Harrow launches trio of ophthalmic therapeutics in US

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Harrow announced the completion of the transfer to Harrow of the New Drug Applications (NDAs) for nepafenac ophthalmic suspension 0.3% (ILEVRO), nepafenac ophthalmic suspension 0.1% (NEVANAC), and dexamethasone ophthalmic suspension 0.1% (MAXIDEX).

According to the company, these 3 FDA-approved ophthalmic medicines, which are now commercially available under the Harrow umbrella, were among the 5 products that Harrow purchased from Novartis in January of 2023 and for which Harrow has been receiving net profits from unit sales during the NDA transfer process.

The company noted Harrow expects to complete the transfer of the NDAs for the two remaining products, moxifloxacin hydrochloride ophthalmic solution 0.5% (VIGAMOX) and triamcinolone acetonide injectable suspension 40 mg/ml (TRIESENCE), 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,” Mark L. Baum, CEO of Harrow, said in a news release. “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.

Baum added that the company’s research indicates a 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,” he said.

Product orders for or nepafenac ophthalmic suspension 0.3%, nepafenac ophthalmic suspension 0.1%, and dexamethasone ophthalmic suspension 0.1% 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.

Nepafenac ophthalmic suspension 0.3% is a nonsteroidal, anti-inflammatory eye drop indicated for pain and inflammation associated with cataract surgery.

Nepafenac ophthalmic suspension 0.3% is indicated for the treatment of pain and inflammation associated with cataract surgery. It also is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other nonsteroidal anti-inflammatory drugs.

Moreover, nepafenac ophthalmic suspension 0.3% should not be administered to patients for use while wearing contact lenses.

In January, Harrow announced the closing of its acquisition of the exclusive U.S. commercial rights to the five branded ophthalmic products.

According to the news release at the time, Harrow said it expects these products to be immediately financially accretive and reaffirms 2023 guidance of $135 million to $143 million in net revenues and $44 million to $50 million in adjusted EBITDA.

When the agreement was announced in December, Baum pointed out that the deal places the company among the leaders in the U.S. ophthalmic pharmaceuticals market.

“Following the satisfaction of the relevant closing conditions, these products will be immediately accretive to our revenues and excellently complement our current portfolio of ophthalmic prescription products,” he said earlier this year. “We know these products very well and have long appreciated and admired them for the value they have delivered to thousands of U.S. eyecare professionals and many millions of their patients.”