Harrow a leading U.S. eyecare pharmaceutical company, announced the completion of the transfer to Harrow of the New Drug Applications (NDAs) for ILEVRO® (nepafenac ophthalmic suspension) 0.3%, NEVANAC® (nepafenac ophthalmic suspension) 0.1%, and MAXIDEX® (dexamethasone ophthalmic suspension) 0.1%. These three FDA-approved ophthalmic medicines, which are now commercially available under the Harrow umbrella, were among the five products that Harrow purchased in January of 2023 and for which Harrow has been receiving net profits from unit sales during the NDA transfer process. Harrow expects to complete the transfer of the NDAs for the two remaining products, VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5% and TRIESENCE® 40 mg/ml, by year-end.
“We are delighted to have completed the NDA transfer process for ILEVRO, NEVANAC, and MAXIDEX earlier than our originally estimated six-month period,” said Mark L. Baum, Chief Executive Officer of Harrow. “We can now implement our market access, marketing, inventory management, and national sales detailing strategies for each of these three products, and we expect to extend those efforts when the NDAs for the remaining two products, VIGAMOX and TRIESENCE, are transferred later this year.
“Our market research has shown that the market need for all five of these products continues to increase with U.S. demographic growth and that there are few, if any, new competitive threats, particularly in the NSAID market. These products are used during procedures and within markets in which Harrow already has a strong foothold, and we look forward to making these well-known and valuable ophthalmic medicines available to the eyecare professionals that we serve nationwide as we continue to execute our branded ophthalmic pharmaceuticals market strategy.”
Product orders for ILEVRO, NEVANAC, and MAXIDEX can be made directly through Harrow’s dedicated customer service ordering partner, Cardinal’s Cordlogistics, which includes a wholesaler distribution system encompassing McKesson and AmerisourceBergen.
About Harrow
Harrow is a leading U.S. eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic prescription therapies that are accessible and affordable. Harrow owns U.S. commercial rights to ten FDA-approved ophthalmic pharmaceutical products. Harrow also owns and operates ImprimisRx, the leading U.S. ophthalmic‑focused pharmaceutical compounding business, which also serves as a mail-order pharmacy licensed to ship prescription medications in all 50 states. Harrow has non-controlling equity positions in Surface Ophthalmics, Inc. and Melt Pharmaceuticals, Inc., companies that began as subsidiaries of Harrow. Harrow also owns royalty rights in four late-stage drug candidates being developed by Surface and Melt.