Restasis Vs. Cequa: Summary Of Their Differences

Sidney asked

I went to my doctor to get treated for my chronic dry eyes and though he was going to talk to me about Restasis. Instead, he suggested Cequa. Can you tell me the difference between them?

Answer

Both Cequa (pronounced See-Kwah) and Restasis are similar in that they are used to treat chronic dry eyes by reducing inflammation and restoring your ability to naturally produce tears. They even contain the same active ingredient, cyclosporine.

They do have some differences though, with perhaps the most notable being that Cequa contains a higher concentration of cyclosporine (0.09%) than Restasis (0.05%).

Other differences include how they are formulated (e.g. one is a solution and the other is an emulsion) and their cost. I'll describe these in more detail below.

Differences

The next sections contain a general overview of the differences between Cequa and Restasis and cover:

• Concentration
• Side Effect Profile
• Effectiveness
• Formulations
• Packaging
• How To Use
• Cost

Concentration

As stated, both Cequa and Restasis contain cyclosporine, an immunosuppressive/anti-inflammatory agent, but in different concentrations:

• Restasis (cyclosporin 0.05%)
• Cequa (cyclosporin 0.09%)

Whether this increased concentration of cyclosporine contained in Cequa translates to it being more effective in treating dry eyes isn't definitively known.

There are no head-to-head or comparison studies to draw from, unfortunately. I do discuss their clinical trial data in one of the following sections, however.

Formulation

While both Restasis and Cequa are in liquid dosage forms, they are formulated differently:

• Restasis is an emulsion
• Cequa is a solution

There likely isn't a huge difference in effect based on the type of formulation used alone.

Nevertheless, the manufacturer of Cequa, Sun Pharma, in a news release, stated this regarding their formulation in particular:

"...[Cequa] is the first and only approved CsA [cyclosporin] product that incorporates a nanomicellar technology. The innovative nanomicellar formulation allows the CsA molecule to overcome solubility challenges, penetrate the eye’s aqueous layer and prevents the release of the active lipophilic molecule prior to penetration."

What this is basically saying is that Cequa is formulated in a way that allows the drug (cyclosporine) to be delivered to the site of action (corneal and conjunctival cells) without significant degradation or loss of active ingredient in other parts of the eye. This feature is one of its (Cequa) main marketing claims.

There is no indication, however, that Cequa delivers a higher percentage of cyclosporine to the site of action when compared to Restasis.

The full ingredient list for each drug is as follows:

Restasis

• Cyclosporine 0.05%
• Glycerin
• Castor oil
• Polysorbate 80
• Carbomer copolymer type A
• Purified water
• Sodium hydroxide

Restasis appears as a white opaque to slightly translucent homogeneous emulsion.

Cequa

• Cyclosporine 0.09%
• Polyoxyl hydrogenated castor oil
• Octoxynol-40
• Polyvinylpyrrolidone
• Sodium phosphate monobasic dihydrate
• Sodium phosphate dibasic anhydrous
• Water for injection
• Sodium hydroxide
  

Cequa appears as a clear, colorless ophthalmic solution.

Packaging

How these drugs are packaged and available to consumers represents a significant difference between two.

Firstly, both are available as single-use, preservative-free vials. However, Cequa contains a lower volume of liquid:

• Cequa contains 0.25 mL liquid per single-use vial.
• Restasis contains 0.4 mL liquid per single-use vial.

So, the vial the liquid comes in for each product is the same size (0.9 mL), but Cequa contains less liquid.

Below are excerpts from each of their respective prescription information inserts:

Restasis:

RESTASIS® ophthalmic emulsion is packaged in sterile, preservative-free single-use vials. Each vial contains 0.4 mL fill in a 0.9 mL LDPE [Low-density polyethylene] vial.

Cequa:

CEQUA ophthalmic solution is packaged in sterile, preservative-free, single-use vials. Each vial contains 0.25 mL fill in a 0.9 mL LDPE vial.

It is important to note that while Restasis was originally only available as single-use vials (as described above), it now is also available in a 'MultiDose' bottle.

Just like the single-use vials, the MultiDose bottle contains no preservatives. One bottle contains a one-month supply. The MultiDose bottle looks like this:

If you find single-use vials cumbersome (and wasteful due to the plastic packaging), the MultiDose bottle may be a better option for you.

Cequa is only available in single-use plastic vials. It does not come in a Multi-use bottle like Restasis.

Effectiveness

Both Restasis and Cequa use the same data endpoint in their clinical trials for determining the effectiveness of each. The test they use is known as the 'Schirmer wetting test'

The 'Schirmer wetting test' is used to determine whether or not your tear glands produce enough tears to moisturize the eyes.

To perform the test, a calibrated, vertical paper strip inserted into the lower eyelid of each eye. The eyes are then closed for 5 minutes and the amount of moisture that has traveled down the strip (from the eye) is measured.

The benchmark for 'normal' moisture production is 10 mm of moistened paper (i.e. moisture from tear production has traveled 10 millimeters down the paper strip from the eye).

If less than 10mm of the paper has been moistened, you likely have some sort of problem producing tears and may be diagnosed as having dry eye syndrome.

So, how Cequa and Restasis measure effectiveness is by reporting how many individuals who 'failed' the Schirmer wetting test (by producing less than 10mm of moisture) improved to producing over 10mm of moisture after using the respective drug.

Cequa Effectiveness

The following is reported from the prescribing information for Cequa:

To put this data into words:

• In the first clinical trial (OTX-101-2014-001), 16.8% of individuals who previously had less than 10mm of tear production (via the Schirmer test) now produced over 10mm after 84 days of use of Cequa. This compares to only 8.6% of individuals who used the drug vehicle alone (i.e. non-drug containing liquid). This represents an 8.2% difference between Cequa and placebo (i.e. vehicle).


• In the second clinical trial (OTX-101-2016-001), 16.6% of individuals who previously had less than 10mm of tear production (via the Schirmer test) now produced over 10mm after 84 days of use of Cequa. This compares to only 9.2% of individuals who used the drug vehicle alone (i.e. non-drug containing liquid). This represents a 7.3% difference between Cequa and placebo (i.e. vehicle).

Restasis Effectiveness

The prescribing information for Restasis doesn't provide a chart summarizing their clinical trial data as Cequa does. It does, however, state: