Mar 30, 2020   SOURCE: PR NewsWire

Eyevance Pharmaceuticals Launches ZERVIATE(TM) in the United States

FORT WORTH, Texas, March 30, 2020 /PRNewswire/ -- Eyevance Pharmaceuticals, committed to developing and commercializing innovative and impactful ophthalmic products, is pleased to announce the United States launch of ZERVIATE(TM) (cetirizine ophthalmic solution) 0.24% for the treatment of ocular itching associated with allergic conjunctivitis. ZERVIATE(TM) is formulated with Hydrella(TM), the vehicle that contains glycerin and hydroxypropyl methylcellulose (HPMC), two very common ingredients found in tear lubricants; therefore, delivering the cetirizine molecule to the eye with optimal ocular comfort.

IMPORTANT: As Eyevance navigates the current state-of-affairs, its dedicated national sales force will launch ZERVIATE(TM) through their recently deployed remote virtual selling platform, enabling the team to connect live nationwide with ophthalmologist, optometrists, allergists and their respective office staff team members. The sales force will introduce, educate and supply doctors with product information, with an opportunity to order patient samples and provide details on our patient co-pay savings program, which will allow instant, remote access to ZERVIATE(TM) co-pay savings at www.myeyesavings.com. In addition, Eyevance plans to host numerous local, regional and national webinars to allow immediate exposure and education on ZERVIATE(TM), as we expect a robust, severe allergy season. Eyevance wants to ensure all doctors are informed and equipped to confidently prescribe ZERVIATE(TM) for the treatment of ocular itching associated with allergic conjunctivitis, whether in-office or remote.

The active ingredient in ZERVIATE(TM) is cetirizine, an antihistamine that is highly selective in blocking the H1 receptor. Cetirizine, in the approved oral formulation - Zyrtec®, binds competitively to histamine receptors to reduce swelling, itching and vasodilation(2-3 )and has a strong safety and efficacy profile(4) with world-wide exposure to millions of patients over 20 years.

In clinical trials, ZERVIATE(TM) demonstrated rapid onset of action, effectively relieving ocular itching within 3 minutes,(5) as well as more rapid relief of ocular allergic conjunctivitis symptoms than systemic antihistamines.(6-7 )ZERVIATE(TM) was effective in relieving ocular itching for 8 hours in moderate and severe allergic conjunctivitis patients.(5 )ZERVIATE(TM) also showed an excellent safety profile (ages 2 and up) and was reported to be highly comfortable on instillation.(8 )As a topical agent, ZERVIATE(TM) provides ~100-fold lower systemic exposure than cetirizine tablets(8), potentially lowering incidence rates for antihistamine-related systemic side effects (e.g., somnolence, fatigue and dry mouth).

"ZERVIATE's(TM) unique formulation and impressive clinical profile makes it an attractive treatment option for patients who present with allergic conjunctivitis," said Michael Raizman, M.D., Associate Professor of Ophthalmology at Tufts University School of Medicine, and private practice at Ophthalmic Consultants of Boston. "Cetirizine is a well-established treatment for allergic inflammation. Its availability in a topical form facilitates localized, targeted treatment - which can have significant patient benefits over systemic options. The clinical trial data were impressive. I look forward to prescribing ZERVIATE(TM) for patients with itchy, allergic eyes."

ZERVIATE(TM) received FDA new drug approval on May 30, 2017. Two Phase 3 studies demonstrated statistically significant and clinically relevant results over vehicle in the reduction of ocular itch in moderate and severe allergic conjunctivitis subjects, and further safety data was collected and evaluated in three additional trials (assessing pharmacokinetics, dosing frequency, and tolerability). In addition, there were numerous ocular and nasal secondary endpoints that were explored.(5 )

"Allergists have been waiting for a new prescription treatment for itch associated with allergic conjunctivitis," stated Leonard Bielory, M.D., Professor of Medicine, Allergy, Immunology and Ophthalmology at Hackensack Meridian School of Medicine at Seton Hall University and private Practice at University Asthma and Allergy Associates. "ZERVIATE(TM) is a welcomed addition, as cetirizine is widely known and recognized for its efficacy and safety profile. Having an ocular formulation of cetirizine is a great treatment option for allergists nationwide."

One of the most unique aspects of treating allergic conjunctivitis is the broad spectrum of specialists that patients seek out for relief from itchy eyes. ZERVIATE(TM) provides Ophthalmologists, Optometrists and Allergists an effective option to treat allergy sufferers.

