Eyedrops. Nasal sprays. Punctal plugs. In the world of eye care, the number of treatments aimed at patients who suffer from the discomfort and frustration of dry eye disease (DED) is growing.
Add Lacrifill Canalicular Gel, an innovative hyaluronic acid treatment that targets the lacrimal system, to the armamentarium.
Nordic Pharma, Inc, a part of Nordic Group B.V., introduced Lacrifill in June. Formulated from a cross-linked hyaluronic acid derivative, the interventional viscoelastic treatment works by blocking tear drainage in the canalicular system.
Lacrifill was originally developed by Visant Medical, which Nordic Pharma acquired in December 2023. A prospective, multicenter, controlled, double-masked, randomized non-inferiority clinical trial that pitted Lacrifill against its closest analogue, Oasis Form Fit Intracanalicular punctal plugs (Oasis Medical), found significant improvements from baseline in anesthetized Schirmer, corneal staining and symptoms (OSDI) at 3 and 6 months. The most common device- related adverse events were mild pain on insertion and epiphora.
An ‘and’ Product, Not an ‘or’ Product
The goal in developing Lacrifill was to address a continuing need for safe, effective and innovative treatments for DED, says Philip Gioia, president of Nordic Pharma. Lacrifill is intended to complement, not replace, existing treatments such as artificial tears, he adds. “We see it as an ‘and’ product, not an ‘or’ product — as an expansion of the [DED treatment] category.”
Indeed, among the many prescription DED treatments approved for marketing in recent years are Miebo (perfluorohexyloctane ophthalmic solution; Bausch + Lomb, Novaliq), which was approved in May 2023, followed one month later by Vevye (cyclosporine 0.1%, Harrow). Those medications joined Cequa (cyclosporine ophthalmic solution 0.09%, Sun Ophthalmics), Xiidra (lifitegrast ophthalmic solution, Bausch + Lomb); Eysuvis (loteprednol etabonate, Alcon); and Restasis (cyclosporine ophthalmic emulsion, AbbVie).
“Some great products have been launched in the past year, and we are not competing with those products,” says Jai Parekh, MD, MBA, chief commercial officer of Nordic Pharma Eye Care. According to the National Eye Institute, about 16 million Americans have DED.
Versatility for Many Patients
Lacrifill works on the principle of lacrimal occlusion. The treatment doesn’t have to be customized to fit each patient’s puncta. Instead, it is administered to the lacrimal system to ensure complete filling of the canilicular system.
Lacrifill, which can be used in a wide range of cataract, glaucoma and refractive surgery patients experiencing dry eye symptoms, comes in a prefilled syringe sufficient for administration in both eyes of one patient.
“Because of the way that [Lacrifill fits], you’re going to be able to utilize it on every patient and not worry about sizing each patient’s puncta and keeping a large inventory of punctal plugs sitting on your shelves,” says Selina McGee, OD, FAAO, founder of Bespoke Vision in Edmond, Okla.
Inder Paul Singh, MD, president of The Eye Centers of Racine & Kenosha, Wis., agrees, adding that punctal plugs can sometimes produce a foreign-body sensation because they sit “a little elevated” above the punctal opening.
“We had ‘smart plugs’ many years ago that went in and expanded, but that caused some inflammation locally,” he says. “A viscoelastic material that conforms to any punctum lacrimal system size and shape lends itself to more customization to the patient, more flexibility for the surgeon, and less symptoms of discomfort during and after the procedure,” he says.
Dr. Singh adds that, unlike punctal plugs, there is also no risk of Lacrifill “falling out.”
Procedure Insights
Lacrifill also offers benefits to ophthalmologists and optometrists. For one, the learning curve is short, according to Dr. Singh. The gel is inserted through 27-g cannula into the opening of the punctum. The viscoelastic then makes its way through the lacrimal system to help keep tears on the ocular surface.
The in-office procedure requires no special training, as it is virtually identical to irrigating the tear duct. It also takes just a few minutes, remains effective for 6 months, and can be repeated as necessary, according to the company.
Dr. McGee, who performs the procedure behind a slit lamp, notes that it can also be performed using loupes. “You can do it either way. You just put a cannula on your syringe. I like the cannula that I used because it doesn’t make it hard to push and it doesn’t come off. It’s so easy. I was actually surprised how easy it is,” she says.
Another benefit to physicians is that, owing to its FDA clearance, Lacrifill Gel is fully reimbursable through CPT code 68761.
“I did my first one and I was paid within 10 days [by the patient’s] insurance company. That’s lovely because our typical interventional dry eye methodologies are not reimbursed by insurance,” says Dr. McGee.
Early Reviews Are In
Although Lacrifill only became available in June and Drs. Singh and McGee have used it on fewer than a dozen patients, they say that early indications are promising.
“The patient response has been very positive, no discomfort,” Dr. Singh says. “It’s a pretty straightforward procedure. There’s not a lot of set up time, no post-op or post-procedure restrictions. So, I think it’s a pretty easy in-and-out procedure from the patient perspective.” OM
Disclosures: Dr. McGee is a member of the medical advisory board of Nordic Pharma.
Dr. Singh is a consultant for Nordic Pharma.
