“XIPERE® is the primary and solely remedy obtainable in the USA that makes use of the suprachoroidal area to deal with sufferers who battle with macular edema related to uveitis, which is the main reason behind imaginative and prescient loss in individuals with uveitis2,” stated Joseph C. Papa, chairman and CEO, Bausch Well being. “All through the previous a number of months, we’ve got been coaching eye care professionals everywhere in the nation on find out how to correctly administer XIPERE® utilizing its distinctive suprachoroidal injection methodology, which allows focused supply and compartmentalization of the treatment. We’re happy that XIPERE® is now broadly obtainable as a brand new and distinctive remedy choice for the 300,000 People who are suffering from this severe situation.3“
Macular edema is the buildup of fluid within the macula, which causes retinal swelling and distorted imaginative and prescient, and if left untreated, could result in everlasting imaginative and prescient loss.4 XIPERE® is authorized for the remedy of macular edema related to uveitis by way of suprachoroidal administration utilizing the proprietary SCS Microinjector® developed by Clearside.
“The commercialization of XIPERE® is an thrilling step ahead for the remedy of macular edema related to uveitis, and likewise for rising training and recognition of the suprachroidal area as a extremely efficient administration route for back-of-the-eye therapies,” stated George Lasezkay, Pharm.D., J.D., president and CEO, Clearside. “As the primary business product developed by Clearside and the primary remedy authorized for macular edema related to uveitis, XIPERE® represents our dedication to delivering a lot wanted remedies for these residing with severe retinal illnesses.”
Suprachoroidal administration is an revolutionary method for delivering ocular therapies which will facilitate extra focused supply of therapeutic brokers to the retina and choroid. The suprachoroidal area is positioned between the sclera and the choroid, which expands upon injection, permitting supply of XIPERE® to the posterior buildings of the attention.5
“Suprachoroidal administration, which supplies distinctive entry and excessive bioavailability to the posterior section of the attention, has been properly tolerated by sufferers,” stated Steven Yeh, M.D., professor of Ophthalmology and director of Retinal Illness and Uveitis, Stanley M. Truhlsen Eye Institute, College of Nebraska Medical Middle, and principal investigator for the XIPERE® Section 3 pivotal examine. “This administration method is in contrast to conventional intraocular administration, and due to this fact, coaching for find out how to correctly inject sufferers with this new medication is necessary. I encourage eye care professionals to benefit from the trainings being supplied by Bausch + Lomb.”
Necessary Security Details about XIPERE®
XIPERE® (triamcinolone acetonide injectable suspension) is a corticosteroid used to deal with macular edema related to an eye fixed illness referred to as uveitis.
IMPORTANT SAFETY INFORMATION
To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb at 1-800-321-4576 or FDA at 1-800-FDA-1088 or go to www.fda.gov/medwatch.
Please click here for full Prescribing Data
About Clearside Biomedical
Clearside Biomedical, Inc. is a biopharmaceutical firm revolutionizing the supply of therapies to the again of the attention by means of the suprachoroidal area (SCS®). Clearside’s SCS injection platform, using the Firm’s proprietary SCS Microinjector®, allows an in-office, repeatable, non-surgical process for the focused and compartmentalized supply of all kinds of therapies to the macula, retina or choroid to probably protect and enhance imaginative and prescient in sufferers with sight-threatening eye illnesses. Clearside is creating its personal pipeline of small molecule product candidates for administration by way of its SCS Microinjector and strategically companions its SCS injection platform with firms using different ophthalmic therapeutic improvements. For extra data, please go to www.clearsidebio.com.
About Bausch + Lomb
Bausch + Lomb, a number one international eye well being enterprise of Bausch Well being Firms, Inc., is devoted to defending and enhancing the present of sight for tens of millions of individuals around the globe – from the second of beginning by means of each section of life. Its complete portfolio of greater than 400 merchandise contains contact lenses, lens care merchandise, eye care merchandise, ophthalmic prescription drugs, over-the-counter merchandise and ophthalmic surgical gadgets and devices. Based in 1853, Bausch + Lomb has a big international analysis and growth, manufacturing and business footprint with greater than 12,000 staff and a presence in almost 100 nations. Bausch + Lomb is headquartered in Vaughan, Ontario with company workplaces in Bridgewater, New Jersey. For extra data, go to www.bausch.com and join with us on Twitter, LinkedIn, Facebook and Instagram.
