cyclosporine ophthalmic emulsion / Generic mfg. - LARVOL DELTA

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

Could Bilateral Progressive Corneal Ectasia Be Transient? Exploring A Case Of Full Reversibility (ESCRS 2024) - "Preservative- free tear substitute and 0.1% cyclosporine ophthalmic emulsion quid were prescribed...Proper recognition of the VKC complications is crucial, as most of these can be managed or prevented. Despite the accuracy of diagnostic tools in diagnosing KC, they cannot replace an accurate clinical examination."

Clinical • Achromatopsia • Astigmatism • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology

Improvement In Total Corneal Staining And Visual Acuity With Cyclosporine Ophthalmic Solution 0.09% In A Phase 4 Study Of Patients With Dry Eye Disease Inadequately Controlled By Cyclosporine Ophthalmic Emulsion 0.05% (ESCRS 2024) - "Twice-daily CsA 0.09% was associated with significant improvements in both total CFS score and BCVA OU at Week 12 of treatment. Additionally, significant reductions in total CFS score in both the right and left eyes were noted at Week 12 regardless of relative BCVA. CsA 0.09% was generally well tolerated throughout the study."

Clinical • P4 data • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Improved Signs and Symptoms of Dry Eye Disease for Restasis® Patients Following a Single Tearcare® Treatment: Phase 2 of the SAHARA Study. (PubMed, Clin Ophthalmol) - "SAHARA showed 6-month superiority of LHT to CsA in clinical signs and non-inferiority in symptom scores. This extension shows that patients treated with CsA for 6 months can achieve meaningful additional improvement in signs and symptoms lasting for as long as 6 months following a single LHT treatment without the need for topical prescription therapy."

Clinical • P2 data • Dry Eye Disease • Ophthalmology

HU007 in Patients With Dry Eye Syndrome (clinicaltrials.gov) - P3 | N=328 | Completed | Sponsor: Huons Co., Ltd. | Recruiting ➔ Completed

Head-to-Head • Trial completion • Dry Eye Disease • Ophthalmology

P2X4 receptor antagonist ameliorate neuropathic ocular pain in a rat lacrimal glands removal model (ARVO 2024) - "Two weeks after the surgery (post-surgery), we divided the animals into three groups: vehicle, 0.05% cyclosporine ophthalmic emulsion, and Bay293 in vehicle at 2.5mg/ml... P2X4 antagonist Bay293 decreased the discomfort perception and enhanced eye comfort, offering a valuable alternative to chronic ocular discomfort management alongside cyclosporine."

Preclinical • Dry Eye Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • Optic Neuritis • P2RX4

Effect of Topical Administration of Novel anti-Interferon-Gamma Aptamer in severe Murine Dry Eye model (ARVO 2024) - "TXB-0063, anti-IFN-γ DNA aptamer elucidated a prominent efficacy in the dry eye model by both therapeutic and preventive administration. The efficacy of TXB-0063 observed in the severe DED model was observed in an early on-set than that of Restasis® and Xiidra®, and it also improved CD4+ T cell infiltration to the same level to the normal and goblet cell count to the normal levels. These findings suggest that this innovative TXB-0063, anti-IFN-γ aptamer has a potential to be developed to treat severe DED including Sjögren's syndrome related dry eye."

Preclinical • Corneal Abrasion • Dry Eye Disease • Ophthalmology • CD4 • IFNG

Cyclosporine Ophthalmic Solution 0.09% Improves the Signs and Symptoms of Dry Eye Disease in Patients Whose Disease Is Inadequately Controlled on Cyclosporine Ophthalmic Emulsion 0.05% (ISPOR 2024) - "Twice-daily CsA 0.09% was the preferred treatment by most patients and resulted in significant improvements in the signs and symptoms of DED at Week 12 in patients whose disease was inadequately controlled on CsA 0.05%."

Clinical • Dry Eye Disease • Inflammation • Ocular Inflammation • Ophthalmology

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

Efficacy of cyclosporine ophthalmic solution 0.09% in patients with dry eye disease uncontrolled on cyclosporine ophthalmic emulsion 0.05% (AMCP 2024) - No abstract available

Clinical • Dry Eye Disease • Ophthalmology