Glaucoma eye drops: choices, choices

Take Home Points

In the preceding section, we dealt with the general issue of taking eyedrops. This section will deal with the individual drop types: which might be better for you, in what order, their strengths and weaknesses, the brand names and generics, and the elephant in the room: cost.

The Food and Drug Administration is a government agency that lists its purpose as protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products and medical devices. Any eye drop that needs a prescription and any device that is used during surgery to lower eye pressure has been checked by the FDA committees and certified. Here’s the process as outlined in their web site: Drug companies seeking approval to sell a drug in the United States must test it. First, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in humans is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit. The company then sends the data to the FDA’s Center for Drug Evaluation and Research (CDER) to review if the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale.

Patients often point out to me that they can get “great drugs” in Europe when they visit relatives, or from Asian countries. Some areas of the world have similarly rigorous safety and standardization systems as in the U.S. Some not so much. When studies were done of prostaglandin drugs sold in India, some contained the drug, others didn’t, and often the amount wasn’t what the label said. The same was true for beta blocker eye drops sold outside the U.S.A. Our approval and oversight system may be slower than elsewhere, but it makes it more likely that you are receiving what you pay for and that drugs have been tested to be safe and effective.

When drug companies develop a new drug, they get a patent to be the only ones to sell it for several years. After the patent ends, theoretically anyone can make the product as a generic drug. The usual reason they do this is to sell it in competition with the brand name drug at a lower price. Generic drugs are approved by the FDA in a less detailed way than the brand name (under patent) drug. The generic maker must present data to show it has the same identity, strength, quality, purity and bioequivalence as the brand name drug. However, for eye drops that does not necessarily mean that the generic was tested on human eyes to see if it lowers IOP as well as the brand, nor that the slightly different formulation used in the generic eye drop won’t lead to different side effects. Generic drugs sold in the USA must be manufactured in plants that are inspected and approved by the FDA, even when the factory is outside the USA. In general, generic drugs do pretty well. One recent study of 38 generic heart pills found them to be fine compared to name brands. Part of the reason is that the brand name company usually produces a generic, too, as soon as the patent runs out—they figure they’ll make some of the money in the lower price market, too.

It is left to academic groups like our Center of Excellence to test generic eye drops (at our own expense) or to follow closely what happens to patients who switch to generics. Your drug plan may try to switch you, they may demand that the doctor state that you can only use the brand name, or they may offer the brand name at a higher cost to you. We are unaware of a really bad outcome for the large groups of glaucoma patients that have switched to generic beta blockers, carbonic anhydrase inhibitors, or alpha agonists during the last 10 years. There are patients who firmly want to stay with the brand name they have been using. There’s nothing wrong with continuing the brand name, if you can afford it.

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