Combined Corticosteroid, Antibiotic, and NSAID Compounded Formulations for Postoperative Management
William Wiley, MD
Cataract and Refractive Surgeon, Cleveland Eye Clinic
LessDrops is a portfolio of combination topical, ophthalmic compounded formulations for use following LASIK, PRK, cataract, and other ocular surgeries. The three variations (see Table 1) contain combinations of the three primary classes of medications used around the time of surgery in a single bottle–a corticosteroid, nonsteroidal anti-inflammatory (NSAID), and antibiotic–which can offer patients convenience by reducing the number of drops administered daily and potential cost savings.
Proprietary SSP Technology developed by Imprimis solubilizes active pharmaceutical ingredients (APIs) that ordinarily would not mix into a predictable, well-distributed, micronized particle suspension.
Table 1: LessDrops Formulations
|Pred-Gati||Prednisolone acetate and gatifloxacin||(1/0.5)%|
|Pred-Gati-Brom||Prednisolone acetate, gatifloxacin and bromfenac||(1/0.5/0.075)%|
|Pred-Brom||Prednisolone acetate and bromfenac||(1/0.075)%|
Combined for Convenience and Cost-Benefits
Combination drugs can simplify the traditional postoperative regimen to a single bottle versus two or three medications with different tapering schedules (see Table 2). Furthermore, multiagent formulations avoid the washout effect resulting from hasty instillation of consecutive drops.
Although patients must typically pay out of pocket because most insurance companies do not cover compounded topical medications, potential cost-savings of compounding and combined medications may make the total expenditure less.1
Table 2: Example Postoperative Regimen Comparison
*Pricing based on average retail prices for branded comparables reported by GoodRx.com (accessed March 2018). Actual dosing regimen may vary.
Benefits Bestowed By 503B Pharmacies
As a 503B compounding pharmacy, Imprimis is able to make medications in bulk without patient-specific prescriptions and ship directly to surgical centers. Dispensing postoperative medications from the practice saves patients a trip to the pharmacy, eliminates pharmacy callbacks, and assures surgical staff that the patient has the proper medications.
To satisfy requirements of 503B, facilities are inspected by the FDA and manufacturing protocols must meet Current Good Manufacturing Processes (cGMP) guidelines to safeguard quality and safety. Each batch is tested for potency, sterility, and endotoxins, and continuous environmental testing is conducted to evaluate potential routes of microbial contamination that could arise from the air, surfaces, process, operation, or personnel practices.
Switching to LessDrops has been a win/win for our LASIK practice and patients. LessDrops appears to be very well tolerated, as we've noted less ocular surface changes and have had fewer dry eye complaints. Patients appreciate the convenience of receiving their medication at our office, which not only saves them from a separate trip to the pharmacy but also an average of $150 dollars when compared to our previous drop protocol.
I know for postoperative eye surgery patients, reduced compliance due to forgetfulness, inconvenience, high cost, and frequency of eye drop application can lead to serious, vision threatening problems with healing. In every way possible, I want to help address these issues for them.
I have found LessDrops to be a wonderful addition to my LASIK, SMILE, PRK, and cataract patients’ postoperative care that addresses the compliance issue in an impactful way. My patients have appreciated how affordable these drops are compared to other brands.
But for me, above and beyond affordability, has been the joy of providing a high-quality alternative ocular drop option that now has my confidence.
My confidence was gained after studying and learning about Imprimis as a company. They are a 503B FDA-registered and inspected outsourcing facility and adhere to Current Good Manufacturing Practices (cGMP). Also, on the innovative side, their Patented Surfactant Solubilizing Process (SSP) technology uniquely allows for the combination of drugs in one bottle to be highly effective and reliable. I can now give a high-quality combination of drops in 3 formulations that I find useful; a 4th generation fluoroquinolone antibiotic and steroid, a steroid and nonsteroidal, or a combination of all three. Imprimis’ philosophy of providing high-quality, innovative formulations at affordable prices, has both resonated with me and improved my patient care.
I mostly use LessDrops after cataract or refractive surgery, but also after other procedures as indicated.
The major reason I like to use LessDrops is that it is convenient for patients. One drop from one bottle delivers the medications that they need.
At the end of cataract surgery, I place Dex-Moxi-Ketor in the anterior chamber, and so these patients use LessDrops (pred-gati-brom) one drop once a day. It doesn’t get much easier than that. I also enjoy that it can be another cost-effective option for patients.
The convenience and cost-effectiveness allow for great compliance from patients. To me this is a win-win-win.
Traditional postoperative cataract drop regimens include an antibiotic q.i.d., a steroid q.i.d., and an NSAID once or twice a day. This approach is effective but does lead to issues with compliance, convenience, and cost for patients that are undergoing corneal refractive surgery, cataract, and other ocular surgeries. As I prepare a patient to undergo corneal refractive surgery or cataract surgery I like to talk to them about the 4 C’s: compliance, convenience, cost, and choice.
Convenience and Compliance: A traditional postoperative cataract drop regimen includes three bottles of medication. The problem with this approach is lack of convenience, and the amount of time throughout a day a patient or caregiver has to administer drops. A lack of convenience is ultimately linked to adverse affects on compliance.
Cost: An argument can be made that less bottles of medication equals less cost to the patient. Managed care plans for each patient will cause variability in the cost of medications and the debate will continue in regard to cost, but it is a factor that needs to be considered.
Choice: It is important when preparing a patient for corneal refractive surgery or cataract surgery that they are well educated and given a choice on the types of procedures, intraocular lenses, and technologies available. The same is true on postoperative medication choices. LessDrops has provided another option for patients that are undergoing corneal refractive surgery or cataract surgery. These drops have allowed doctors to address 4 major C’s: convenience, compliance, cost and choice.
We have used LessDrops, DropLess (injections), and the MKO Melt from Imprimis for the last 3 years. They have all been a win for our patients and our practice by decreasing costs and increasing the ease of use and ultimately improving the patient experience.
I currently use LessDrops for my LASIK and corneal refractive surgery patients. I find that by providing these cost effective, easy to use, convenient formulations to my patients at the time of surgery, I can be assured that they will receive the drugs I want them to have postoperatively. In the past, I had problems with some patients failing to fill prescriptions, inappropriate substitutions, and patient complaints of high costs with some of the drops. My staff also had to deal with calls and faxes from pharmacies, as well as patient confusion due to mislabeled prescriptions. Now that we can give LessDrops to our patients directly, our compliance rate is much better, and patients really appreciate not having the hassle or cost of filling prescriptions. We consider this a “value-added” service for our refractive surgery patients, and one that sets us apart in our market.
1. Data on file with company.
Financial disclosures: William Wiley, MD, is a consultant to Imprimis Pharmaceuticals, Inc.