FDA Approves First Generic of Restasis

Restasis is a brand-name drug made by the pharmaceutical giant Allergan. It is used by millions of Americans with dry eye disease. This medication has been approved for use in the U.S. for nearly two decades. However, until February 2022, there was no approved generic product of this drug. Now, the U.S. Food and Drug Administration (FDA) has given approval to Mylan Pharmaceuticals to make the first generic version of Restasis. Please continue reading to learn more.

Are Restasis and cyclosporine the same?

Restasis is the brand name of cyclosporine; it is a commonly prescribed immunomodulator, an agent that suppresses or stimulates the immune system. Restasis contains cyclosporine ophthalmic emulsion 0.05%; It is available as eye drops in single-use vials.

Cyclosporine belongs to a group of medications called calcineurin inhibitors, a type of immunomodulator with some anti-inflammatory effects.

Ophthalmic cyclosporine is used to treat chronic dry eye disease by increasing natural tear production and decreasing ocular inflammation.

What is Restasis used to treat?

Restasis is used to treat chronic dry eye. Even though there is no cure for this condition, symptoms can be effectively managed by over-the-counter artificial tear products and prescription medications. Dry eye can occur due to various reasons, including advancing age, other eye diseases, contact lens, certain medications, and environmental factors.

Restasis was specifically developed to treat inflammation associated with keratoconjunctivitis sicca, a type of chronic dry eye condition in which cornea and other eye tissue inflammation occurs due to drying.

Tears are required to protect the front surface of the eye. Some other fucntions of tears are to protect the eyes from infections and irritants. Therefore, patients with decreased tear production are at higher risk for eye infections, eye inflammation, corneal abrasions, corneal ulcers, and vision loss in very severe cases.

Over time and with consistent use, Restasis helps increase natural tear production in the eyes and prevent the complications of chronic dry eye.

Notably, clinical trials have shown that Restasis does not increase tear production in patients who are currently using punctal plugs or taking topical anti-inflammatory drugs. If you are using any type of treatment, both over-the-counter and prescription, for dry eye, you should inform your healthcare provider before starting Restasis.

How much does Restasis cost?

Restasis is a brand-name drug for which there was no approved generic product until recently (February 2022). The average list price for Restasis is $586 per month plus any additional charges levied by the pharmacy, depending on where you purchase the medicine.

Why is the FDA-approval of the generic version of Restasis important?

Brand name Restasis and generic cyclosporine ophthalmic emulsion contain the same active ingredient and are equally effective and safe. Generic drugs are available at significantly lower prices than their brand-name counterparts. Therefore, like with most medications, Restasis generic offers better value.

With the approval of the first generic of Restasis, the FDA has shown their ongoing commitment to advancing patient access to lower-cost, high-quality generic drug products. Again, a high-quality generic drug is equally safe and effective as its brand-name counterpart.

According to the FDA news release, the approval of a Restasis generic reflects the FDA’s continued commitment to “supporting the development and expanding opportunities to bring complex generic drugs to the market with the major focus being to improve competition and help lower drug prices.”

Why did the approval for generic cyclosporine ophthalmic emulsion 0.05% take so long?

Generic medications go through rigorous drug evaluation to make sure they work as well as their brand-name counterparts. The FDA required Mylan Pharmaceuticals, the manufacturer of generic cyclosporine eye drops, to follow additional steps to ensure it was equally safe and effective as brand-name Restasis. This is because eye drops are much more complex to manufacture than oral medications.

Frequently Asked Questions

How to use Restasis?

Restasis (cyclosporine ophthalmic emulsion) comes in the form of eye drops in a single-use vial or as Restasis MultiDose. This medication should be used twice a day, at least 12 hours apart. Be careful not to let the tip of the vial come in contact with the eye, your hands, or any other surface to avoid contamination leading to infection.

What are Restasis side effects?

Many people experience temporary stinging or burning after applying Restasis. You should tell your doctor if this side effect is severe or does not go away.

How quickly does Restasis work?

It takes several months for Restasis to increase tear production. You should use Restasis twice a day, every day, to get results. Most patients notice some increase in tear production after 3 months and a significant increase in tear production after 6 months of consistent Restasis use. Individual results can vary.

How do I get Restasis cheaper?

With the FDA’s approval to Mylan Pharmaceuticals to produce the first generic version of Restasis, this medication will now be available as a lower cost, high-quality generic medication.

In addition, a BuzzRx Restasis coupon can result in significant savings on the brand-name drug. With a BuzzRx discount card, savings card, or discount coupon, brand name Restasis could cost you a fraction of retail prices at Walmart, Walgreens, Rite Aid, CVS Pharmacy, and other participating pharmacies. For the most significant discounts on Restasis, give the checkout clerk your free BuzzRx discount coupon when you drop off your prescription.

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