About Bausch Well being
Bausch Well being Firms Inc. (NYSE/TSX: BHC) is a worldwide firm whose mission is to enhance individuals’s lives with our well being care merchandise. We develop, manufacture and market a spread of pharmaceutical, medical gadget and over-the-counter merchandise, primarily within the therapeutic areas of eye well being, gastroenterology and dermatology. We’re delivering on our commitments as we construct an revolutionary firm devoted to advancing international well being. For extra data, go to www.bauschhealth.com and join with us on Twitter and LinkedIn.
Clearside Biomedical Ahead-Trying Statements
Any statements contained on this press launch that don’t describe historic information could represent forward-looking statements as that time period is outlined within the Personal Securities Litigation Reform Act of 1995. These statements could also be recognized by phrases akin to “imagine”, “count on”, “could”, “plan”, “potential”, “will”, and related expressions, and are based mostly on Clearside’s present beliefs and expectations. These forward-looking statements embody statements concerning the business launch of XIPERE. These statements contain dangers and uncertainties that would trigger precise outcomes to vary materially from these mirrored in such statements. Dangers and uncertainties which will trigger precise outcomes to vary materially embody uncertainties inherent within the conduct of medical trials, Clearside’s reliance on third events over which it could not all the time have full management, uncertainties concerning the COVID-19 pandemic and different dangers and uncertainties which might be described in Clearside’s Annual Report on Kind 10-Ok for the 12 months ended December 31, 2021, filed with the SEC on March 11, 2022, and Clearside’s different Periodic Experiences filed with the SEC. Any forward-looking statements communicate solely as of the date of this press launch and are based mostly on data obtainable to Clearside as of the date of this launch, and Clearside assumes no obligation to, and doesn’t intend to, replace any forward-looking statements, whether or not because of new data, future occasions or in any other case.
Bausch Well being Ahead-looking Statements
This information launch could comprise forward-looking statements, which can typically be recognized by means of the phrases “anticipates,” “hopes,” “expects,” “intends,” “plans,” “ought to,” “may,” “would,” “could,” “believes,” “estimates,” “potential,” “goal,” or “proceed” and variations or related expressions. These statements are based mostly upon the present expectations and beliefs of administration and are topic to sure dangers and uncertainties that would trigger precise outcomes to vary materially from these described within the forward-looking statements. These dangers and uncertainties embody, however are usually not restricted to, the dangers and uncertainties mentioned in Bausch Well being’s most up-to-date annual report on Kind 10-Ok and detailed occasionally in Bausch Well being’s different filings with the U.S. Securities and Alternate Fee and the Canadian Securities Directors, which elements are included herein by reference. Additionally they embody, however are usually not restricted to, dangers and uncertainties attributable to or referring to the evolving COVID-19 pandemic, and the concern of that pandemic and its potential results, the severity, length and future impression of that are extremely unsure and can’t be predicted, and which can have a cloth hostile impression on Bausch Well being, together with however not restricted to its challenge growth timelines, launches and prices (which can improve). Readers are cautioned to not place undue reliance on any of those forward-looking statements. These forward-looking statements communicate solely as of the date hereof. Bausch Well being undertakes no obligation to replace any of those forward-looking statements to mirror occasions or circumstances after the date of this information launch or to mirror precise outcomes, except required by regulation.
- XIPERE® [prescribing information]. Alpharetta, GA: Clearside Biomedical, Inc.; 2021.
- Massa, H., Pipis, S. Y., Adewoyin, T., Vergados, A., Patra, S., & Panos, G. D. (2019). Macular edema related to non-infectious uveitis: pathophysiology, etiology, prevalence, impression and administration challenges. Medical Ophthalmology (Auckland, N.Z.), 13, 1761–1777. https://doi.org/10.2147/OPTH.S180580
- Thorne JE, Suhler E, Skup M, et al. Prevalence of Noninfectious Uveitis in the USA: A Claims-Primarily based Evaluation. JAMA Ophthalmol. 2016;134:1237-1245.
- American Academy of Ophthalmology. Retrieved from https://www.aao.org/eye-health/diseases/what-is-macular-edema . Accessed August 20, 2021.
- Chiang B, Jung JH, Prausnitz MR. The suprachoroidal area as a route of administration to the posterior section of the attention. Adv Drug Deliv Rev. 2018;126:58-66.
XIPERE®, SCS® and SCS Microinjector® are logos of Clearside Biomedical, Inc. used beneath license. Every other product/model names and/or logos are logos of the respective house owners.
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SOURCE Bausch Well being Firms Inc.; Clearside Biomedical, Inc.