Harrow, Inc. (note the name change) announced it has officially completed the subsequent new drug application (NDA) transfer and launch of five ophthalmic products in the United States.
That’s a lot of products … what’s the background on these?
Back in July 2023, Harrow announced it had acquired the U.S. and Canadian commercial rights for specific branded ophthalmic products from Santen Pharmaceutical Co., Ltd.
See here for our coverage on that deal, which also included Canadian products.
Name the five products.
I’ll give you one better; I’ll even include their indications:
- FLAREX (fluorometholone acetate ophthalmic suspension) 0.1%
- 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%
- Indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including Fusarium solani keratitis.
- Is currently the only FDA-approved topical ophthalmic antifungal medication
- TOBRADEX ST (tobramycin/dexamethasone ophthalmic suspension) 0.3%/0.05%
- Indicated 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%
- Indicated for the treatment of vernal keratoconjunctivitis in children and adults
- Patented and “orphan-designated product” for vernal keratoconjunctivitis
- ZERVIATE (cetirizine ophthalmic solution) 0.24%
- Indicated for treatment of ocular itching associated with allergic conjunctivitis.
- For use as a protectant to prevent further irritation or to relieve dryness of the eye along with temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.
Click here for safety information, prescribing info links, contraindications for these products.
Talk money to me.
Harrow previously reported that financing for purchasing these products was provided via an expansion of its credit facility (with funds managed by Oaktree Capital Management).
The transaction was also expected to reduce Harrow’s combined leverage ratio of adjusted EBITDA (earnings before interest, taxes, depreciation, and amortization)—which is a measure of the company’s ability to generate cash flow—to debt.
And to date, the company has been receiving profit transfers for the five products.
Where can I order these products?
Per Harrow, product orders can be made directly through Cardinal’s Cordlogistics (3PL Distribution Services)— its customer service ordering partner—which includes a wholesaler distribution system encompassing McKesson and AmerisourceBergen.
Now the bigger picture.
This major news is just the latest development in Harrow’s continuing efforts to expand its ophthalmic portfolio and become a leader in the U.S. ophthalmic pharmaceutical industry.
See here for a look at its recent acquisitions and launches.