Over the last decade, there have been incredible innovations in drug delivery platforms that have improved outcomes and bolstered patient satisfaction. Peri-operatively, they have put more control in the surgeon's hands, leading to more predictable results. Post-operatively, these novel drug delivery platforms have reduced the eye drop burden for patients resulting in greater compliance.
In this article, three leading ophthalmologists share why they have adopted these technologies and how they have improved their protocols and practice.
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Modified steroid molecules
Within the surgical suite, ophthalmologists can control nearly every variable surrounding the procedure to heighten the level of success. However, once a patient leaves the office, many factors can impact those results, such as having to accept a substitution of the prescribed eye drops for a generic version from the pharmacy, not properly shaking the bottle prior to instillation, or simply forgetting their drops.
Steroid eye drops with modified formulations not only offer greater reliability and efficacy but also enhance overall patient compliance. In the realm of eyedrops with modified steroid molecules, Inveltys and Lotemax SM are both game changers.
Inveltys (loteprednol etabonate ophthalmic suspension 1%, Alcon) utilizes mucopenetrating nanoparticles and need only be instilled twice daily. According to a press release from the original manufacturer, post-operative (day 8 through 15), patients had complete resolution of inflammation and pain, compared with placebo.
Approved for the treatment of post-operative ocular inflammation and pain, Lotemax SM (loteprednol etabonate ophthalmic gel 0.38%, Bausch + Lomb) contains the lowest concentration of loteprednol currently available on the market for this particular indication. Dosing is scheduled at three times daily.
Greater reliability and efficacy
When reviewing the ability of a drug to maintain peak performance for a surgical patient, it is highly recommended to pay careful attention to the formulation, specifically a branded product vs. a generic version.
As a glaucoma specialist, Dr. Singh, who has used both Inveltys and Lotemax SM, stressed the importance of a medication's inactive ingredients and having a known dependable drug vehicle. Dr. Radcliffe pointed out that any reformulation of a medication can have an immense impact on allergy rate, tolerability and efficacy. For these reasons, all three surgeons recommend using only branded eye drops post-operatively.
The formulations of both Inveltys and Lotemax SM are not only reliable, but revolutionary per the surgeons. Inveltys is formulated with AMPPLIFY, which enhances penetration through the mucus barrier allowing for increased delivery directly to the ocular tissue. With a pH close to human tears and low preservative (BAK) level, Lotemax SM uses submicron (SM) technology for enhanced adherence to the ocular surface and subsequent wider penetration to key ocular tissues. Both products allow for greater efficacy at lower doses.
Educating patients on branded versus generic
As a proponent for branded eye drops, Dr. Singh educates his patients on the importance of the inactive ingredients and the relevance of formulation with regard to consistency in treatment results. He explained that multiple companies can make the same generic, making it difficult to determine whether you are getting the exact same drug every time.
Conversely, he emphasized that with branded products, surgeons can be confident in the quality control/assurance taken to manufacture these topical medications. If, after this conversation, the individual still opts to accept a generic substitute, Dr. Singh provides a waiver form with a checkbox indicating they have rejected the recommended branded drops.
The role of specialty pharmacies
According to the American Pharmacist Association, specialty pharmacies are those that “focus on high cost, high touch medication therapy for patients with complex disease states.” Each surgeon has located specialty pharmacies of their own volition which enable them to get their desired medication regimen in the hands of their patients.
Often specialty pharmacies will honor manufacturer’s coupons, even with Medicare patients, while big box pharmacies tend to be more inconsistent in applying these discounts. In the event the pharmacy cannot fill, or the insurance denies the prescription, most specialty pharmacies have a standing substitution list, allowing the doctor to be aware of precisely what the patient will be receiving in those unique circumstances.
In addition, using a specialty pharmacy can enhance workflow and staff burden by reducing prior authorizations.
Patient compliance
The responsibility of instilling eye drops four or more times a day is one of the most common reasons for post-surgical noncompliance. By reducing the dosage to twice a day with Inveltys or three times a day with Lotemax SM, patients are more likely to adhere to their dosing schedule. This could result in a more calculable, rapid recovery and potentially better overall surgical outcomes.
