Harrow, Inc. engages in the development, production, and sale of innovative medications. It operates through the following segments: Pharmaceutical Compounding and Pharmaceutical Drug Development. The Pharmaceutical Compounding segment focuses on the operations of the ImprimisRx business. The company was founded by Mark L. Baum and Robert J. Kammer in January 2006 and is headquartered in Nashville, TN.
相关临床试验
3
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1998
已完成
2
66.7%
招募中
1
33.3%
暂无批准数据
- China's National Medical Products Administration accepted for review the NCX 470 New Drug Application submitted in August 2026 by licensee Ocumension Therapeutics. - NCX 470 is a nitric oxide-donating bimatoprost eye drop that lowers intraocular pressure through two distinct pathways in open-angle glaucoma or ocular hypertension. - The Chinese review is expected to take 12 to 18 months, with a decision anticipated after the U.S. FDA's 30 April 2027 PDUFA date. - Ocumension has paid Nicox EUR 18 million in license fees, funded 50% of the Denali trial, and will pay tiered royalties of 6% to 12% on sales.
- A sharp rotation out of overvalued AI and semiconductor stocks is driving capital into biotechnology, healthcare, and other previously overlooked sectors. - The Nasdaq 100 fell 3.2% while semiconductors dropped around 7%, yet market breadth remained positive as investors sought safer, less extended positions. - Biotech names including Definium Therapeutics, Xeris Biopharma, and Cullinan Therapeutics are benefiting from rotational momentum ahead of key clinical and earnings catalysts. - Definium Therapeutics (DFTX) surged 50% in a single day and is holding gains as the market anticipates its upcoming Phase 3 data readout for Generalized Anxiety Disorder.
- Harrow has reintroduced VERKAZIA (cyclosporine ophthalmic emulsion) 0.1% to the U.S. market, the first and only FDA-approved topical immunomodulator for pediatric VKC. - VKC is a chronic, potentially sight-threatening allergic eye disease primarily affecting children, with approximately 61% of patients inadequately controlled on antihistamines alone. - VERKAZIA targets underlying inflammatory mechanisms without the risks of glaucoma or cataract formation associated with chronic corticosteroid use. - The re-launch is supported by a comprehensive commercial strategy focused on physician education, patient access, and affordability to ensure dependable supply.
- Harrow announced the acquisition of Melt Pharmaceuticals, which developed MELT-300, a sublingual sedation therapy combining midazolam and ketamine for non-opioid procedural sedation. - MELT-300 demonstrated statistical superiority over sublingual midazolam alone (P=0.009) and placebo (P=<0.0001) in the pivotal LOUISE Phase 3 study for successful procedural sedation. - The acquisition positions Harrow to enter the multi-billion-dollar U.S. procedural sedation market with plans for FDA submission in 2027 and potential commercial launch in 2028. - Harrow's existing experience with MKO Melt, used in over 500,000 cataract surgeries by more than 700 ophthalmologists, provides a foundation for MELT-300's market introduction.
- Harrow has entered into a partnership with Samsung Bioepis to gain exclusive US commercial rights to two FDA-approved ophthalmology biosimilars, BYOOVIZ and OPUVIZ, following Biogen's termination of its commercialization agreement. - The biosimilars target the $9 billion retinal disease treatment market, offering 30-40% wholesale acquisition cost reduction compared to reference drugs LUCENTIS and EYLEA. - BYOOVIZ became the first ophthalmology biosimilar approved in the US in September 2021, while OPUVIZ received FDA approval in May 2024 for broader indications including diabetic retinopathy. - The transition is expected to drive Harrow's revenue past $280 million in 2025, with analysts projecting the company could capture 15-20% of the US retinal disease market within three years.
• Nordic Pharma, a subsidiary of Nordic Group B.V., has partnered with Harrow to launch an authorized generic version of Maxitrol ophthalmic suspension for treating bacterial eye infections. • The new generic alternative enters a market where Maxitrol and its generic equivalents generated annual sales of $20.8 million in the U.S. as of January 2025, according to IQVIA data. • This product expansion strengthens Nordic Pharma's generic portfolio and aims to provide patients with a more affordable prescription option for treating ocular bacterial infections.
- Eyenovia has entered into a non-binding letter of intent with Betaliq to create a new publicly-listed eye care company valued at approximately $92 million, with Betaliq shareholders owning 83.7% of the combined entity. - The merger would combine Betaliq's EyeSol® water-free drug delivery technology for glaucoma with Eyenovia's Optejet® device platform, potentially creating a revolutionary approach to topical eye medication administration. - If completed, the combined company would continue marketing Eyenovia's FDA-approved products while developing new treatment options for glaucoma and other ocular diseases through established partnerships.
• Harrow has executed a five-year strategic supply and development agreement with the current contract manufacturing organization for TRIESENCE®, ensuring stable supply of the ocular corticosteroid. • The company has begun developing an enhanced version of TRIESENCE®, with plans to submit a new drug application (NDA) to the FDA by the end of 2027. • TRIESENCE® is FDA-approved for visualization during vitrectomy and treatment of ocular inflammatory conditions unresponsive to topical corticosteroids, addressing a product previously on the FDA's Drug Shortage List.
