Positive outcomes were achieved in a clinical evaluation of proprietary compounded topical corticosteroid-antibiotic combination products for treatment after LASIK.
Take-home message: Positive outcomes were achieved in a clinical evaluation of proprietary compounded topical corticosteroid-antibiotic combination products for treatment after LASIK.
By Cheryl Guttman Krader; Reviewed by William F. Wiley, MD
Cleveland-Proprietary compounded topical corticosteroid-antibiotic combination products (LessDrops, Imprimis Pharmaceuticals) are safe and effective for postLASIK medical management, according to William F. Wiley, MD.
In addition, they provide cost and convenience advantages compared with standard regimens using individual agents, said Dr. Wiley, medical director, Cleveland Eye Clinic and its affiliated laser center, Clear Choice Custom LASIK Center, Cleveland.
Dr. Wiley evaluated the use of compounded prednisone acetate-moxifloxacin HCl (Pred-Moxi, Imprimis Pharmaceuticals) and compounded triamcinolone acetonide-moxifloxacin HCl (Tri-Moxi, Imprimis Pharmaceuticals) in a series of 60 patients who underwent LASIK.
The typical dosage for the "less drops" technique was q.i.d. for 1 week and then b.i.d. for an additional week. With that said, some patients only required 1 week of drops at the q.i.d. level, whereas others had the additional week of b.i.d. drops.
Follow-up examination and patient reports showed outcomes were similarly favorable with both formulations, and clinically, the patients’ course was indistinguishable from that of patients using traditional single-agent drops.
Evaluations included measurement of refraction and visual acuity on the first day postoperatively and at 1 week after surgery. At 1 week, uncorrected visual acuity was 20/15 or better in 47% of eyes and 20/20 or better in 82%.
“Most importantly, our assessments showed that the compounded products did what they were supposed to in terms of controlling inflammation and preventing infection,” Dr. Wiley said. “In addition, they were safe and well-tolerated.
“Some topical medications will cause burning or stinging on instillation, or they may be slightly toxic to the corneal epithelium, which could potentially decrease the ‘wow’ effect of LASIK surgery,” he said. “Patients using the compounded combination products did not complain of discomfort or irritation, and there was no evidence of delayed healing or visual recovery.”
Dr. Wiley said he had been using the proprietary compounded intravitreal corticosteroid-antibiotic products from Imprimis (Dropless Therapy) at the end of cataract surgery and was pleased with that experience.
“The ability to avoid drops after surgery was a big advantage and made me think a topical fixed combination of an antibiotic and corticosteroid would be an attractive option for patients to use after LASIK,” he said.
Although such a product would not eliminate the need for drops, it would cut the number of administrations in half, which would ease the treatment burden on patients and reduce the risk of inadvertent trauma to the flap, he noted.
As another benefit, since the drops are ordered directly from the manufacturer and shipped to the surgery center, their use ensures that all patients will be ready to start their postoperative medications after surgery.
“Some patients will not have obtained their medications when they arrive for LASIK, perhaps because they failed to fill the prescription due to cost or insurance issues or because they misunderstood and thought we would be providing the medications to them as part of the surgical package,” Dr. Wiley said.
“Use of the compounded combination drops avoids any confusion,” he said. “In addition, it offers a value-added service. Patients appreciate the convenience of getting the drops at the surgery center, and every little thing helps in today’s highly competitive LASIK marketplace.”
The compounded combination product is also priced attractively at just around $50 per bottle. Dr. Wiley noted that translates into a significant cost savings as patients often pay more than that amount for just one of the medications they need.
Based on the favorable outcomes of his evaluation, Dr. Wiley said he is transitioning to use of the compounded corticosteroid-antibiotic combination routinely for his LASIK patients.
However, he acknowledged that his evaluation was an informal assessment and that a more rigorously designed clinical trial would be needed to better understand how the two formulations compare with each other and with use of traditionally used single-agent regimens.
Imprimis Pharmaceuticals planned to begin fulfilling prescription orders for the topical corticosteroid-antibiotic formulations by the end of February, according to a prepared statement by the company.
William F. Wiley, MD
Dr. Wiley has received compensation as a consultant to Imprimis Pharmaceuticals.