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NASHVILLE, Tenn. - Harrow (NASDAQ:HROW), a prominent eyecare pharmaceutical company in North America, announced today that the Centers for Medicare & Medicaid Services (CMS) has granted transitional pass-through status for its product, TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL. This decision, effective from April 1, 2025, enables separate reimbursement for TRIESENCE in Ambulatory Surgery Center (ASC) and Hospital Outpatient Department (HOPD) settings for a period of three years.
The CMS approval positions TRIESENCE as the sole preservative-free synthetic corticosteroid to be separately reimbursable across all traditional care settings, including eyecare professional offices, ASCs, and HOPDs. Harrow’s Chairman and CEO, Mark L. Baum, expressed gratitude for CMS’s recognition of the drug’s contribution to ophthalmic care. He emphasized that this approval enhances patient access to an FDA-approved treatment option, potentially improving surgical outcomes and patient safety nationwide. According to InvestingPro data, Harrow maintains strong gross margins of 72.5%, suggesting efficient operations and pricing power in its market. For deeper insights into Harrow’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.
TRIESENCE, which is used for visualization during vitrectomy procedures and to treat ocular inflammatory conditions unresponsive to topical corticosteroids, will be reimbursed at the Average Sales Price plus 6% in both ASC and HOPD settings. The CMS had previously approved a permanent J-Code (J3300) for the drug, facilitating billing and ordering processes in eyecare professionals’ offices.
Healthcare providers can order TRIESENCE through major pharmaceutical specialty distributors, and it is listed under two National Drug Codes (NDC). For more information on TRIESENCE, healthcare professionals can visit the dedicated website.
Harrow, Inc. is engaged in the development and commercialization of ophthalmic pharmaceuticals for the North American market, with a focus on making its products accessible and affordable.
This news is based on a press release statement and contains forward-looking statements, which involve risks and uncertainties that could cause actual results to differ materially from those projected. The forward-looking statements reflect management’s current expectations and are not guarantees of future performance. Additional information regarding these risks and uncertainties is available in Harrow’s filings with the Securities and Exchange Commission.
In other recent news, Harrow Inc. reported preliminary financial results for the fourth quarter and full-year 2024, surpassing expectations. The company announced fourth-quarter revenue between $65 million and $67 million, exceeding the anticipated $59 million, and a net income ranging from $5 million to $7 million, contrary to the expected net loss of $200,000. For the full year, Harrow’s revenue was between $198 million and $200 million, with a net loss projected between $17 million and $19 million. H.C. Wainwright maintained a Buy rating for Harrow with a $57 price target, highlighting the company’s rapid growth and successful strategy in acquiring underappreciated ophthalmic products. The firm projected Harrow’s revenue to reach $191.8 million in 2024, reflecting a 47% year-over-year increase.
Additionally, Harrow announced the resignation of board member Marty A. Makary, effective January 19, 2025, and reduced its board size from five to four members. In another development, Dr. Amir H. Shojaei was appointed as the new Chief Scientific Officer, bringing extensive experience in life sciences and ophthalmology. Dr. Shojaei’s appointment is expected to enhance Harrow’s growth and innovation in the ophthalmic pharmaceuticals sector. These developments indicate Harrow’s strategic focus on expanding its leadership and product portfolio.
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