03.30.20

Eyevance Pharmaceuticals Launches Zerviate in the United States

Source: Eyevance Pharmaceuticals

Eyevance Pharmaceuticals has announced the United States launch of Zerviate (cetirizine ophthalmic solution) 0.24% for the treatment of ocular itching associated with allergic conjunctivitis. Zerviate is formulated with Hydrella, the vehicle that contains glycerin and hydroxypropyl methylcellulose (HPMC), two common ingredients found in tear lubricants; therefore, delivering the cetirizine molecule to the eye with optimal ocular comfort, according to a company news release.

The active ingredient in Zerviate 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 vasodilation2-3 and has a strong safety and efficacy profile4 with world-wide exposure to millions of patients over 20 years.

In clinical trials, Zerviate 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 was effective in relieving ocular itching for 8 hours in moderate and severe allergic conjunctivitis patients.5  Zerviate 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 provides ~100-fold lower systemic exposure than cetirizine tablets8, potentially lowering incidence rates for antihistamine-related systemic side effects (e.g., somnolence, fatigue and dry mouth).

“Zerviate’s unique formulation and impressive clinical profile makes it an attractive treatment option for patients who present with allergic conjunctivitis,” Michael Raizman, MD, Associate Professor of Ophthalmology at Tufts University School of Medicine, and private practice at Ophthalmic Consultants of Boston, said in a company news release. “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 for patients with itchy, allergic eyes.”

As Eyevance navigates the current state-of-affairs, its dedicated national sales force will launch Zerviate 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 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, as the company expects a robust, severe allergy season. Eyevance wants to ensure all doctors are informed and equipped to confidently prescribe Zerviate for the treatment of ocular itching associated with allergic conjunctivitis, whether in-office or remote, according to a news release.

Zerviate 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.

“Allergists have been waiting for a new prescription treatment for itch associated with allergic conjunctivitis,” Leonard Bielory, MD, 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, said in the news release. “Zerviate 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.”

“Allergic conjunctivitis is one of the most common conditions that therapeutic optometrists treat on a daily basis, year-round,” said Josh Davidson, OD, FAAO, Director of Dry Eye Center of Excellence, Williamson Eye Center, Baton Rouge, Louisiana. “The introduction of Zerviate provides optometrists a very well-known antihistamine, in cetirizine, to prescribe to their patients. I look forward to having topical Zerviate as part of my armamentarium.”

“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’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.”

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 Allergy Clin Immunol. 1989 May;83(5):905-12.
  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 C0010.
  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 cetirizine ophthalmic solution 0.24% for the treatment of allergic conjunctivitis in adult and pediatric subjects Clin Ophthalmol. 2019:13 403–413.

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