Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis

The study is conducted in 2 parts: a randomized, blinded part in which subjects are assigned
randomly (by chance) to LiRIS 400 mg or LiRIS placebo; subjects who complete this part and
are eligible to continue, may participate in the open-label part in which all subjects
receive LiRIS 400 mg.

In both parts of the study (blinded and open-label), LiRIS is inserted into the bladder
during cystoscopy, remains in the bladder for 14 days, and is removed during cystoscopy. In
addition to the 14 day period with the LiRIS/LiRIS Placebo, there is a screening period of
up to 2 weeks and a follow up period of 4 weeks.

Inclusion Criteria

Blinded study:

- Women age 18 and over

- Diagnosed with Interstitial Cystitis as defined by protocol

- Able to report IC symptoms of bladder pain, voiding habits, as required by protocol,
and record in diary

- Able to comply with visit schedule and diary completion at home

Open-label Extension:

- Must have completed the blinded study prior to screening for the Open-label extension

Exclusion Criteria (Blinded and Open-Label Extension):

- Pregnant or lactating women

- History or presence of any condition that would make it difficult to accurately
evaluate bladder symptoms

- Bladder or urethral abnormality that would prevent safe insertion of investigational
product

- Requiring medication not allowed per study protocol