Cequa (nanomicellar cyclosporine) / Sun Pharma, China Medical System - LARVOL DELTA

Safety and Efficacy of Nanomicellar 0.09% Cyclosporine for Treatment of Dry Eye Disease Refractory to 0.05% Cyclosporine Emulsion: A Single-Arm Prospective Switch Study. (PubMed, Cornea) - "Nanomicellar 0.09% cyclosporine is safe and effective in managing DED in patients with symptoms refractory to 0.05% cyclosporine emulsion."

Journal • Dry Eye Disease • Ophthalmology

Nanotechnological Advances in Ocular Therapeutics: A Narrative Review of Drug Delivery Platforms, Clinical Applications, and Translational Challenges. (PubMed, Nanotechnol Sci Appl) - "Clinically translated examples include cyclosporine A nanomicelle and nanoemulsion formulations, marketed as Cequa (0.09%), Restasis (0.05%), and Ikervis (0.1%), approved for dry eye disease, and a subconjunctival PLGA nanoparticle depot that achieved greater than 20% intraocular pressure reduction sustained over 90 days from a single injection in early clinical evaluation. Lipid-based and polymeric nanocarrier platforms are currently closest to clinical translation, with approved formulations and early-phase trial data supporting meaningful therapeutic advantages over conventional delivery. Realising the full potential of ocular nanomedicine will require addressing residual challenges in long-term ocular safety, manufacturing scalability, and regulatory compliance, particularly for posterior-segment applications, where non-invasive topical delivery remains largely at the preclinical stage."

Journal • Review • Age-related Macular Degeneration • Conjunctivitis • Diabetic Retinopathy • Dry Eye Disease • Eye Cancer • Glaucoma • Inflammation • Keratitis • Macular Degeneration • Ocular Infections • Ocular Inflammation • Oncology • Ophthalmology • Retinal Disorders • Retinoblastoma • Retinopathy of Prematurity • Solid Tumor

Biomimetic Multimodal Evaluation Reveals Enhanced Efficacy and Safety of Cyclosporine A Nanomicelles (CycloNex) for Advanced Dry Eye Management. (PubMed, Small) - "In vivo studies confirmed NMP188-CsA's superior bioavailability, and corneal repair was completed within 14 days in mice with benzalkonium chloride-induced dry eye. These findings, validated through six complementary biological models-including HET-CAM irritation scoring (0.89 vs. Cequa's 1.34)-establish a new paradigm for ocular nanotherapeutic evaluation while demonstrating clinically translatable advantages over current standards."

Journal • Dry Eye Disease • Ophthalmology • TNFA

Cyclosporin (0.09%) Ophthalmic Solution for the Treatment of Dry Eye Disease - A Narrative Review. (PubMed, Curr Eye Res) - "Cyclosporine A (CsA) is an immunomodulatory agent that reduces ocular surface inflammation by inhibiting calcineurin, thereby suppressing T-cell activation...Relevant preclinical and clinical studies of the aqueous nanomicellar formulation of CsA 0.09% (OTX-101 0.09%) were reviewed...Clinical studies have demonstrated that nanomicellar CsA 0.09% therapy significantly improves both signs and symptoms of DED, supporting its utility as an effective and well-tolerated treatment option. Nanomicellar CsA 0.09% therapy significantly improves both signs and symptoms of DED, supporting its utility as an effective and well-tolerated treatment option."

Journal • Review • Conjunctivitis • Dry Eye Disease • Inflammation • Ocular Infections • Ocular Inflammation • Oncology • Ophthalmology • Sjogren's Syndrome • TNFA

Effects of Treatment With Cyclosporine Ophthalmic Solution 0.09% on Dry Eye Questionnaire Scores Among Patients With Dry Eye Disease. (PubMed, Cureus) - "Conclusions CsA 0.09% was well tolerated and led to significant improvements in DEQ-5 scores, reflecting better management of DED symptoms at one, three, and six months of treatment. These results highlight the potential of CsA 0.09% as a long-term treatment option for moderate to severe DED."

Journal • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome

Effect of Cyclosporine Ophthalmic Solution 0.09% on Signs and Symptoms of Dry Dye Disease in Patients Inadequately Controlled on Cyclosporine Ophthalmic Emulsion 0.05%: Results from a Single-Arm, Open-Label, Phase 4 Study. (PubMed, Clin Ophthalmol) - "Overall, CsA 0.09% was well tolerated. The findings from this study suggest that switching from CsA 0.05% to CsA 0.09% may improve signs and symptoms in patients with DED."

