cyclosporine ophthalmic emulsion / Generic mfg. 
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  • ||||||||||  ciclosporine/trehalose (HU007) / Huons
    Trial completion, Head-to-Head:  Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome (clinicaltrials.gov) -  May 7, 2020   
    P3,  N=209, Completed, 
    The study also suggests that the different anti-inflammatory eye drops modulated inflammatory genes in a slightly different manner. Enrolling by invitation --> Completed
  • ||||||||||  Xiidra (lifitegrast) / Novartis, cyclosporine / Generic mfg., cyclosporine ophthalmic emulsion / Generic mfg.
    Journal:  Physician Satisfaction with Anti-Inflammatory Topical Medications for the Treatment of Dry Eye Disease. (Pubmed Central) -  Apr 11, 2020   
    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.
  • ||||||||||  cyclosporin A microemulsion / Generic mfg., cyclosporine / Generic mfg.
    Review, Journal:  Recent advances in cyclosporine drug delivery: challenges and opportunities. (Pubmed Central) -  Apr 2, 2020   
    Although these recent advances in cyclosporine delivery look promising, its clinical translation require in depth studies to deliver safe, efficacious, and stable formulation of cyclosporine. This review focuses on challenges of cyclosporine delivery and the recent advancements for overcoming the constraints.
  • ||||||||||  cyclosporine ophthalmic emulsion / Generic mfg.
    Xanthohumol protects corneal epithelial cells in experimental models for dry-eye disease (Exhibit Hall: Posterboard# A0356) -  Mar 9, 2020 - Abstract #ARVO2020ARVO_3879;    
    Ophthalmic cyclosporine (0.05%; formulated as Restasis®, Allergan plc., Irvine, CA) was administered twice daily and used as positive control for the assay.Results Xn exerted a statistically significant dose-dependent protection of HCE-T cells against tBHP-induced oxidative stress...Xn had no effects on tear volume (P = 0.35).Conclusions Xn exerts cytoprotective effects against oxidative stress in human corneal epithelial cells and can improve corneal surface damage from desiccating stress/ scopolamine administration. PLGA NP represent a safe and efficacious formulation for hydrophobic compounds.
  • ||||||||||  cyclosporine ophthalmic emulsion / Generic mfg.
    Novel Eye Drops for the Treatment of Dry Eye Disease (Exhibit Hall: Posterboard# A0144) -  Mar 9, 2020 - Abstract #ARVO2020ARVO_3485;    
    We have demonstrated in animal models that our eye drops are as effective as the market leading product, Restasis, when given once every three days compared to Restasis' required dosing of twice daily. This new formulation would be more convenient and efficacious for patients suffering from Dry Eye Disease.
  • ||||||||||  cyclosporine ophthalmic emulsion / Generic mfg.
    Comparison of Cellular Cytotoxicity Induced by Dry Eye Conditions by Formulations of Cyclosporine. (Exhibit Hall: Posterboard# A0129) -  Mar 9, 2020 - Abstract #ARVO2020ARVO_361;    
    Restasis® and emulsions containing CysA also reduced cellular toxicity.Conclusions The results of these experiments can be used for future in vitro drug development studies as a benchmark for the efficacy of Restasis®. Moreover, these data support new avenues for the study of the efficacy of alternative castor-oil nanoemulsions in conditions mimicking DED.
  • ||||||||||  cyclosporine ophthalmic emulsion / Generic mfg.
    Effect of cyclosporine ophthalmic solution 0.09% on conjunctival staining in patients with keratoconjunctivitis sicca (Exhibit Hall: Posterboard# A0097) -  Mar 9, 2020 - Abstract #ARVO2020ARVO_328;    
    Pooled safety analysis (n = 524 per arm) showed most AEs were mild; instillation site pain was most common AE (21.8% vs 4.0% for OTX-101 and vehicle, respectively).Conclusions OTX-101 0.09% significantly improved conjunctival surface integrity in patients with KCS, with a difference seen as early as day 28 (zones 3 and 5) and day 56 (zone 1) in 3 of the 4 individual zones. OTX-101 0.09% was well tolerated.
  • ||||||||||  cyclosporine ophthalmic emulsion / Generic mfg.
    An evaluation of cyclosporine ophthalmic solution 0.09% vs cyclosporine ophthalmic emulsion 0.05% on tear volume in an NOD mice model (Exhibit Hall: Posterboard# A0087) -  Mar 9, 2020 - Abstract #ARVO2020ARVO_318;    
    OTX-101 BID significantly improved tear production mean change from baseline (SD) vs reference at days 45 and 60; 6.5 (3.6) vs 2.3 (3.7), and 7.9 (4.3) vs 4.1 (2.7), respectively (P <0.01 for both). Both OTX-101 QD and OTX-101 BID significantly improved tear production at day 60 vs placebo (P <0.01 and P <0.001, respectively).Conclusions OTX-101 BID 0.09% led to superior changes from baseline in tear volume vs cyclosporine ophthalmic emulsion 0.05% and placebo through 60 days of treatment in NOD mice demonstrating tear production deficiency and dry eye phenotype.
