New glaucoma drug approved by FDA. It’s been called the “silent thief of sight” because it causes gradual vision loss over a long time. By the time you notice the symptoms, the disease is quite advanced and even with treatment, ten percent of sufferers still end up blind.
It’s glaucoma, and it’s the second leading cause of blindness globally, after cataracts, affecting one in 200 people aged 50 and younger—with that number rising to one in 10 for people over the age of eighty.
Over 60.5 million people worldwide and 120,000 Americans have glaucoma and by 2020, ophthalmologists estimated that their numbers will rise to 79.6 million. The numbers in China and India are bigger, and the disease is a leading cause of blindness among African Americans.
But glaucoma presents a great public health challenge because the blindness it causes is irreversible. Worse, only half of the people who have glaucoma know that they have it.
Treatment is aimed at further preventing further vision loss. But if the condition is detected early enough, it’s possible to arrest the development or slow the progression with medical and surgical means.
Ocular hypertension (increased pressure within the eye) is the most important risk factor in most glaucomas, and the key to treatment is keeping the eye pressure within normal bounds.
On Feb. 14, the U.S. Food and Drug Administration approved a new solution to treat this common but deadly eye condition.
The drug, manufactured by pharmaceutical giant Merck & Co is called Zioptan, whose active ingredient is tafluprost. It’s previously been approved for use in certain European countries under the brand Saflutan.
Zioptan treats ocular hypertension. Patients with ocular hypertension frequently are considered to have a greater chance of developing glaucoma.
The drug is also approved to treat elevated intraocular pressure in people with a form of glaucoma known as open-angle. This form of glaucoma, the most common form of the disease, involves mounting pressure on the optic nerve.
Zioptan is a prostaglandin analog ophthalmic solution. Most solutions like this use preservatives that are linked to side effects. But Merck claims Zioptan is the first preservative-free prostaglandin analog ophthalmic solution.
“Zioptan’s approval provides an alternative treatment option for patients living with this potentially blinding disease,” says Dr. Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research.
“Prostaglandin analogs are often used as a first line of treatment to lower intraocular pressure in patients with open-angle glaucoma. The approval of Zioptan will provide a new, effective option to lower IOP,” says Dr. George L. Spaeth of the Wills Eye Institute in Philadelphia. “I anticipate using Zioptan in many of these patients in my practice,” he says in a company press release.
FDA approved Zioptan based on the efficacy and safety results of five controlled clinical studies that enrolled 905 patients for up to two years. Both preservative-containing and preservative-free formulations of tafluprost were used in these clinical studies.
In clinical studies of up to two years long, patients with open-angle glaucoma or ocular hypertension treated with Zioptan in the evening showed reduced eye pressure at three and six months.
Particularly, pressure was reduced by 6-8 mmHg at three months and by 5-8 mmHg at six months, from a baseline pressure of 23-26 mmHg. Eye pressure is measured in millimeters of mercury (mm Hg), a measure of fluid pressure in the eye. Normal eye pressure ranges from 10-21 mm Hg. If pressure is greater than 21 mm Hg, it’s considered to beocular hypertension.
Beginning this March, Merck expects Zioptan to become available to U.S. consumers, priced at US$97 for a 30-day supply, a company spokeswoman told the Wall Street Journal.
Because Pfizer Inc’s Xalatan eye solution recently lost market exclusivity in major countries, clearing the way for cheaper generic copies, so Zioptan enters a market with generic options.
Trusopt and Cosopt, two of Merck’s older drugs designed to reduce intraocular pressure have also lost market exclusivity in the U.S. and some other countries.
The drug was developed in cooperation with specialist drug maker Santen Pharmaceutical, an Osaka, Japan-based company that specializes in ophthalmic and anti-rheumatic fields.
Zioptan Dos and Don’ts
Before using Zioptan
DO tell your doctor if you:
• have or have had eye problems including any surgery on your eye or eyes
• are using any other eye medicines
• have any other medical problems
• are pregnant or plan to become pregnant. It isn’t known if Zioptan will harm your unborn baby.
• if you are breastfeeding or plan to breastfeed. It isn’t known if Zioptan passes into your breast milk.
