AzaSite[R] Production Increased in Response to Erythromycin Ophthalmic Ointment Shortage.ALAMEDA, Calif. -- InSite Vision Incorporated (OTCBB OTCBB
See OTC Bulletin Board (OTCBB). : INSV INSV Impatiens Necrotic Spot Virus ) today announced that Inspire Pharmaceuticals, its commercial partner for AzaSite[R] (azithromycin ophthalmic solution ophthalmic solution
A sterile solution that is free from foreign particles and is compounded and dispensed for eyedrops. ) 1% in the U.S and Canada, has committed to increasing production of AzaSite in response to the manufacturing supply shortage of erythromycin erythromycin (ĭrĭth'rōmī`sĭn), any of several related antibiotic drugs produced by bacteria of the genus Streptomyces (see antibiotic). ophthalmic ointment (0.5%).
Erythromycin ophthalmic ointment is approved for prophylaxis of ophthalmia neonatorum ophthalmia neonatorum: see conjunctivitis. , a form of bacterial conjunctivitis conjunctivitis (kənjəngtəvī`təs), inflammation or infection of the mucosal membrane that covers the eyeball and lines the eyelid, usually acute, caused by a virus or, less often, by a bacillus, an allergic reaction, or an that may be contracted by newborns during delivery. It is the only product approved for this indication commercially available in the United States. Recently, the U.S. Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) placed erythromycin ophthalmic ointment on the FDA's Drug Shortage list. The Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. (CDC See Control Data, century date change and Back Orifice.
CDC - Control Data Corporation ), the U.S. Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979
Health and Human Services, HHS , the American Academy of Ophthalmology The American Academy of Ophthalmology (AAO) is a medical association of ophthalmologists–medical doctors (MDs) specializing in eye care and surgery).
The group is based in San Francisco, California. and the FDA all recommend that existing supplies of erythromycin ophthalmic ointment be reserved for the treatment of neonatal prophylaxis use.
These organizations are encouraging healthcare professionals to use alternative drugs, including AzaSite, for the treatment of superficial ocular infections involving the conjunctiva and/or cornea cornea: see eye. caused by organisms susceptible to erythromycin, as well as for treatment of post-surgical and posttraumatic posttraumatic /posttrau·mat·ic/ (post?traw-mat´ik) occurring as a result of or after injury.
Following or resulting from injury or trauma. events. In addition, the CDC has recommended AzaSite as an acceptable substitute for neonatal prophylaxis use where erythromycin ophthalmic ointment is not available. AzaSite has not been approved by the FDA for the treatment of prophylaxis of ophthalmia neonatorum and no clinical trials have been conducted using AzaSite in this population. This recommendation was based on available AzaSite data on pharmacology and gonococcal Gonococcal
The bacteria Neisseria gonorrheae that causes gonorrhea, a sexually transmitted infection of the genitals and urinary tract. The gonococcal organism may occasionally affect the eye, causing blindness if not treated.
Mentioned in: Conjunctivitis microbiologic sensitivity. CDC guidance on the erythromycin ophthalmic ointment shortage may be viewed online at: http://www.cdc.gov/std/treatment/2006/erythromycinOintmentShortage.htm
Approved by the FDA in 2007 for the treatment of bacterial conjunctivitis, AzaSite requires the fewest doses per course of treatment of available ocular antibiotic products in the U.S. AzaSite is formulated with InSite Vision's patented DuraSite[R] technology to enhance the retention time of the therapeutic agents on the surface of the eye leading to increased ocular tissue concentrations. InSite Vision and Inspire Pharmaceuticals entered into a licensing agreement for the commercialization of AzaSite in February 2007.
AzaSite[R] (azithromycin ophthalmic solution) 1% is indicated for the treatment of bacterial conjunctivitis caused by the following organisms: CDC coryneform coryneform /co·ry·ne·form/ (-form) denoting or resembling organisms of the family Corynebacteriaceae.
denoting or resembling organisms of the family Corynebacteriaceae. See also diphtheroid. group G, Staphylococcus aureus Staphylococcus au·re·us
A bacterium that causes furunculosis, pyemia, osteomyelitis, suppuration of wounds, and food poisoning.
Staphylococcus aureus Staphylococcus pyogenes , Streptococcus mitis group, Streptococcus pneumoniae Streptococcus pneu·mo·ni·ae
Streptococcus pneumoniae Microbiology A pathogenic streptococcus with 90 serotypes associated with pneumonia, bacteremia, meningitis Transmission Person to person Incidence , and Haemophilus influenzae.
Important Safety Information: In clinical trials, the most common ocular adverse event was eye irritation, which occurred in 1% to 2% of patients. The safety and effectiveness of AzaSite in pediatric patients below 1 year of age have not been established. The efficacy of AzaSite in treating bacterial conjunctivitis in pediatric patients one year or older has been demonstrated in controlled clinical trials. Please see full Prescribing Information for AzaSite at www.azasite.com.
About InSite Vision
InSite Vision is committed to advancing new and superior ophthalmologic products for unmet eye care needs. InSite Vision is recognized for the discovery and development of novel ocular pharmaceutical products based on its DuraSite[R] bioadhesive polymer core technology, an innovative platform that extends the duration of drug delivery on the eye's surface, thereby reducing frequency of treatment and improving the efficacy of topically delivered drugs. The DuraSite platform is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite[R] (azithromycin ophthalmic solution) 1% and Besivance[TM] (besifloxacin ophthalmic suspension) 0.6%. AzaSite is approved in the United States and Canada and currently marketed by InSite Vision's partner, Inspire Pharmaceuticals in the United States. InSite Vision has formed multiple strategic licensing and distribution agreements with qualified partners to market AzaSite in select countries in Asia and South America upon regulatory approval in those regions. Besivance was approved by the U.S. Food and Drug Administration in the second quarter 2009 and is being marketed by Bausch & Lomb and Pfizer Inc.
InSite Vision's ophthalmic product development pipeline also includes ISV-502 and additional product candidates leveraging the company's core technologies. For further information on InSite Vision, please visit www.insitevision.com.
Forward Looking Statements
This news release contains certain statements of a forward looking nature relating to future events, including , InSite's plans to advance its ophthalmologic products, the implication that AsaSite will be commercialize in various territories outside the U.S. and Canada upon regulatory approval in those territories, and InSite's corporate goals. Such statements entail a number of risks and uncertainties, including but not limited to: the results of any future clinical trials InSite may initiate; InSite's reliance on third parties for the commercialization of its products; the ability of InSite to enter into corporate collaborations for its product candidates; InSite's ability to expand its product platform to include additional indications; InSite's ability to compete effectively, either alone or through its partners, with other companies offering competing products or treatments; InSite's ability to maintain and develop additional collaborations and commercial agreements with corporate partners, including those with respect to AzaSite; its ability to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others; and determinations by the FDA. Reference is made to the discussion of these and other risk factors detailed in InSite Vision's filings with the Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly reports on Form 10-Q, under the caption "Risk Factors" and elsewhere in such reports. Any forward looking statements or projections are based on the limited information currently available to InSite Vision, which is subject to change. Although any such forward looking statements or projections and the factors influencing them will likely change, InSite Vision undertakes no obligation to update the information. Such information speaks only as of the date of its release. Actual events or results could differ materially and one should not assume that the information provided in this release is still valid at any later date.