ISTA Pharmaceuticals Receives FDA Approval For BROMDAY™
 
(19 Oct 2010)ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), announced the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for BROMDAY™ (bromfenac ophthalmic solution) 0.09% as a once-daily prescription eye drop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction. ISTA expects to launch BROMDAY (formerly referred to as XiDay) prior to the end of 2010.
 
"BROMDAY is the only once-daily ophthalmic nonsteroidal anti-inflammatory drug (NSAID) for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction. We believe the convenience of a once-daily eye drop will help with treatment compliance and benefit patients recovering from cataract surgery," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA. "BROMDAY is an important addition to our growing prescription eye and allergy product portfolio. Within just a few weeks, our expanded sales force will be ready to promote BROMDAY to U.S.-based ophthalmologists, along with BEPREVE®, our recently launched eye drop for the treatment of itching associated with allergic conjunctivitis.
 
"Since the BROMDAY approval process required additional clinical investigations beyond those conducted for the original approval of XIBROM™ 0.09%, we are seeking a three-year exclusivity period under the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act. BROMDAY represents a significant step in extending our successful bromfenac-based product line established when we launched XIBROM, our twice-daily NSAID for use following cataract surgery, in 2005. In addition, we are evaluating a new formulation and lower concentrations of bromfenac called REMURA™ for the potential treatment of dry eye which is now in Phase 3 clinical studies. Beginning in mid-November, we will begin detailing BROMDAY to ophthalmologists; we expect to discontinue the twice-daily XIBROM product in early 2011."
 
ABOUT BROMDAY
 
BROMDAY is a once-daily eye drop formulation of a nonsteroidal anti-inflammatory compound for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction. BROMDAY is approved for dosing once-daily beginning one day prior to surgery, on the day of surgery and continuing for the first 14 days after surgery. Since 2005, ISTA has marketed XIBROM (bromfenac ophthalmic solution)® 0.09% in the U.S. for twice-daily use for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract surgery. ISTA acquired U.S. ophthalmic rights to bromfenac in May 2002 under a license from Senju Pharmaceuticals Co. Ltd. XIBROM is the 2010 dollar market share leader in the $335 million U.S. ophthalmic nonsteroidal anti-inflammatory market. ISTA reported XIBROM net sales of $81.1 million for the year ended December 31, 2009, and net sales of $41.4 million in the first six months of 2010, up 22% over the first six months of 2009.
 
INDICATIONS AND USAGE
 
BROMDAY is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.
 
DOSAGE AND ADMINISTRATION
 
Instill one drop into the affected eye(s) once-daily beginning 1 day prior to surgery, continued on the day of surgery and through the first 14 days post-surgery.
 
DOSAGE FORMS AND STRENGTHS
 
Topical ophthalmic solution: bromfenac 0.09%
 
CONTRAINDICATIONS
 
None
 
WARNINGS AND PRECAUTIONS
 
-- Sulfite Allergic Reactions
 
-- Slow or Delayed Healing
 
-- Potential for cross-sensitivity
 
-- Increased bleeding of ocular tissues
 
-- Corneal effects including keratitis
 
-- Contact Lens Wear
 
ADVERSE REACTIONS
 
The most commonly reported adverse reactions in 2-7% of patients were abnormal sensation in the eye, conjunctival hyperemia and eye irritation (including burning/stinging).
 
FORWARD-LOOKING STATEMENTS
 
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. Without limiting the foregoing, but by way of example, statements contained in this press release related to the expected launch of BROMDAY in 2010, ISTA’s anticipated devotion of resources toward the marketing of BROMDAY and BEPREVE, ISTA’s intention to discontinue marketing and selling Xibrom in 2011, the potential exclusivity for BROMDAY under the Drug Price Competition and Patent Term Restoration Act, and the completion of Phase 3 studies for REMURA (bromfenac ophthalmic solution for dry eye), are forward-looking statements. Except as required by law, ISTA disclaims any intent or obligation to update any forward-looking statements. These forward-looking statements are based on ISTA’s expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially. Important factors that could cause actual results to differ from current expectations include, among others, delays and uncertainties related to the FDA or other regulatory agency approval or actions and such other risks and uncertainties as detailed from time to time in ISTA’s public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTA’s Annual Report on Form 10-K for the year ended December 31, 2009, and its Quarterly Report on Forms 10-Q for the quarters ended March 31 and June 30, 2010.
 
Source: ISTA Pharmaceuticals, Inc

BROMDAY

Indication(s):

Post-operative inflammation and reduction of ocular pain following cataract extraction.

Pharmacology:

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2.

Clinical Trials:

Clinical efficacy was evaluated in three, randomized, double-masked, placebo-controlled trials in which patients requiring cataract surgery were assigned to Bromday or placebo. Patients were dosed with one drop per eye starting the day before surgery and continuing for 14 days. The primary endpoint was clearing of ocular inflammation by day 15. An additional efficacy endpoint was the number of patients who were pain free on day 1 after cataract surgery.

In two of the three studies, Bromday ophthalmic solution had statistically significant higher incidence of completely clearing inflammation (46–47% vs. 25–29%) and also had a statisitically signficant higher incidence of subjects that were pain free at day 1 post cataract surgery (83–89% vs. 51–71%).

Legal Classification:

Rx

Adults:

≥18yrs: 1 drop in affected eye(s) once daily starting 1 day before surgery, continued on day of surgery, and for 14 days post-op. May be given with other topical ophthalmics (eg, alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, mydriatics); administer at least 5 minutes apart.

Children:

<18yrs: not recommended.

Warnings/Precautions:

Bleeding tendencies. May slow or delay wound healing. Complicated/repeat ocular surgeries. Corneal defects/denervation. Ocular surface diseases. Rheumatoid arthritis. Diabetes. Monitor cornea; discontinue if corneal epithelial breakdown occurs. Risk of corneal adverse events may be increased if used >24hrs before surgery, or beyond 14-days post-op. Contact lenses (remove during therapy). Pregnancy (Cat.C; avoid during late pregnancy). Nursing mothers.

Interaction(s):

Concomitant topical corticosteroids may potentiate healing problems. Caution with concomitant drugs that prolong bleeding time.

Adverse Reaction(s):

Ocular effects (eg, abnormal sensation, conjunctival hyperemia, burning, stinging, pain, pruritus, redness, iritis), headache; keratitis, corneal reactions (eg, epithelial breakdown, thinning, erosion, ulceration/perforation).

How Supplied:

Soln—1.7mL

Last Updated:

11/18/2010

Bromday获准用于减轻白内障手术后的炎症和疼痛

2010年10月16日，ISTA制药公司宣布美国FDA已批准了该公司有关将溴芬酸滴眼液（商品名BROMDAY）0.09%作为每日1次给药用于治疗已接受白内障摘除患者的术后炎症以及减轻其眼痛的补充新药申请。该药预期将在今年年末之前上市。溴芬酸是一种非甾体抗炎药，该药尚未在我国上市。Bromday使用者中最常报告的不良反应是眼部感觉异常、结膜充血和眼部刺激症状(包括灼烧感/针刺感)。