OR WAIT null SECS
By Laird Harrison
Rapid changes in the drug industry are affecting glaucoma practices, said Andrew G. Iwach, MD, who provided an overview of these trends. “It’s an interesting time right now.”
Among the most important trends in glaucoma medications is the rise of prostaglandins and the decline of other medications to treat glaucoma, said Dr. Iwach, displaying a graph of trend lines from IMS Institute for Healthcare Informatics. Dr. Iwach is an associate clinical professor of ophthalmology at the University of California, San Francisco.
Watch as Andrew Iwach, MD, outlines how changes in the pharmaceutical industry will affect glaucoma practices.
Ophthalmologists should take note of adverse reactions, he pointed out. Some patients develop reactions to preservatives. It’s helpful to know that multiple preparations are available, including some that don’t use the preservative benzalkonium chloride (BAK). These include preservative-free preparations of dorzolamide/timolol and tafluprost , though the manufacturers may have changed.
Dr. Iwach said he treated a patient who developed a reaction to brinzolamide/brimonidine, including an ectropion. Many similar reactions have been reported to brimonidine as well as to dorzolamide.
“The reason that I bring this up is that if you realize what’s going on, and you stop the medication, and you put a little bit of steroid, maybe cream, it goes away,” he said.
Another challenge for glaucoma specialists stems from a rise of generic drugs on the market. The patents have recently expired for many glaucoma medications. “It’s a very significant change in the prescription-writing pattern, once a molecule is no longer protected by patent,” said Dr. Iwach.
This proliferation also can create confusion. “It’s wise when you see patients to ask them to bring in the bottles and to show you what they’re actually taking,” advised Dr. Iwach.
He gave the example of a bottle of a generic timolol designed to open by screwing the cap down so that a pick opens a small hole in the seal. The instructions were not clear, and a patient, instead, snipped off the tip of the cone-shaped bottle. “The patient was running through the medication within a few days,” said Dr. Iwach.
While new generics are proliferating, the price of some older drugs has been rising. One reason is a change in the approach by the FDA, said Dr. Iwach.
The agency approved some drugs about 50 years ago based on proof of safety, not efficacy, because they were already in use in 1962 when the agency first began requiring proof of efficacy.
Now, the FDA offers drug companies exclusive rights to sell these drugs if the companies can prove efficacy.
Pilocarpine has risen in price since Alcon Laboratories and Sandoz (both subsidiaries of Novartis) invested about $2 million in proving its efficacy, Dr. Iwach said.
The FDA plans to accelerate this process. “They’re trying to hire more people to get this going even faster,” added Dr. Iwach
He listed homatropine ophthalmic solution, scopolamine ophthalmic solution, atropine ophthalmic solution, lissamine green ophthalmic solution and strips, rose bengal ophthalmic solution and/or strips, fluorescein ophthalmic drops and/or strips, tetracaine ophthalmic solution and phenylephrine ophthalmic solution as possible candidates for the same process. “So if you’re wondering about access or costs, this is part of the story as to what is the force behind that,” he said.
Ophthalmologists can help patients navigate this shifting landscape. Dr. Iwach mentioned GoodRx, a website and smartphone application, that allows users to compare different prices for the same drug charged by pharmacies in their area.
“As patients are being asked to pay more out of pocket, these are some of the tools we can use to help them make the right decisions,” he said.
New drug delivery systems also may help patients. For example, Ocular Therapeutix has formulated travoprost as a small plug that can be inserted through a duct in the eyelid. The travoprost is slowly released.
“(Patients) would come into the office and you could put one of these in and that would take care of some of the compliance issues,” he said. “In the 2-month data, it looks pretty promising.”
Dr. Iwach showed a graph in which IOP dropped about 7 mm Hg within the first two weeks. Hyperemia appeared quite low as well.
The approach may lend itself to drugs that can’t be used now because of the high risk of side effects.
“If you even dose once a day, you have to get it up to a peak dose to cover the trough,” he said. “But if you’re slowly percolating drug like a drip system in a garden, then you can avoid those high peak doses. By lowering the concentration, you can reduce side effects. So that’s hopeful for the future.”