Harrow Health announced the completion of the transfer to Harrow of the new drug applications (NDAs) of recently acquired, FDA-approved ophthalmic medicines, Iopidine 1%, Maxitrol 3.5mg/10,000 units/0.1%, and Moxeza 0.5%.
Harrow also announced that Iopidine 1% and Maxitrol are now commercially available. Harrow intends to commercialize Moxeza 0.5% at a later date. Harrow purchased these medicines in December 2021 and has been receiving net profits from unit sales during the NDA transfer process.
“We are pleased to have completed the transfer of the NDAs for these workhorse products, allowing us to market and sell these well-known products under the Harrow umbrella,” said Mark L. Baum, CEO of Harrow Health. “We believe there is strong interest from physicians and their patients, hospitals, and ambulatory surgery centers (ASCs) in these products. The transfer of these NDAs gives Harrow a foundation to begin market access initiatives and lead conversations with commercial payer decision makers as we continue to execute our branded ophthalmic pharmaceuticals strategy.”
Product orders for Iopidine 1% and Maxitrol can be made directly through Harrow’s dedicated customer service ordering partner, Cardinal’s Cordlogistics, which includes a wholesaler distribution system that encompasses McKesson and AmerisourceBergen.
Iopidine 1% Ophthalmic Solution contains apraclonidine hydrochloride, an alpha-adrenergic agonist, in a sterile isotonic solution for topical application to the eye. It is indicated to control or prevent post-surgical elevations in IOP that occur in patients after argon laser trabeculoplasty, argon laser iridotomy, or Nd:YAG posterior capsulotomy.
Maxitrol (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. It is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.
Moxeza (moxifloxacin ophthalmic solution) is a sterile solution for topical ophthalmic use. Moxeza is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerococcus viridans*, Corynebacterium macginleyi*, Enterococcus faecalis*, Micrococcus luteus*, Staphylococcus arlettae*, Staphylococcus aureus, Staphylococcus capitis, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus*, Staphylococcus warneri*, Streptococcus mitis*, Streptococcus pneumoniae, Streptococcus parasanguinis*, Escherichia coli*, Haemophilus influenzae, Klebsiella pneumoniae*, Propionibacterium acnes, Chlamydia trachomatis.*
*Efficacy for this organism was studied in fewer than 10 infections.