New technology improves drug’s stability

Cequa increases tear production in dry eye disease (DED) patients. It’s delivered via nanomicellar (NCELL) technology, which helps to improve the bioavailability and physicochemical stability of cyclosporine.

Overview

“NCELL technology works by blending two unique polymers that self-assemble into nanomicelles that encapsulate cyclosporine molecules within its hydrophobic core, while the hydrophilic outer layer is soluble in the aqueous tear film,” explains Mark Hagler, senior vice president and head of Ophthalmics, Oncology, and Long Term Care, Sun Pharmaceutical Industries Inc., in Princeton, N.J. “This delivery technology helps to solubilize cyclosporine and improves its bioavailability to the ocular surface for easier penetration.”

Cequa’s delivery system enables it to penetrate more quickly, allowing for a greater concentration to pass through the cornea, says Audrey Talley Rostov, MD, director of Cornea, Cataract, and Refractive Surgery, and a partner at Northwest Eye Surgeons, in Seattle WA.

“If patients are already using artificial tears without success, then they need to go to the next level,” she explains. “That includes using topical cyclosporine, which has been used for decades to treat DED. Cequa is the newest innovation in topical cyclosporine.”

Benefits Abound

Cequa is made for the long-term treatment of DED. It addresses the inflammatory component of the disease by helping patients produce more tears that last longer and tears that are healthier, Dr. Talley Rostov says. Cequa also helps patients produce more tears over time and improves the health of the ocular surface.

Mr. Hagler adds that Cequa improves central and total corneal staining as early as one month of treatment.

Dr. Talley Rostov says Cequa can also benefit patients who plan to have refractive surgery. If a cornea surface is very dry, for example, a physician could make an incorrect calculation for a lens implant. She also recommends using Cequa after surgery because if DED is significant, patients will need it long term.

The drug can also be used with a steroid to help treat DED. “I might start a patient with a topical steroid plus Cequa for immediate relief, and then take the patient off the steroid and maintain them on Cequa,” she says. “Cyclosporine is well tolerated; patients can use it for a long time without having an increase in eye pressure.”

Study Results

Cequa clinical study data attest to its benefits. In a multi-centered, randomized, double-masked, vehicle-controlled Phase 3 study involving 744 DED patients, researchers observed clinically and statistically significant improvements in tear production and ocular surface integrity in patients treated with Cequa, compared to vehicle. The treatment was well tolerated; treatment-emergent adverse events were primarily mild in intensity.¹

In a prior 12-week multicenter, randomized, prospective, double-masked, vehicle-controlled, dose-ranging Phase 2b/3 clinical trial with 455 patients, Cequa demonstrated greater improvement in conjunctival staining versus the vehicle-treated patients (P<0.01 for both concentrations). Additionally, most adverse events associated with treatment were mild, with no reports of serious ocular adverse events.²

From both clinical trials, the most common adverse reaction following Cequa use was instillation site pain and conjunctival hyperemia. Other adverse reactions reported in 1% to 5% of patients were eye irritation, blepharitis, urinary tract infection, headache, and bronchitis. For additional information, visit https://cequapro.com/efficacy .

Cequa Support

“Cequa Support” enables commercially insured patients to obtain it. When a patient’s prescription is submitted, the program provides insurance plan benefit verification, prior authorization support, and appeals assistance, Hagler says. CP

References

1. Goldberg DF, Malhotra RP, Schechter BA, Justice A, Weiss SL, Sheppard JD. A phase 3, randomized, double-masked study of OTX-101 ophthalmic solution 0.09% in the treatment of dry eye disease. Ophthalmology. 2019;126(9):1230-1237.
2. Tauber J, Schechter BA, Bacharach J, et al. A phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease. Clin Ophthal. 2018;12:1921-1929.