Harrow Completes Transfer of NDAs and Launches FLAREX, NATACYN, TOBRADEX ST, VERKAZIA, and ZERVIATE in the U.S.

Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced the completion of the transfer to Harrow of the New Drug Applications (NDAs) for the following products:

• FLAREX (fluorometholone acetate ophthalmic suspension) 0.1%, a corticosteroid indicated for use in the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.

• NATACYN (natamycin ophthalmic suspension) 5%, a sterile antifungal for treating fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms, including Fusarium solani keratitis.

• TOBRADEX ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05%, an antibiotic and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

• VERKAZIA (cyclosporine ophthalmic emulsion) 0.1%, a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults and holds orphan-drug exclusivity.

• ZERVIATE (cetirizine ophthalmic solution) 0.24%, a histamine-1 (H1) receptor antagonist indicated for treating ocular itching associated with allergic conjunctivitis.

Harrow announced its acquisition of the U.S. commercial rights of these products in July of 2023. To date, Harrow has been receiving profit transfers on these products; however, with the transfer of the NDAs completed, Harrow has launched these products in the U.S. under the Harrow name.

Please see select Important Safety Information for these products and links to the Full Prescribing Information at the end of this release.

In commenting on the announcement, Mark L. Baum, Chief Executive Officer of Harrow, said, “With the completion of the NDA transfer process for the branded ophthalmic portfolio that we recently acquired, our marketing and sales teams are hard at work implementing commercial strategies aimed at increasing brand awareness and sales for these products. These products and others we acquired this year support a growing awareness among U.S. eyecare professionals that Harrow is exclusively focused on and committed to serving U.S. eyecare professionals with a full range of high-quality, accessible, and affordable products they need to care for their patients.”