Compounding in ophthalmology
Compounded pharmaceuticals can be another tool at the doctor’s disposal.
By Sharon Richardson, COT, OSA
Compounding is the creation of a pharmaceutical property by a licensed pharmacist. A physician might prescribe a compounded pharmaceutical for a number of reasons. The doctor may want to customize a strength, dose, or formulation of a drop, exclude an unwanted ingredient such as a preservative, or prescribe a drug that is no longer available or is in shortage.
Most compounding is done in a pharmacy that has specific equipment and training to do so safely. These facilities come in two categories: 503A and 503B. Smaller 503A compounding pharmacies are not required to register with the FDA but can only compound with a prescription for a patient. Outsourcing facilities, also known as 503B, can provide bulk amounts of a compounded drug without an individual prescription. These facilities follow the same guidelines pharmaceutical companies follow for the manufacturing of the FDA-approved drugs. While the facilities are regulated by the FDA, compounding pharmacy therapies are not subject to premarket approval requirements. And, although the compounded drugs are not FDA approved, each ingredient in the formulation of a compounded drug is FDA approved.
An ophthalmologist may choose to prescribe a compounded drop for a number of reasons, such as an aversion to a preservative found in a commercially available drop or cost to the patient. The doctor also might prescribe a compounded drop to combine multiple therapies into a single drop — for instance, in the case of a glaucoma patient who has been prescribed multiple IOP-lowering drops. This compounded combination drop can result in fewer preservatives taken in by the patient, increased compliance, and lowered cost to the patient. It’s worth noting that insurance plan coverage can also affect price, as branded drugs may receive insurance coverage where compounded pharmaceuticals do not.
Compounding pharmacies are another tool available to the ophthalmology community to meet the needs of its patients. Knowing what they are, how they work, and how they may be utilized are the first steps in helping to utilize them.
In Brief
Glaukos and Avedro announced a definitive merger agreement, where Avedro will be acquired in an all-stock transaction. The merger, which has been approved by the boards of directors at both companies, is expected to be completed in the fourth quarter of 2019.
OD-OS released a software update for its Navilas 577s retina laser. The update includes a new “multimodal export wizard” that allows ophthalmologists to generate high resolution images of their treatments in different configurations.
The new Oculus Pentacam AXL Wave combines five measurement categories: Scheimpflug tomography, axial length, total eye wavefront, objective refraction, and retroillumination.
Regeneron’s Eylea (aflibercept) Injection prefilled syringe received FDA approval. The 2 mg, single-dose, sterilized prefilled syringe offers the same medicine as the currently available Eylea.
A permanent J-code was assigned to Omeros’ Omidra 1% / 0.3% from the CMS. Omidra is a commercial drug used during cataract surgery to prevent miosis and reduce postoperative pain. The J-code, J1097, will become effective on Oct. 1.
A permanent J-code was assigned to Ocular Therapeutix’s Dextenza 0.4 mg from the CMS. Dextenza is a dexamethasone ophthalmic insert to treat ocular inflammation and pain after ocular surgery. The code, J1096, will become effective on Oct. 1.
A permanent J-code was assigned to EyePoint Pharmaceuticals Yutiq 0.18 mg intravitreal implant, a three-year micro-insert for chronic, non-infectious uveitis of the posterior segment. The code, J7314, will become effective on Oct. 1.
Alcon launched a new educational LASIK website, www.YourLasikSolution.com . The website contains an overview of Alcon’s CONTOURA Vision LASIK technology, as well as input from LASIK patients about what information they needed to make an informed decisions about the LASIK procedure.
Stowe Pharmaceuticals Inc., a Harrow Health Inc. subsidiary, entered into an agreement with TGV Health to acquire worldwide rights to Zian, an anti-microbial molecule for ophthalmic and otic uses. The patented small molecule is water soluble, colorless and odorless, developed to treat various complex bacterial, fungal and viral infections, including in the eye. The company expects to pursue FDA approval via 505(b)(1).
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