"Allergic conjunctivitis is one of the most common conditions that therapeutic optometrists treat on a daily basis, year-round," shared Josh Davidson, O.D., F.A.A.O., Director of Dry Eye Center of Excellence, Williamson Eye Center, Baton Rouge, Louisiana. "The introduction of ZERVIATE(TM) provides optometrists a very well-known antihistamine, in cetirizine, to prescribe to their patients. I look forward to having topical ZERVIATE(TM) as part of my armamentarium."

Since inception in September 2017, Eyevance has acquired or licensed products that treat ocular diseases or conditions that may require an antibiotic, corticosteroid, antihistamine, antibiotic/corticosteroid, tear lubricant, antifungal, or the rare disease/orphan condition of persistent epithelial defects. The widespread ensemble of anterior segment and ocular surface medications assists in driving Eyevance's business strategy. Other commercialized products include:

    --  FLAREX® (fluorometholone acetate ophthalmic suspension) 0.1%
    --  TOBRADEX® ST (tobramycin/dexamethasone ophthalmic suspension)
        0.3%/0.05%
    --  NATACYN® (natamycin ophthalmic suspension) 5%
    --  FRESHKOTE® Preservative-Free (PF) tear lubricant

"Eyevance is building its core business around the commercialization of standout anterior segment and ocular surface products," said Jerry St. Peter, Chief Executive Officer, Director and Co-Founder, Eyevance. "Accordingly, ZERVIATE(TM)'s launch represents a critical milestone as we continue to enhance our product offerings to serve all treatable conditions within our core therapeutic areas. We are proud to offer this unique and effective product to eye care professionals and allergists in the United States and look forward to announcing additional milestones in the future."

Important Information About ZERVIATE(TM)

INDICATION: ZERVIATE(TM) (cetirizine ophthalmic solution) 0.24% is indicated for treatment of ocular itching associated with allergic conjunctivitis.

DOSAGE AND ADMINISTRATION: The recommended dose is one drop in each affected eye twice daily (approximately 8 hours apart).

IMPORTANT SAFETY INFORMATION: The most commonly reported adverse reactions occurred in approximately 1-7% of patients treated with either ZERVIATE(TM) or vehicle. These reactions were ocular hyperemia, instillation site pain, and reduction in visual acuity.

For complete product information about ZERVIATE(TM), including important safety information, please visit https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208694s006lbl.pdf.

For complete product information about TOBRADEX® ST, including important safety information, please visit https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050818lbl.pdf.

For complete product information about FLAREX®, including important safety information, please visit https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019079s030lbl.pdf.

For complete product information about NATACYN®, including important safety information, please visit https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050514s009lbl.pdf.

About Eyevance Pharmaceuticals
Eyevance Pharmaceuticals is a Fort Worth, Texas-based company committed to developing and commercializing innovative and impactful ophthalmic products that enable optimal vision and better quality of life for all patients. Eyevance seeks to establish a portfolio of products that address significant unmet needs, including rare and orphan conditions, while also focusing on products with a legacy of proven safety and efficacy. For more information, visit http://eyevance.com.

Contact

For additional information, please contact:
Allison Howell
Senior Account Director, Pascale
412.228.1678 | allison@pascalecommunications.com

References:

    1. Zyrtec® is a trademark of Johnson & Johnson.
    2. Charlesworth EN, et. al. Effect of cetirizine on mast cell-mediator
       release and cellular traffic during the cutaneous late-phase reaction. J
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    3. Levi-Schaffer F, Eliashar R. (2009). Mast cell stabilizing properties of
       antihistamines. J. Invest. Dermatol. 129, 2549-2551.
    4. Gomes PJ, Raval Y, Schoemmell E, Welch DL. ARVO 2014, Poster number
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    5. Meier EJ, Torkildsen GL, Gomes PJ, Jasek MC Phase III trials examining
       the efficacy of cetirizine ophthalmic solution 0.24% compared to vehicle
       for the treatment of allergic conjunctivitis in the conjunctival allergen
       challenge model Clin Ophthalmol. 2018:12 2617-2628
    6. Spangler, DL, et al. Clin Ther, 2003. 25(8): p. 2245-67.
    7. Abelson, MB and Welch DL. Acta Ophthalmol Scand Suppl, 2000(230): p.
       60-3.
    8. Malhotra RP, Meier EJ, Torkildsen GL, Gomes PJ, Jasek MC Safety of
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SOURCE Eyevance Pharmaceuticals