• if you become pregnant while using Zioptan
• about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
DO know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
DON’T use Zioptan for
• people who have active intraocular inflammation (e.g., iritis/uveitis) because the inflammation may be worstened
• people who have macular edema, including cystoid macular edema. And it should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
When taking Zioptan
An eye drop, Zioptan should be used once daily in the evening.
• DO know that Zioptan is for the eye only. DON’T swallow Zioptan.
• DO know that Zioptan single-use containers are packaged in a foil pouch.
• DON’T use the Zioptan single-use containers if the foil pouch is opened.
• DO write down the date you open the foil pouch in the space provided on the pouch.
How to take Zioptan
DO talk to your doctor or pharmacist if you are not sure how to use Zioptan.
DO use one drop of Zioptan in your eye (or eyes) each evening.
Your Zioptan may not work as well if you use it more than one time each evening.
If you use other medicines in your eye, DO wait at least five minutes between using Zioptan and your other eye medicines.
DO use your Zioptan right away after opening. Each Zioptan single-use container is sterile and is to be used one time then thrown away.
DON’T save any Zioptan that may be left over after you use your medicine.
DO know that using Zioptan that isn’t sterile may cause other eye problems.
Every time you use Zioptan DO take the following 10 steps:
1. Wash your hands.
2. Take the strip of single-use containers from the foil pouch.
3. Pull off one single-use container from the strip.
4. Put the remaining strip of single-use containers back in the foil pouch and fold the edge to close the pouch.
5. Hold the single-use container upright. Make sure that your Zioptan medicine is in the bottom part of the single-use container.
6. Open the single-use container by twisting off the tab.
7. Tilt your head backwards. If you are unable to tilt your head, lie down.
8. Place the tip of the single-use container close to your eye. Be careful not to touch your eye with the tip of the single-use container.
9. Pull your lower eyelid downwards and look up.
10. Gently squeeze the container and let 1 drop of Zioptan fall into the space between your lower eyelid and your eye. If a drop misses your eye, try again.
11. If your doctor has told you to use Zioptan drops in both eyes, repeat Steps 7 to 10 for your other eye.
DO know that there’s enough Zioptan in one single-use container for both of your eyes.
DO throw away the opened single-use container with any remaining Zioptan right away.
Zioptan Side Effects: Serious
• Changes in the color of your eye (iris). DO know that you iris may become more brown in color while using Zioptan. This color change may not go away when you stop using Zioptan. If Zioptan is used in one eye only, the color of that eye may always be a different color from the color of your other eye. Iris color change may not be noticeable for several months to years. DO KNOW that the drug maker says the long term effects of increased pigmentation are not known, so while treatment with Zioptan can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.
• Changes in the color of the skin around your eye. DO know the darkening of the color of the skin around your eye (eyelid). But these skin changes usually go away when you stop using Zioptan.
• Increases in the length, thickness, color, or number of your eyelashes. DO know that these eyelash changes usually go away when you stop using Zioptan.
• Hair growth on your eyelids. DO know that this hair growth usually goes away when you stop using Zioptan.
Zioptan Side Effects: Common. DO know that the most common side effects of Zioptan include:
• redness, stinging or itching of your eye
• cataract formation
• dry eye
• eye pain
• blurred vision
• common cold
• urinary tract infection
DO tell your doctor if you have any new eye problems while using Zioptan including:
• an eye injury
• an eye infection
• a sudden loss of vision
• eye surgery
• swelling and redness of and around your eye (conjunctivitis)
• problems with your eyelids
DO tell your doctor if you have any other side effects that bother you.
DO know that these are not all the possible side effects of Zioptan.
DO ask your doctor or pharmacist.
DO call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA¬ 1088.
DO keep the foil pouches and Zioptan single-use containers dry.
Before opening the foil pouches:
• DO Store the unopened foil pouches in a refrigerator between 36°F to 46°F (2°C to 8°C).
• DON’T open the pouch containing Zioptan until you are ready to use the eye drops.
After opening the foil pouch:
• DO store the opened foil pouch at room temperature, between 68°F to 77°F (20°C to 25°C), for up to 28 days.
• DO throw away all unused Zioptan single-use containers in the opened foil pouch after 28 days.
DO Keep the Zioptan single-use containers in their original foil pouch.
DO know that after opening the foil pouch, refrigeration isn’t required.
DO Keep Zioptan and all medicines out of the reach of children.