cyclosporine ophthalmic emulsion / Generic mfg. - LARVOL DELTA

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

Optimization and formulation of cyclosporine-loaded nanostructured lipid carriers (NLCs) for the management of dry eye syndrome by using centre composite design approaches. (PubMed, Int Ophthalmol) - "Among the therapeutic agents used, Cyclosporine A (CsA) plays a critical role in modulating immune-mediated inflammation associated with DES. Conventional CsA formulations, like oil-in-water emulsions (e.g., Restasis®), fail to perform as well in the healthcare setting because they fail to disintegrate well in water, fail to distribute to the eye well, take a long time to work, and can irritate patients...At 12 h, the cumulative drug permeation from the CsA-NLCs reached 47.5 ± 1.5 µg/cm2, and the formulation is stable. The findings indicate that NLC-based CsA formulations represent a viable alternative for the effective and patient-compliant management of DES."

Journal • Dry Eye Disease • Inflammation • Ocular Inflammation • Ophthalmology • Pain

Physicochemical Fingerprinting of Cyclosporine A Ophthalmic Emulsions as a New Approach Methodology for Clinical Tolerability. (PubMed, J Ocul Pharmacol Ther) - "Restasis exhibited substantially higher viscosity than Ikervis across all shear rates, whereas Ikervis and the CMC reference showed comparable high-shear viscosity despite markedly different reported tolerability-a viscosity-discomfort dissociation. The proposed framework is hypothesis-generating rather than mechanistically conclusive; it is intended to support future targeted validation studies rather than replace clinical evaluation. GC-MS may serve as a useful complementary fingerprinting tool within NAM/IATA-aligned ophthalmic formulation assessment."

Journal • Ophthalmology • Pain

REAL-WORLD UTILIZATION AND TREATMENT ADHERENCE OF BRAND AND GENERIC CYCLOSPORINE OPHTHALMIC EMULSION IN DRY EYE DISEASE (ISPOR 2026) - "Adherence to cyclosporine therapy for DED was very low. Generic users were more likely to switch and discontinue than brand users, and this may be due to complex ophthalmic formulations. More work is needed to understand the role of clinical tolerability, effectiveness, and costs in treatment adherence in DED."

Adherence • Clinical • Real-world • Real-world evidence • Dry Eye Disease • Ophthalmology

Artificial tears and immunosuppressive therapy for immune-mediated disorders of the ocular surface (PubMed, Vestn Oftalmol) - "In the acute stage or during exacerbations of severe immune-mediated lesions, the drug of choice is the glucocorticosteroid (GCS) dexamethasone...Although the use of cyclosporine A, including in the form of a cationic emulsion (Ikervis), is considered ineffective for most forms of dry eye disease, it may be used in a selected group of patients with moderate immune keratoconjunctivitis...As for mandatory tear substitution therapy in this patient population, combined formulations containing hyaluronic acid and the reparative agent dexpanthenol appear promising. The composition of Stillavit Intensive provides reliable hydration of ocular surface tissues due to sodium hyaluronate 1.8 mg, additional anti-inflammatory effects mediated by sodium chondroitin sulfate, and regeneration of the conjunctival and corneal epithelium through D-panthenol 50.0 mg."

Journal • Review • Conjunctivitis • Dry Eye Disease • Immunology • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

A Study to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants With Moderate to Severe Vernal Keratoconjunctivitis (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Laboratoires Thea | Not yet recruiting ➔ Recruiting

Enrollment open • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology

Comparison of two different topical 0.05% cyclosporine A formulations on ocular surface outcomes following pterygium excision with conjunctival autograft. (PubMed, Medicine (Baltimore)) - "Postoperatively, patients were administered either 0.05% CsA emulsion (CsA-E; Restasis®, Allergan Inc., Irvine) or 0.05% CsA nanoemulsion (CsA-NE; Cyporin N®, Taejoon Pharm Co., Ltd., Seoul, Republic of Korea) twice daily for 12 months...Both CsA formulations were effective in preventing pterygium recurrence with comparable safety profiles. Additionally, both groups achieved excellent and comparable postoperative VA."

Clinical • Journal • Retrospective data • Ophthalmology

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

LT1695-201: A Study to Compare the Effectiveness and Safety of T1695 (0.1% Tacrolimus) Versus Ciclosporin in Participants With Moderate to Severe Vernal Keratoconjunctivitis (clinicaltrialsregister.eu) - P1/2 | N=72 | Not yet recruiting | Sponsor: Laboratoires Thea

New P1/2 trial • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology

Amneal Announces U.S. FDA Approval of Cyclosporine Ophthalmic Emulsion 0.05% (GlobeNewswire) - "The product is the generic equivalent of RESTASIS (cyclosporine ophthalmic emulsion) 0.05%, a registered trademark of Allergan, an AbbVie company....Cyclosporine ophthalmic emulsion 0.05% is a topical immunomodulator indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with dry eye syndrome....Launch expected in Q1 2026."