Journal • P4 data • Dry Eye Disease • Ophthalmology

Combination of 0.09% cyclosporine and intense pulsed light (IPL) therapy for the treatment of dry eye disease in symptomatic contact lens wearers: study protocol for a sham-controlled randomized clinical trial. (PubMed, Trials) - P3 | "This study aims to test whether a combination of novel dry eye treatments that target the whole tear film improves comfort while wearing contact lenses. Discomfort is a major issue that leads to drop out. The results of this study could provide eyecare professionals with additional tools to help their patients and could open the discussion on future solutions to improve contact lens users' experience."

Clinical • Journal • Dry Eye Disease • Ophthalmology

Effect of OTX-101 0.09% ciclosporin solution on clinical signs of dry eye disease in patients with moderate-to-severe corneal damage: a post-hoc analysis of randomized clinical trials. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "Administration of OTX-101 0.09% leads to statistically significant improvement across six parameters in ocular surface staining and tear production in DED patients with moderate to severe corneal damage."

Clinical • Journal • Retrospective data • Anesthesia • Conjunctivitis • Corneal Abrasion • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome

Acoltremon (Tryptyr) for dry eye disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dry Eye Disease • Ophthalmology

The Role of Topical Cyclosporine A in Ocular Surface Inflammatory Disorders. (PubMed, Semin Ophthalmol) - " After carrying out a literature search on "Cyclosporine A", "Ocular surface disease", "Dry eye", "Vernal keratoconjunctivitis", "Graft versus host disease", "Restasis", "Cequa", "Vevye", "Ikervis", a total of 101 articles were included for this review.  Topical CsA remains a cornerstone therapy in the management of OSID, providing long-term inflammation control, improved ocular surface integrity, and symptomatic relief. Continued research into optimized formulations, combination therapies, and alternative delivery systems may further refine its clinical utility and enhance patient adherence."

Journal • Review • Conjunctivitis • Dry Eye Disease • Graft versus Host Disease • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome • Transplant Rejection • Transplantation

Cyclosporine Solution 0.09% Boosts Outcomes in Uncontrolled Dry Eye (HCPLive) - P4 | N=135 | NCT04357795 | Sponsor: Sun Pharmaceutical Industries Limited | "A subgroup analysis of a Phase 4, open-label, single-arm, multicenter study demonstrated the benefit of cyclosporine (CsA) ophthalmic solution 0.09% (CEQUA) for patients with dry eye disease (DED) uncontrolled on CsA ophthalmic emulsion 0.05% (Restasis)...Presented at the 2025 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting....The mean baseline mSANDE scores were 63.2 and 70.5 for those above and below the median age, respectively, and 75.8 and 65.9 for males and females, respectively. The analysis found the mean changes from baseline in CFS and mSANDE scores significant at Weeks 4, 8, and 12, irrespective of age (P <.0001) and sex (P ≤.0473)."

P4 data • Dry Eye Disease

Effects of nanomicellular cyclosporine ophthalmic solution 0.09% on dry eye findings associated with Sjogren's Syndrome (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Dry Eye Disease • Keratitis • Ocular Inflammation • Ophthalmology

The combination of 0.09% cyclosporine and IPL therapy for the treatment of dry eye disease in symptomatic contact lens wearers: a sham-controlled randomized clinical trial: preliminary results (ARVO 2025) - "This is a clinical trial testing the effects of a combination of 0.09% nanomicellar cyclosporin drop (Cequa, Sun Pharma) and intense pulsed light (IPL) treatment on the symptoms and signs of dry eye in soft contact lens (SCL) wearers...The second one is intense pulsed light, which is a treatment done in clinic that helps the glands of the eyelids produce better oil for the tears.This combination has never been tried in a controlled study to test its effect on contact lens wearers. The study is ongoing, and the results presented here are preliminary and only is on a fraction of the total sample with only the first treatment having been performed so far."

Clinical • Conjunctivitis • Dry Eye Disease • Glaucoma • Ocular Infections • Ocular Inflammation • Ophthalmology

Drugs for dry eye disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dry Eye Disease • Ophthalmology

Quintessence of currently approved and upcoming treatments for dry eye disease. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "Currently, the US Food and Drug Administration (FDA)-approved medical treatments for treatment of DED include cyclosporine formulations (RESTASIS® [cyclosporine 0.05% ophthalmic emulsion], VEVYE® [cyclosporine 0.1% ophthalmic solution], and CEQUA™ [cyclosporine 0.09% ophthalmic solution]), XIIDRA® (lifitegrast), a leukocyte function-associated antigen-1 (LFA-1)/intracellular adhesion molecule-1(ICAM-1) inhibitor, EYSUVIS™ (loteprednol etabonate ophthalmic suspension 0.25%), a corticosteroid, and MIEBO™ (perfluorohexyloctane ophthalmic solution), a semifluorinated alkane. TYRVAYA™ (varenicline solution nasal spray), a cholinergic agonist, is another formulation approved for the treatment of the signs and symptoms of DED...Cyclosporine formulations TJO-087 (cyclosporine A nanoemulsion 0.08%), SCAI-001 eye drops (cyclosporine 0.01%, 0.02%) are being evaluated against RESTASIS® and other approved treatments. The potential treatments being assessed include..."

