News on cataract surgery medications centers on intraocular preparations

Take home

In terms of medication use in cataract surgery, ophthalmologists discussed the continued increasing use of the intracameral route for antibiotic administration to prevent endophthalmitis and the launch of the “Go Dropless” campaign.

By Cheryl Guttman Krader; Reviewed by Randall J. Olson, MD, and Mark Packer, MD

In 2014, ophthalmology saw the approval of one new medication for use in cataract surgery-the fixed combination of phenylephrine 1% and ketorolac 0.3% (Omidria, Omeros) for intraoperative use by addition to the irrigation solution.

Otherwise, the most noteworthy item in terms of medication use in cataract surgery is probably the continued increasing use of the intracameral route for antibiotic administration to prevent endophthalmitis and the launch of the “Go Dropless” campaign using products from specialty pharmaceutical company, Imprimis Pharmaceuticals.

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Ophthalmology Times editorial advisory board members, Randall J. Olson, MD, and Mark Packer, MD, discussed these topics.

Dr. Olson and Dr. Packer both observed that use of intracameral antibiotics for endophthalmitis prophylaxis is growing among American cataract surgeons. Dr. Olson said that more and more surgeons at his institution are using the intracameral route of antibiotic administration as their standard approach, and he predicted it would become the predominant technique in the United States if a reasonably priced, unit-dose antibiotic for intracameral use became available.

While there is ongoing discussion about creating an easier pathway for gaining FDA approval of such a product, no changes appear imminent. Meanwhile, many surgeons remain wary about using intracameral antibiotics, and with good reason, Dr. Olson said.

Noting that cases of TASS associated with use of intracameral antibiotics continue to occur, Dr. Olson cautioned surgeons using the technique to be careful.

“Know that it is easy to make a mistake in the preparation and that compounding pharmacies do not have a good track record,” said Dr. Olson, professor and chairman, Department of Ophthalmology and Visual Sciences and chief executive officer, John A. Moran Eye Center, University of Utah, Salt Lake City.

Dr. Packer also believes that concerns about TASS, microbial contamination, and preparation errors with use of products obtained from compounding pharmacies has been a major deterrent to more widespread use of intracameral antibiotics among American cataract surgeons. Therefore, he also urged surgeons using the technique to be cautious in choosing a source for obtaining a compounded intracameral antibiotic.

That said, Dr. Packer noted he has been using the intracameral approach for endophthalmitis prophylaxis with off-the-shelf moxifloxacin 0.5% (Vigamox, Alcon). However, he told Ophthalmology Times that he is about to try “dropless” cataract surgery using a compounded combination formulation of moxifloxacin and triamcinolone that is available from Imprimis Pharmaceuticals. Each dose is ordered online on an individual patient basis and then shipped directly to the surgeon. Imprimis Pharmaceuticals also sells a combination formulation of moxifloxacin, vancomycin, and triamcinolone. However, Dr. Packer said he would avoid that preparation due to concerns about promoting bacterial resistance to vancomycin.

The combination products are suspension formulations and administered using a unique delivery system in a transzonular approach, the idea being that the medication diffuses into the vitreous where it will have a longer half-life than after intracameral injection

“This was the ‘big thing’ I learned about at the AAO meeting this year, and I talked to a number of surgeons who are using it and subsequently abandoned all perioperative topical drops,” said Dr. Packer, who is in private practice, Boulder, CO, and clinical associate professor of ophthalmology, Oregon Health & Science University, Portland.

“They say that perhaps 1 or 2 patients out of 100 develop a rebound inflammatory reaction at 3 weeks and are then started on a topical steroid for a few weeks,” he said. “I have also heard that the suspension may cause transient fuzzy vision in patients with multifocal IOLs. However, these are the only issues they have encountered so far when using the dropless technique.”

He noted that the timing of Imprimis Pharmaceuticals’ “Go Dropless” campaign seems to be good considering that according to results of the 2014 ASCRS clinical survey, about half of U.S. cataract surgeons are using some form of intracameral antibiotic.

“In the 2007 survey when this question was first asked, 14% of surgeons said they were using an intracameral antibiotic. So, it is pretty clear from the recent data that the technique is catching on,” Dr. Packer said.

However, he remained doubtful that there would ever be an FDA-approved intracameral antibiotic unless the regulatory agency decides to bend or change its rules.

“Since postoperative endophthalmitis is so rare, a controlled, randomized trial would have to enroll more than 250,000 subjects to demonstrate superiority of the investigational agent, and that is not going to happen.”

Phenylephrine-ketorolac combination

Dr. Olson said the fixed combination of phenylephrine and ketorolac is an interesting new product that was demonstrated effective for preventing miosis and reducing postoperative pain in placebo-controlled pivotal trials. Broader understanding of its utility is pending further experience and will take some time because the product is not being launched until 2015.

“There is discussion that this fixed combination may be particularly useful in cases where there is concern about intraoperative floppy iris syndrome (IFIS), and that makes sense,” Dr. Olson said. “However, we don’t have any information about its use in that scenario.”

Dr. Packer said he expects the phenylephrine-ketorolac combination to be a valuable addition for selected cases where surgeons would use an intraocular alpha-agonist for mydriasis, particularly considering the unavailability of preservative-free epinephrine.

“Intracameral use of preservative-free epinephrine has been our go to strategy for maintaining pupil dilation in eyes where IFIS is a concern,” Dr. Packer said. “However, that medication has been impossible to get, and surgeons have been forced to find some work around. The fixed combination of phenylephrine-ketorolac seems to be a good option because it is labeled for intraocular administration and is easy to use.”

He also noted that there are no studies using the product specifically in IFIS.

“Clearly, however, it is effective for dilating a normal pupil and keeping it open during surgery,” Dr. Packer added. “Therefore, I expect it should be helpful with IFIS.”

He pointed out that as another alternative for addressing the shortage of preservative-free epinephrine, the following products are available from Imprimis Pharmaceuticals: lyophilized preservative-free and sulfite-free epinephrine, lyophilized preservative-free and sulfite-free combination of epinephrine and lidocaine (i.e., “Shugarcaine”); and lyophilized preservative-free and sulfite-free combination of phenylephrine and lidocaine.

Randall J. Olson, MD

E: randallj.olson@hsc.utah.edu

Dr. Olson has no relevant financial interests to disclose.

Mark Packer, MD

E: mark@markpackerconsulting.com

Dr. Packer is a consultant to Alcon Laboratories, Allergan, and Bausch + Lomb.