XiidraTreatment for Dry Eye Disease
Update: Xiidra (lifitegrast) Now FDA Approved - July 11, 2016
U.S. FDA Acknowledges Receipt of Resubmission of Shire’s NDA for Lifitegrast for Dry Eye Disease in Adults
Lexington, Mass. – February 4, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for lifitegrast for the treatment of signs and symptoms of dry eye disease in adults. Shire resubmitted the NDA in response to the complete response letter (CRL) received from the FDA on October 16, 2015 that requested an additional clinical study and more information related to product quality. The FDA determined that the submission is a complete response and has assigned a 6-month review period for the NDA and a Prescription Drug User Fee Act (PDUFA) goal date of July 22, 2016.
“The resubmission is an important milestone for Shire and our commitment to providing a new treatment option for the 29 million adults in the U.S. living with the symptoms of dry eye disease,” said Philip J. Vickers, Ph.D., Head of Research & Development, Shire. “We believe that this resubmission package, which includes our positive OPUS-3 data, as well as information about product quality, will address the requests from the FDA. Ophthalmics is a key focus area for Shire, and we’re pleased to see our lead candidate continue to advance.”
The new drug application for lifitegrast now includes data from five clinical trials, including one Phase 2 study, three Phase 3 safety and efficacy studies (OPUS-1, OPUS-2 and OPUS-3) and one long-term (one year) Phase 3 safety study (SONATA). This is the largest clinical trial program for an investigational-stage compound in dry eye disease with over 2,500 patients.
Shire originally submitted the NDA for lifitegrast to the FDA in February 2015. In April 2015, the FDA granted Priority Review designation to lifitegrast, which accelerated the review target to eight months instead of the standard 12 months.
Lifitegrast binds to the integrin lymphocyte function-associated antigen-1 (LFA-1), a cell surface protein found on leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1). ICAM-1 is over-expressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1 interaction contributes to formation of an immunological synapse resulting in T-cell activation and migration to target tissues. In vitro studies have demonstrated that lifitegrast inhibits T-cell adhesion to ICAM-1 expressing cells and inhibits secretion of key inflammatory cytokines (IFNγ, TNFα, IL-2) as well as inhibiting other proinflammatory cytokines: IL-1α, IL-1β, IL-2, IL-4, IL-5, and IL-13, all of which are known to be associated with dry eye disease.
OPUS-3, a Phase 3 study that evaluated the efficacy and safety of lifitegrast 5% versus placebo, met the primary endpoint of significantly improving patient-reported symptoms of dry eye disease from baseline to day 84 (p=0.0007), and met key secondary endpoints of symptom improvement from baseline to days 14 and 42 (p<0.0001 for both endpoints).
About Dry Eye Disease
Dry eye is a multifactorial disease of the tears and ocular surface. It is diagnosed by an eye care professional based on patient reported symptoms, such as eye dryness, overall eye discomfort, stinging, burning, a gritty feeling or fluctuating blurry vision, as well as signs, which can be measured by an eye care professional to determine the presence of dry eye disease (e.g., Schirmer test, corneal fluorescein staining, conjunctival lissamine green staining, and tear break-up time). Age and gender are recognized as traditional risk factors of dry eye disease while modern risk factors include prolonged screen time, contact lens wear and cataract or refractive surgery. Dry eye is an often chronic ocular disease associated with inflammation that may eventually lead to damage to the surface of the eye. Dry eye may be progressive and is a common complaint to eye care professionals.
Shire’s Commitment to Ophthalmics
In May 2014, Shire established its Ophthalmics Business Unit, solidifying its commitment to growing in this therapeutic area. Shire’s multi-faceted approach to discovery, development, and delivery in both rare diseases and specialty conditions includes our efforts to address unmet needs in eye care.
Shire’s ophthalmics business has been driven by a combination of strategic acquisitions and organic growth. Committed to growing its reputation as a leading biotech company, Shire is focused on continuing to expand its ophthalmics portfolio to include treatment options for rare diseases and those for anterior and posterior segment eye conditions. In just over two years, acquisitions include Foresight Biotherapeutics, SARcode Bioscience, Premacure AB, and BIKAM Pharmaceuticals, which have helped bolster Shire’s early-, mid- and late-stage ophthalmics pipeline. The Company currently has an ophthalmics pipeline of investigational candidates in dry eye disease, infectious conjunctivitis, retinopathy of prematurity, autosomal dominant retinitis pigmentosa, and glaucoma.
THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts, including without limitation statements concerning our proposed business combination with Baxalta Incorporated (“Baxalta”) and the timing and financial and strategic benefits thereof, our 20x20 ambition that targets $20 billion in combined product sales by 2020, as well as other targets for future financial results, capital structure, performance and sustainability of the combined company, the combined company’s future strategy, plans, objectives, expectations and intentions, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:
All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Source: Shire plc
Posted: February 2016
- FDA Approves Xiidra (lifitegrast ophthalmic solution) for Dry Eye Disease - July 12, 2016
- Shire Resubmits New Drug Application for Lifitegrast to U.S. FDA - January 25, 2016
- Shire Receives FDA Complete Response Letter for Lifitegrast NDA and Plans to Respond with OPUS-3 Trial - October 16, 2015
- U.S. FDA Grants Priority Review to Lifitegrast NDA for the Treatment of Dry Eye Disease in Adults - April 9, 2015
- Shire Submits NDA to the FDA for Approval of Lifitegrast For Treatment of Dry Eye Disease in Adults - March 2, 2015
- Shire Plans to Submit a New Drug Application to FDA for Lifitegrast for Dry Eye Disease in Adults - May 16, 2014
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our Newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.