solution 5% (LIF) use in the real world among patients with dry eye disease (DED).DESIGN:Retrospective insurance claims study.METHODS:Adult patients with DED and ≥1 prescription claim for CYC or LIF (first claim = index date) in the IBM® MarketScan® databases from July 2016 to February 2018 were identified. Eligible patients had continuous medical and pharmacy benefits in the 12 months pre- and post-index periods, and no prior use of the index medication. The proportion of days covered (PDC), adherence, non-persistence, discontinuation, and switching were examined over the 12-month post-index period.RESULTS:This study included 6537 CYC and 3235 LIF patients. The adherence rate was 5.9% for CYC and 9.7% for LIF; the median PDC was 0.3 for both cohorts. Overall, 70.8% of CYC and 64.4% of LIF patients discontinued treatment with median days to discontinuation of 89 and 29, respectively. Non-persistence was 7.1% for CYC and 6.8% for LIF (median days to discontinuation: 89 and 105). In addition, 5.0% switched from CYC to LIF, and 9.6% switched from LIF to CYC over the post-index period.CONCLUSION:Over 60% of DED patients discontinued treatment within 12 months of initiation; the median time to discontinuation was 3 months for CYC and 1 month for LIF. Although this analysis did not capture the reasons why patients discontinued treatment, the results demonstrate there likely exists a significant unmet need amongst DED patients.