Using a unique vehicle, Cequa delivers more medicine to conquer dry eye.

As an ophthalmologist who likely treats many dry eye patients, you now have a new weapon to target this stinging, burning enemy of vision — Sun Pharma’s Cequa, only the third prescription product for this population in almost 20 years.

Cequa (cyclosporine ophthalmic solution 0.09%) received FDA marketing approval in August 2018 to increase tear production in dry eye patients. The drug was launched in October 2019, fueled by a host of clinical trials confirming its efficacy in treating a condition that affects as many as 16 million people in the United States, according to a 2019 study published in Clinical Ophthalmology by Bradley et al.¹

Besides delivering the highest concentration of cyclosporine available (0.09%), Cequa features NCELL, the branded name for its unique “nanomicellar” formulation, which the company says helps the drug overcome solubility challenges, penetrate the eye’s aqueous layer and prevent release of the drug before reaching the aqueous layer.

Micelles consist of hydrophobic and hydrophilic amphipathic molecules, and the extra small size of nanomicelles enables them to deliver the high concentrations of CsA to the corneal and conjunctival cells, according to the company.

Dosed twice daily from single-use vials, Cequa is an important addition to the existing dry eye armamentarium of Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan) and Xiidra (liftegrast ophthalmic solution, Novartis), says Laura Periman, MD, an ophthalmologist and dry eye specialist at The Dry Eye Clinic in Seattle, Wash.

“We need more weapons [to treat dry eye], and what is so exciting is that Cequa’s another arrow in the quiver,” she says.

HEALING THE CORNEA

While Cequa is indicated for dry eye only, most of the condition’s U.S. sufferers also have vision comorbidities such as cataracts, glaucoma and/or meibomian gland disorder (MGD), making for a potentially significant pool of patients that can also benefit from Cequa’s ability to prepare their eyes for optimal treatment, Dr. Periman says.

In the Phase 3 trials, statistically significant improvements were seen in Schirmer’s scores, the primary endpoint. After 12 weeks, 16.6% of patients showed an increase of ≥10 mm in Schirmer’s score from baseline, compared to 9.2% for vehicle; p<0.01. Significant corneal staining improvements were also observed as early as 1 month after initiation of treatment.

“[Corneal staining] becomes something to pay close attention to, particularly when we are getting our patients ready for cataract surgery,” explains Dr. Periman. While the Schirmer’s score results were good — about equal to those of Restasis, she says, “What’s exciting is the corneal staining data. For the patient with significant pain in his or her cornea, that’s damage to the cornea, and the patient’s preop IOL calculation measurements will be wonky.”

With Cequa, “It’s theoretically possible [to] get them rehabbed and ready for cataract surgery in 4 to 6 weeks. It’s not enough just to improve tear production. Now, I’m healing the cornea,” potentially generating a better outcome, Dr. Periman observes.

Marguerite McDonald, MD, FACS, clinical professor of ophthalmology, at NYU Langone Medical Center in New York, N.Y., and at the Tulane University Health Sciences Center, New Orleans, La., agrees.

“If a patient has dry eye and wants LASIK, cataract surgery or pterygium surgery — any kind of surgery where you’re trying to get the patient in tip-top shape very quickly,” Dr. McDonald says, “this is a very reasonable choice because it works so rapidly and the acceptance rate is so high.”

HIGH PATIENT ACCEPTANCE

In Phase 3 clinical trials, Cequa enjoyed a very high acceptance rate among the nearly 750 study subjects. The only major side effect was site pain on instillation, ranked as mild by 20.7% of subjects, moderate by 3%,and severe by only 0.5%.

Just under 5% of subjects quit the trials because of site pain or other reported side effects, which included minor eye irritation, eye pruritus and foreign body sensation, all of which occurred in fewer than 1% of subjects, according to the study.

“When I start my patients on Cequa, I just say, ‘Look, if you find that the instillation pain is bothering you, put it in the refrigerator.’ When drops are cold, they always feel much better,” says Dr. McDonald. She advises those with continued discomfort to instill a preservative-free tear from the fridge, “and then add the chilled Cequa.”

The physicians interviewed note that, in the time since Cequa entered the market, none of their small number of patients treated with Cequa have called with complaints or asked for different medication, “which is extraordinary” for any medication, Dr. McDonald says.

PREVENTIVE MAINTENANCE, NOT DAMAGE CONTROL

Both ophthalmologists agree that Cequa’s value lies not just in addressing dry eye itself, but also in its ability to prevent patient complications with further treatment.

“I really want our colleagues to think preoperatively and not about damage control,” Dr. Periman says. “I want them to think optimization and preventive maintenance, rather than just reacting after the cows have escaped the barn.” OM