Innovations in intraoperative drug delivery: Dexycu and Dextenza
Reducing inflammation and decreasing pain are integral to post-operative success. Two of the most powerful intraoperative tools to achieve this without a topical eye drop are Dexycu and Dextenza. Both can be appropriate for stand-alone cataract surgery and in combination cataract/microinvasive glaucoma surgery (MIGS) procedures.
Dexycu (dexamethasone intraocular suspension 9%, EyePoint Pharmaceuticals) treats post-operative inflammation with a single injection given at the time of surgery. Effects may begin as early as day 1 and last for an entire month.
Indicated for both post-operative pain as well as ocular inflammation, Dextenza (dexamethasone ophthalmic insert 0.4mg, Ocular Therapeutix) is an intraocular insert that is placed into canaliculus where it delivers a tapered dose of steroids for 30 days prior to resorbing and exiting through the nasolacrimal system.
Dextenza can also decrease aqueous drainage to maintain moisture on the ocular surface, minimizing discomfort caused by dry eye. For patients with a history of ocular surface disease, Dr. Singh places inserts in the lower and upper punctum. Additionally, Dr. Radcliffe reports anecdotally fewer floaters with Dextenza compared to Tri-Moxi.
In addition, Dextenza has two CPT codes which might allow for reimbursement in qualifying situations. The procedure for insertion of Dextenza is identified using CPT code 68841, while the product J-code is J1096. Here is a list of potential ICD-10 codes associated with ocular surgery (and allergic conjunctivitis).
Benefits of Durysta
Leading up to surgery, all three doctors have utilized DURYSTA (bimatoprost intracameral implant 10mcg), a first-of-its-kind biodegradable preservative-free implant for patients with open-angle glaucoma and/or ocular hypertension that could reduce intraocular pressure (IOP) for up to several months. Implanting Durysta prior to cataract surgery allows the patient to discontinue the use of some topical agents to spare the ocular surface from further burden from preservative toxicity.
With this thought in mind, Dr. Gupta has leveraged Durysta in the perioperative setting to allow patients a temporary respite from prostaglandin analogs (PGAs).
Tips and tricks from the experts
One of the keys to the seamless implementation of these systems is to learn how to employ them using your specific surgical techniques. If you have difficulty keeping Dexycu in the sulcus, Dr. Radcliffe suggested placing it into the capsular bag off to the side of the IOL.
Using a 30 gauge needle, Dr. Radcliffe has also effectively delivered the medication into the vitreous cavity through a pars plana approach. As there is more space in the vitreous, you can deliver a higher volume of Dexycu to maximize its anti-inflammatory benefits without creating positive pressure.
When injecting Dexycu, Dr. Singh uses the intracapsular bag technique, which involves inserting the cannula containing Dexycu between the IOL and peripheral anterior capsule through a paracentesis. With this approach, the rim of the IOL and the anterior leaflet inhibit the drug sphere from migrating to the anterior chamber. Additionally, it can provide superior visualization while lowering the incidence of iatrogenic iris trauma.
For the implantation of Dextenza, Dr. Gupta introduces viscoelastic into the puncta after dilation to facilitate smooth delivery of the steroid insert.
Increasing efficiency by incorporating modern drug delivery
In addition to the other benefits, incorporating these drugs can increase practice efficiency. In a study done at his office, Dr. Singh and his colleagues looked at the time and workflow impact of removing one postoperative drop from a MIGS patient’s regimen.
They found that by decreasing one post-op drop, it saved 5 minutes per patient spent on pharmacy callbacks and patient engagement/verification. This translates to saving up to 2.5 hours on a 30-patient day.
In closing
Of note, Dr. Radcliffe reached a milestone in his practice when, on a full operating day, he was able to use many of the modern drug delivery systems to get each and every patient a form of sustained anti-inflammatory therapy. In his professional opinion, he felt this ideally guaranteed surgical outcomes by vastly reducing the risk of complications and dissatisfaction due to patient noncompliance.
In another Dr. Singh study, he polled patients who were happy with their results at 90 days, and asked the time frame in which they expected satisfaction post-operatively. The average expectation was one week. This illustrated the importance of rapid and predictable results that advanced drug delivery systems can offer.
Whether employing an advanced drug delivery platform in an eye drop or at the time of a surgical procedure, all three surgeons challenge doctors to take advantage of these advancements. Each agreed they have made a meaningful difference to their practices and overall patient surgical care.