Journal • Review • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome • ICAM1

Improving Drop Instillation Comfort of a Cyclosporine A Solution (clinicaltrials.gov) - P=N/A | N=40 | Completed | Sponsor: University of Waterloo | Recruiting ➔ Completed

Trial completion • Dry Eye Disease • Ophthalmology

The COAT Trial: Cequa's Onset of Action Trial (clinicaltrials.gov) - P4 | N=52 | Completed | Sponsor: Research Insight LLC

New P4 trial • Dry Eye Disease • Ophthalmology

CycliP: Cyclosporine and Intense Pulsed Light for Dry Eye in Contact Lens Users (clinicaltrials.gov) - P3 | N=44 | Recruiting | Sponsor: Université de Sherbrooke

New P3 trial • Dry Eye Disease • Ophthalmology

CEQUA for Sjogren's Syndrome Dry Eye (clinicaltrials.gov) - P4 | N=50 | Completed | Sponsor: Center for Ophthalmic and Vision Research, LLC | Recruiting ➔ Completed

Trial completion • Dry Eye Disease • Immunology • Ophthalmology • Sjogren's Syndrome

Early Adoption and Utilization of Perfluorohexyloctane for Treatment of Dry Eye Disease (ISPOR 2024) - " Adults (≥18 years) in the Veradigm Network Electronic Health Record (VNEHR) Database initiating DED treatment with either perfluorohexyloctane, cyclosporine ophthalmic solution 0.05% (CYC-S) (Restasis), lifitegrast (LFT) (Xiidra), and cyclosporine ophthalmic emulsion 0.09% (CYC-E) (Cequa) from September 2023 to December 2023 were selected... Early adopters of PHO were slightly younger and had a higher proportion of patients with a DED diagnosis compared to other agents. PHO tended to have more treatment-experienced patients in the 12 months prior to initiation, potentially highlighting a subgroup of the patient population who were waiting for a new treatment option for evaporative DED in addition to inflammation."

Cataract • Dry Eye Disease • Glaucoma • Inflammation • Ocular Inflammation • Ophthalmology

Perfluorohexyloctane ophthalmic solution (Miebo) for dry eye disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dry Eye Disease • Ophthalmology

Tear Film Markers in Dry Eye Syndrome (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: Vishal Jhanji | N=50 ➔ 0 | Trial completion date: Jan 2025 ➔ Dec 2023 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Dec 2024 ➔ Dec 2023

Enrollment change • Immunomodulating • Trial completion date • Trial primary completion date • Trial withdrawal • Dry Eye Disease • Ophthalmology • IL6 • MMP9

Improving Drop Instillation Comfort of a Cyclosporine A Solution (clinicaltrials.gov) - P=N/A | N=40 | Recruiting | Sponsor: University of Waterloo | Trial completion date: Aug 2023 ➔ Apr 2024 | Trial primary completion date: Aug 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • Dry Eye Disease • Ophthalmology

Real-world treatment patterns of OTX-101 ophthalmic solution, cyclosporine ophthalmic emulsion, and lifitegrast ophthalmic solution in patients with dry eye disease: a retrospective analysis. (PubMed, BMC Ophthalmol) - "Patients receiving OTX-101 remained on treatment significantly longer and were significantly less likely to discontinue treatment than patients on CsA. Older patients remained on OTX-101 significantly longer than CsA. These findings highlight treatment pattern differences in patients with DED receiving these anti-inflammatory agents."

HEOR • Journal • Real-world • Real-world evidence • Retrospective data • Conjunctivitis • Dry Eye Disease • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome

Role of Polymeric Micelles in Ocular Drug Delivery: An Overview of Decades of Research. (PubMed, Mol Pharm) - "In this context, we are discussing the anatomy of the eye, various ocular barriers, different micellar formulations, and their benefits in ocular drug delivery, as well as the role of PMs in the management of ocular diseases both in preclinical models and in clinic. The encouraging preclinical effectiveness findings from experiments conducted in both laboratory settings and live animals have paved the way for the advancement of micellar systems in clinical trials for ocular administration and the first nanomicallar formulation approved for clinical use by the United States Food and Drug Administration (marketed as Cequa by Sun Pharmaceuticals)."

Journal • Review • Ophthalmology