  • ||||||||||  Xiidra (lifitegrast) / Novartis, cyclosporine / Generic mfg.
    Prevalence of Artificial Tear Use with Cyclosporine or Lifitegrast: An AAO IRIS Registry Analysis (BCEC-Meeting Level 1,Room 152) -  Mar 1, 2020 - Abstract #ASCRSASOA2020ASCRS-ASOA_1146;    
    Conclusion Approximately one-third of patients prescribed either CsA or lifitegrast for dry eye disease were using artificial tears concurrently. Approximately half of patients using CsA or lifitegrast had a diagnosis of MGD.
  • ||||||||||  cyclosporin A microemulsion / Generic mfg., cyclosporine ophthalmic emulsion / Generic mfg.
    Trial termination:  CsA: The Effects of Cyclosporin A in a Low Humidity Environment, on the Ocular Surface (clinicaltrials.gov) -  Feb 23, 2020   
    P=N/A,  N=4, Terminated, 
    This study should help surgeons in deciding which LVC surgery to recommend in order to reduce postoperative dry eye incidence and improve overall patient quality of life. Completed --> Terminated; Funding was terminated
  • ||||||||||  cyclosporin A microemulsion / Generic mfg., cyclosporine ophthalmic emulsion / Generic mfg.
    Enrollment change:  CsA: The Effects of Cyclosporin A in a Low Humidity Environment, on the Ocular Surface (clinicaltrials.gov) -  Feb 5, 2020   
    P=N/A,  N=4, Completed, 
    With further improvements, the modeling framework developed for this study may be useful for informing future recommendations of cyclosporine ophthalmic emulsion bioequivalence for potential generic drug products. N=20 --> 4
  • ||||||||||  Review, Journal:  Drugs for common eye disorders. (Pubmed Central) -  Dec 22, 2019   
    These findings highlight the continued importance of research and therapeutic development for this common condition. No abstract available
  • ||||||||||  Xiidra (lifitegrast) / Novartis, cyclosporine / Generic mfg., cyclosporine ophthalmic emulsion / Generic mfg.
    Clinical, Journal, HEOR, Real-World Evidence:  Real-World Treatment Patterns Of Cyclosporine Ophthalmic Emulsion And Lifitegrast Ophthalmic Solution Among Patients With Dry Eye. (Pubmed Central) -  Dec 12, 2019   
    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.
  • ||||||||||  cyclosporine / generics, cyclosporine ophthalmic emulsion / generics
    Clinical, Journal:  Comorbidities and Prescribed Medications in Patients With or Without Dry Eye Disease: A Population-Based Study. (Pubmed Central) -  Nov 23, 2019   
    The results of an in vivo dry eye mouse model demonstrated that a 100-fold lower dose of the CsA/LK-3 complex than that of Restasis® is sufficient to cause the same therapeutic effect. The high proportions of patients with DED with a range of comorbidities and prescribed medications highlight the need for a multidisciplinary approach to the management of these patients.
  • ||||||||||  Cequa (nanomicellar cyclosporine) / Sun Pharma
    Journal:  Cyclosporine 0.09% solution (Cequa) for dry eye Disease. (Pubmed Central) -  Nov 13, 2019   
    The high proportions of patients with DED with a range of comorbidities and prescribed medications highlight the need for a multidisciplinary approach to the management of these patients. No abstract available
  • ||||||||||  cyclosporine / generics
    Biomarker, Review, Journal:  Topical cyclosporine A therapy for dry eye syndrome. (Pubmed Central) -  Oct 18, 2019   
    Well-planned, long-term, large clinical trials are needed to better assess CsA on long-term dry eye-modifying effects. A core outcome set, which ideally includes both biomarkers and patient-reported outcomes in the field of dry eye, is needed.
  • ||||||||||  cyclosporine / generics, cyclosporine ophthalmic emulsion / generics
    Journal:  Practical guidance for the use of cyclosporine ophthalmic solutions in the management of dry eye disease. (Pubmed Central) -  Jul 18, 2019   
    It is well established that ocular surface inflammation has an important role in the pathophysiology of DED and that anti-inflammatory cyclosporine A (CsA) improves the treatment outcomes of most patients with DED. The purpose of this review is to provide guidance for practitioners in the use of topical CsA for the management of DED to improve patient satisfaction and the quality of life.
  • ||||||||||  Xiidra (lifitegrast) / Takeda
    Clinical, Journal:  Evaluating Patient Experiences in Dry Eye Disease Through Social Media Listening Research. (Pubmed Central) -  Jun 6, 2019   
    Insights revealed using SML strengthen our understanding about patient experiences and their unmet needs in DED. This study illustrates that an SML approach contributed effectively in generating patient insights, which can be utilised to inform early drug development process, market access strategies and stakeholder discussions.