Harrow has received a permanent J-Code from the Centers for Medicare & Medicaid Services (CMS) for IOPIDINE 1% (apraclonidine hydrochloride ophthalmic solution), enabling its in-office use.
Hold up — IOPIDINE isn’t exactly a new drug, right?
Not at all. In fact, the FDA first approved the ophthalmic solution in 1987.
However, Harrow’s involvement with IOPIDINE didn’t begin until 2021, in which the company acquired the U.S. commercialization rights to several branded ophthalmic drugs from Novartis.
- Among these: IOPIDINE 1% (and 0.5%).
Following the deal’s closing, the manufacturing and distribution responsibilities of these products gradually shifted over to Harrow (including their respective new drug applications [NDAs]).
By June 2022, all NDA transfers were complete, and the company announced the U.S. commercial availability of IOPIDINE 1% under the Harrow name.
Alrighty, now let’s get a look at this solution.
Its indication: For the control or prevention of post-surgical elevations in intraocular pressure (IOP) that occur in patients following ophthalmic procedures (including in-office-based) such as:
- Yttrium aluminum Garnet (YAG)
- Nd capsulotomy
- Selective laser trabeculoplasty (SLT)
- Argon laser trabeculoplasty (ALT)
- Laser peripheral iridotomy (LPI)
To note: IOPIDINE is the only FDA-approved product for this indication.
And the recommended dosing?
Per its prescribing information (PI): One drop should be instilled in the operative eye 1 hour before anterior segment laser surgery.
- A second drop is to be instilled immediately following the procedure
Notably: A new single-use container should be used for each drop (and discarded after use).
And how soon are its effects felt?
The onset of action is typically noted within 1 hour, and the maximum IOP reduction generally occurs at 3 to 5 hours post-application of a single dose, according to the PI.
Now, before we get into its safety, talk about this J-Code.
What it is: A permanent reimbursement under the Healthcare Common Procedure Coding System (HCPCS), which standardizes claims for medical services and supplies into two main subsystems (Levels I and II).
To note: In the instance of IOPIDINE, the solution would fall under HCPCS’s Level II system due to its in-office, clinician-administered application.
Keep in mind: HCPCS is also used by government payors and commercial insurers to simplify and facilitate the billing and reimbursement process for medical providers’ products and services.
How many HCPCS codes are there?
Three in total. But in the instance of J-codes (J0120 - J8999), these refer to drugs administered via routes that exclude oral methods.
In essence: This CMS billing designation allows physicians to be reimbursed directly for in-office-administered drugs.
- See here for details on the other two codes.
And what’s IOPIDINE’s new code?
Per CMS: J2374.
Is there a big-picture significance to this?
Indeed. As Harrow pointed out, the J-code assignment “removes a longstanding practical barrier to routine use of IOPIDINE 1% for office-based procedures,” making it easier for physicians to incorporate into standard glaucoma and ophthalmic laser procedure workflows.
So when will this take effect?
July 1.
Alrighty, now let’s talk safety: contraindications, warnings, or precautions.
The drop is contraindicated for patients:
- Receiving monoamine oxidase inhibitor patients
- With hypersensitivity to any component of the medication (or to clonidine)
As for warnings/ precautions:
- Due to its classification as a potent depressor of IOP, patients with exaggerated IOP reductions should be closely monitored
- Click here for more.
Along the lines of caution, any associated adverse reactions?
IOPIDINE’s PI noted a few adverse events (AEs) that occurred following laser surgery among less than 2% of patients during clinical evaluations:
- Ocular injection, upper lid elevation, irregular heart rate, nasal decongestion, ocular inflammation, conjunctival blanching, and mydriasis.
See here (scroll to pages 4 and 5) for more, including those based on post-marketing use.