Inspire

 
 
Products

AZASITE®

AZASITE (azithromycin ophthalmic solution) 1% delivers high and sustained concentrations in ocular tissue,1,2 while delivering broad spectrum coverage against the most common ocular pathogens3. Additionally, the active ingredient in AZASITE is azithromycin, which has anti-inflammatory activity.*,4,5,6

Market Opportunity

The current single-entity ocular antibiotic market was approximately $411 million in annual sales in the United States based on data compiled by IMS data for the 12 months ended December 31, 2008.

AZASITE® (azithromycin ophthalmic solution) 1% is indicated for the treatment of bacterial conjunctivitis caused by the following organisms: CDC coryneform group G,** Staphylococcus aureus, Streptococcus mitis group, Streptococcus pneumoniae, and Haemophilus influenzae.

Important Safety Information: AZASITE should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye or otherwise administered systemically. In clinical trials, the most common ocular adverse event was eye irritation, which occurred in 1% to 2% of patients.

Please see full Prescribing Information for AZASITE.

Inspire licensed AZASITE from InSite Vision Incorporated. AZASITE is a registered trademark owned by InSite. ELESTAT is co-promoted under agreement with Allergan, Inc. ELESTAT is a registered trademark owned by Allergan.

* The anti-inflammatory activity of topically administered AZASITE has not been clinically established.

** Efficacy for this organism was studied in fewer than 10 infections.

1 Torkildsen G, O'Brien TP. Clinical Therapeutics, 2008; 30 (11):1-10.

2 Data on file. Inspire Pharmaceuticals, Inc., Study Report 041-103.

3 Data on file, Inspire Pharmaceuticals, Inc., NDA Clinical Summary.

4 Jacot JL, Jacot TA, Sheppard JD Jr, Lattanzio FA Jr, Williams PB, Brubaker K.
Evaluation of MMP 2/9 modulation by azithromycin and DURASITE® on human corneal epithelial cells and bovine corneal endothelial cells in vitro. Poster presented at: 2008 Association for Research in Vision and Ophthalmology Annual Meeting; April 27-May 1, 2008; Fort Lauderdale, FL.

5 Ianaro A, Ialenti A, Maffia P, et al. Anti-inflammatory activity of macrolide antibiotics. J Pharmacol Exp Ther. 2000;292(1):156-163.

6 Shinkai M, Rubin BK. Macrolides and airway inflammation in children. Paediatr Respir Rev. 2005;6(3):227-235.




ELESTAT®

ELESTAT (epinastine HCl ophthalmic solution) 0.05% provides fast-acting, long-lasting relief of ocular itching and is soothing to the eyes. ELESTAT is a mast cell stabilizer, a potent antihistamine and the only product with labeling that cites activity at both the H1 and H2 receptors.

Market Opportunity

Allergies affect more than 40 million people in the U.S. annually, according to the American Academy of Allergy, Asthma & Immunology. The annual U.S. market for prescription ocular allergy products was approximately $505 million, based on IMS data for the 12 months ended December 31, 2008.

ELESTAT® (epinastine HCl ophthalmic solution) 0.05% is indicated for the prevention of ocular itching associated with allergic conjunctivitis.

Important Safety Information: ELESTAT ophthalmic solution is contraindicated in those patients who have shown hypersensitivity to epinastine or to any of the other ingredients.

Patients should be advised not to wear a contact lens if their eye is red. ELESTAT ophthalmic solution should not be used to treat contact lens related irritation. The preservative in ELESTAT, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of ELESTAT ophthalmic solution and may be reinserted after 10 minutes following its administration. The most frequently reported ocular adverse events occurring in approximately 1% to 10% of patients were burning sensation in the eye, folliculosis, hyperemia, and pruritus.

The most frequently reported nonocular adverse events were infection (cold symptoms and upper respiratory infections), seen in approximately 10% of patients, and headache, rhinitis, sinusitis, increased cough, and pharyngitis seen in approximately 1% to 3% of patients. Some of these events were similar to the underlying disease being studied.

Please see full Prescribing Information for ELESTAT.