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

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

Exploring the Therapeutic Potential of Cyclosporine for Ophthalmic Indications by Novel Carrier Systems. (PubMed, Crit Rev Ther Drug Carrier Syst) - "However, Restasis®, Cequa®, and Verkazia® are the marketed formulations that have been approved by U.S. Food and Drug Administration, whereas Cyclokat® and Ikervis® by the European Medicines Agency. Although these medications are in use, they are associated with severe discomfort and poor patient compliance. This review gives an overview regarding current formulations available in the market, the products in pipeline and the recent advances undertaken for improving ocular delivery of CsA for various ophthalmic indications."

Journal • Ophthalmology

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

New trial • Dry Eye Disease • Ophthalmology

A Retrospective Analysis of Real-World Treatment Patterns in Patients over Age 64 with Dry Eye Disease Receiving OTX-101 Ophthalmic Solution 0.09%, Cyclosporine Ophthalmic Emulsion 0.05%, or Lifitegrast Ophthalmic Solution 5% (ISPOR 2023) - "OTX-101 and CsA patients >64 years were significantly more likely to discontinue treatment than those ≤64 years. Patients >64 years receiving OTX-101 remained on treatment significantly longer than those on CsA; time on treatment was similar for OTX-101 and LFT."

HEOR • Real-world • Real-world evidence • Retrospective data • Dry Eye Disease • Inflammation • Ocular Inflammation • Ophthalmology

"Honored to be part of the official Cequa launch in India!" (@DrToyos)

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

Immunomodulating • Trial primary completion date • Dry Eye Disease • Immune Modulation • Ophthalmology • CXCL8 • IL1R1 • IL6 • MMP9

CEQUA for Sjogren's Syndrome Dry Eye (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: Center for Ophthalmic and Vision Research, LLC | Trial completion date: Jun 2023 ➔ Mar 2024 | Trial primary completion date: Jun 2023 ➔ Mar 2024

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

Aurinia Announces LUPKYNIS (voclosporin) Patent Challenge Settlement Reached With Sun Pharmaceuticals (Aurinia Pharmaceuticals Press Release) - "Aurinia Pharmaceuticals...announces it has entered into a settlement agreement with Sun Pharmaceutical Industries...that involves both Aurinia and Sun Pharmaceuticals filing a joint motion to terminate the ongoing Inter Partes Review (IPR) directed at Aurinia’s U.S. Patent No. 10,286,036, as well as settlement of the ongoing patent infringement litigation in the United States (U.S.) related to Sun’s CEQUA® product. Under the settlement agreement, which is contingent upon the U.S. Patent Trial and Appeal Board approving the joint motion to terminate the IPR..."

Patent • Lupus • Lupus Nephritis • Ophthalmology

Effect of OTX-101 in Patients with Dry Eye Disease at Day 14 of Treatment: Ocular Surface Endpoint Results from the Phase 2b/3 Clinical Trial. (PubMed, Clin Ophthalmol) - "LS mean (SE) change from baseline in modified SANDE total global symptom score was -4.93 (1.54) for OTX-101 and -9.1 (1.54) for vehicle. OTX-101 0.09% demonstrated a numerically greater treatment effect compared with vehicle in conjunctival staining, corneal staining, and TBUT after 14 days."

Journal • P2/3 data • P2b data • Conjunctivitis • Dry Eye Disease • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome

CEQUA for Sjogren's Syndrome Dry Eye (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: Center for Ophthalmic and Vision Research, LLC | Trial completion date: Jun 2022 ➔ Jun 2023 | Trial primary completion date: Jun 2022 ➔ Jun 2023

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