ANDA • Generic launch • Dry Eye Disease

Switching From Restasis to TRYPTYR (clinicaltrials.gov) - P4 | N=100 | Not yet recruiting | Sponsor: Southern College of Optometry

New P4 trial • Dry Eye Disease • Ophthalmology

Safety And Effectiveness Of The TearCare® System In The Treatment Of The Signs And Symptoms Of Dry Eye Disease (SAHARA) (clinicaltrials.gov) - P=N/A | N=345 | Completed | Sponsor: Sight Sciences, Inc. | Active, not recruiting ➔ Completed

Trial completion • Dry Eye Disease • Ophthalmology

Ion-activated gellan gum in situ gel for prolonged ocular administration of tofacitinib citrate: An innovative treatment approach for dry eye disease. (PubMed, Int J Pharm) - "In the benzalkonium chloride-induced DED rat model, TFC-ISG demonstrated superior efficacy over commercially available cyclosporine ophthalmic emulsion (0.05 %) and sodium hyaluronate eye drops (0.3 %). This synergistic dual action - concurrently restoring ocular surface function and suppressing inflammation - effectively mitigated DED progression. Thus, TFC-ISG emerges as a highly promising novel formulation for DED treatment, thereby offering a valuable new therapeutic option."

Journal • Dry Eye Disease • Inflammation • Ocular Inflammation • Ophthalmology • IL18 • IL1B • IL6 • MMP2 • MMP9 • TNFA

A Study to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants With Moderate to Severe Vernal Keratoconjunctivitis (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Laboratoires Thea

New P2 trial • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology

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

Journal • Dry Eye Disease • Ophthalmology

A Retrospective Crossover Study on Cross-Linked Hyaluronic Acid Gel (Lacrifill) Versus Cyclosporine A 0.05% (Restasis) for Dry Eye Disease. (PubMed, Cureus) - "Lacrifill provided superior tear retention and symptom relief during the first two months of treatment compared to Restasis in refractory aqueous-deficient DED, supporting occlusion therapies in DED management. Larger prospective trials are needed to confirm efficacy and explore the use of combination therapies (typically three to six months)."

Journal • Retrospective data • Dry Eye Disease • Ophthalmology

Assessment the Safety of CyclASol compared with Vehicle and Commercially Available 0.05% Cyclosporine in Dry Eye Disease: A Systematic Review and Meta-analysis. (PubMed, Ophthalmol Ther) - "Based on the data presented in the meta-analysis, CyclASol is a safe treatment for patients with DED. However, the comparable likelihood of experiencing TEAEs and ocular TEAEs between CyclASol and 0.05% CsA suggests that there is not sufficient evidence to indicate a superior safety profile of CyclASol over commercially available CsA."

Journal • Retrospective data • Dry Eye Disease • Ophthalmology

Early Adoption and Utilization of Perfluorohexyloctane for Dry Eye Disease in the United States. (PubMed, Clin Ophthalmol) - "To characterize early adopters of perfluorohexyloctane (PFHO) and 90-day refill rates after the first prescription, overall and compared to a cohort initiating cyclosporine ophthalmic emulsion 0.05% (CsA)...High DED medication use among PFHO patients in the 12-month period prior to treatment initiation suggests that prior medication may not have resolved their DED symptoms. The higher 90-day refill rate for PFHO versus CsA indicates a higher degree of patient satisfaction with this new, first-in-class treatment for DED."

Journal • Dry Eye Disease • Ophthalmology

TearCare system versus cyclosporine ophthalmic emulsion for the treatment of moderate-to-severe meibomian gland disease associated dry eye disease in the United States: a cost-utility analysis. (PubMed, Expert Rev Pharmacoecon Outcomes Res) - "The incremental cost-effectiveness ratio (ICER) showed TearCare to be dominant (more effective and less costly). TearCare is a cost-effective treatment for MGD-related DED, offering both clinical benefits and cost savings over CsA."

HEOR • 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

Topical Cenegermin-Bkbj Dramatically Resolves Neurotrophic Keratitis Associated With Pars Plana Vitrectomy. (PubMed, Ophthalmic Surg Lasers Imaging Retina) - "A 60-year-old woman with recurrent retinal detachments in the right eye after receiving the third PPV developed persistent irritation, photophobia, and worsening visual acuity due to iatrogenic NK despite lubrication, bandage contact lens, preservative-free artificial tears, restasis, and right lower lid punctal cautery over 6 weeks. This case highlights the importance of early recognition, tailored management, and the potential efficacy of Cenegermin-Bkbj in treating NK arising after retinal procedures. [Ophthalmic Surg Lasers Imaging Retina 2025;56:XX-XX.]."

Journal • Keratitis • Ocular Inflammation • Ophthalmology • Retinal Disorders

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

Journal • Dry Eye Disease • Ophthalmology

Hyaluronic acid conjugates with controlled oleic acid substitution as new nanomaterials for improving ocular co-delivery of cyclosporine A and oleic acid. (PubMed, Asian J Pharm Sci) - "CsA-loaded HONs exhibited improved solution transparency via solubilizing capacity of HON, and increased in vitro drug permeation compared to Restasis®. Interestingly, this CsA-loaded HON1 as optimal ocular nanoformulation showed markedly augmented macrophage polarization into the M2 phenotype, downregulated the expression of proinflammatory cytokines levels in LPS-induced M1 macrophage, and effectively inhibited VEGF-induced endothelial cell proliferation and capillary-like tube formation by the synergistic effect of CsA and HON1 containing OA at the same time. Collectively, the current fatty acid conjugated to HA, named fattigation platform, providing the roles and physicochemical properties via structural features of HA could be a promising co-delivery strategy of drug and fatty acid for DED and other ophthalmic disease treatments."

Journal • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Efficacy and Safety of Topical Cyclosporine 0.05% and Lifitgrast on the Ocular Surface Symptom After Photorefractive Keratectomy in Feiz Hospital, Isfahan, 2024 (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: Mohsen Pourazizi

New P1 trial • Inflammation • Ocular Inflammation • Pain

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