Allergan's response about storing Restasis....

[kitty]

This is the response I got from Allergan when I asked why it was recommended that Restasis be stored at room temperature. I asked if refrigeration had any impact on the stability of the product:
__________________________________________________ __________
Thank you for your interest in ALLERGAN and RESTASIS® (cyclosporine
ophthalmic emulsion) 0.05% Sterile, Preservative-Free. RESTASIS®
ophthalmic emulsion is indicated to increase tear production in patients
whose tear production is presumed to be suppressed due to ocular
inflammation associated with keratoconjunctivitis sicca. Increased tear
production was not seen in patients currently taking topical
anti-inflammatory drugs or using punctal plugs.

You had an inquiry regarding the storage and stability of this product.
As stated in the package insert, the product is stable (effective and
safe to use) until the expiration date listed on the product container
when stored at room temperature between 15º-25ºC (59-77ºF).

All of our products must also pass stability testing at 30ºC (86ºF) for
one year and 40ºC (104ºF) for 6 months. Finally, all products must
remain stable after 3 freeze-thaw cycles. If a product does not pass all
of these specifications, a statement in the package insert will note the
specific limitation of that product.

If we can be of further assistance to you, please feel free to contact
us at (800) 433-8871.

Sincerely,

Medical Information Services
Medical Affairs
Allergan, Inc.
Irvine, CA

[calli66]

Thanks for the info Kitty-

But I still wonder....

Manufacturer's statement:

All of our products must also pass stability testing at 30ºC (86ºF) for
one year and 40ºC (104ºF) for 6 months. Finally, all products must
remain stable after 3 freeze-thaw cycles. If a product does not pass all
of these specifications, a statement in the package insert will note the
specific limitation of that product.

This statement still does not specify to what extent Restasis failed. We still don't know if it's the temperature range within which time period.

C66 (just being skeptical)

[kitty]

If I interpret this correctly, it would appear that because Restasis is to be stored at room temperature, it must have failed any or all of the three.