Nearly 8 months after acquiring the U.S. commercial rights to VIGAMOX (moxifloxacin hydrochloride ophthalmic solution) 0.5%, Harrow has officially completed the transfer process of its new drug application (NDA) and made it available in the United States.
Refresh me on this acquisition.
Back in January 2023, Harrow made a deal with Novartis to acquire five of the company’s ophthalmic products (including Vigamox)—making it the second deal between the two companies in less than a year.
Aside from Vigamox, the products included:
- Ilevro (nepafenac ophthalmic suspension) 0.3%
- Nevanac (nepafenac ophthalmic suspension) 0.1%
- Maxidex (dexamethasone ophthalmic suspension) 0.1%
- Triesence (triamcinolone acetonide injectable suspension) 40 mg/ml
What should I know about these products?
Vigamox’s NDA transfer process marks the fourth FDA-approved product from this acquisition; Harrow launched Ilevro, Nevanac, and Maxidex in May 2023.
Gotcha. Now tell me about Vigamox.
Vigamox is a topical fluoroquinolone antibiotic eye drop indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of organisms such as Corynebacterium species, Micrococcus luteus, and Staphylococcus aureus, to name a few.
See here for the complete list.
What’s the recommended dosage?
Per the prescription drug label, one drop of 0.5% moxifloxacin is to be administered in the affected eye three times a day for seven days.
Any warnings or precautions for its use?
Per the eye drop’s prescribing information, patients using the product should be aware of:
- Hypersensitivity reactions (hypersensitivity and anaphylaxis)
- Prolonged used (could result in overgrowth of non-susceptible organisms like fungi)
- Avoiding contact lens wear
How about adverse reactions?
According to the company, the most frequently reported ocular adverse events (AEs) occurred in 1% to 6% of patients, including:
- Conjunctivitis
- Decreased visual acuity
- Dry eye
- Keratitis
- Ocular discomfort
- Ocular hyperemia
- Ocular pain
- Ocular pruritus
- Subconjunctival hemorrhage
- Tearing
Noted. So where can this be purchased?
Vigamox product orders are available via Cardinal’s CORD Logistics, Harrow’s partner for customer service orders, including a wholesaler distribution system with McKesson and AmerisourceBergen.
Harrow’s been pretty busy lately …
Indeed! In July 2023, the company announced the following:
- Acquisition of North American commercial rights to eight ophthalmic brands from Santen Pharmaceuticals
- Purchase of North American commercial rights to VEVYE (cyclosporine ophthalmic solution) 0.1% (from Novaliq)
And in May 2023, the company announced the launch of Iheezo (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia.