Harrow Health Inc Stock Price, News & Analysis

Harrow (Nasdaq: HROW) has successfully manufactured the first of three commercial-scale process performance qualification (PPQ) batches of TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL, an FDA-approved corticosteroid for ocular surgeries and inflammatory conditions. The remaining two PPQ batches are scheduled, and if all batches meet specifications, TRIESENCE will relaunch in 2024. TRIESENCE has been on the FDA Drug Shortage List for over five years, with no inventory available in the U.S. for over two years. Harrow is committed to quickly building commercial inventories, though initial supplies may not meet market demand. Pre-commercial activities and discussions with strategic accounts for pre-orders are underway.

Melt Pharmaceuticals has dosed the first patient in its Phase 3 clinical trial for MELT-300, a non-IV, non-opioid sedation tablet, targeting procedural sedation during cataract surgery. MELT-300 combines midazolam and ketamine in a sublingual, fast-dissolving format. The trial is a randomized, double-blind study involving 528 patients across 14 clinical sites, comparing MELT-300 to sublingual midazolam and a placebo. Previous Phase 2 trials showed MELT-300's superior efficacy. Topline results are expected in Q4 2024. CEO Dr. Larry Dillaha highlighted the innovation in sedation and potential expansion to over 100 million annual procedures in various medical fields.

Harrow (Nasdaq: HROW) announced results from its ESSENCE-2 open-label extension (OLE) clinical study for VEVYE® (cyclosporine ophthalmic solution) 0.1%, aimed at treating dry eye disease (DED). The 52-week study, involving 202 patients, demonstrated sustained safety and efficacy of VEVYE, with significant improvements in corneal staining, tear production, and symptomatology. Mild instillation site pain and reduced visual acuity were the most common adverse events. Only one patient withdrew due to mild ocular discomfort. 33.1% of patients rated the eye drop satisfaction at 10, and 91% rated it 5 or higher. Investigators highlighted VEVYE’s tolerability and long-term potential. Harrow’s CEO emphasized the product’s unique formulation and clinical benefits.

Harrow (Nasdaq: HROW), a prominent North American eyecare pharmaceutical company, will participate in two investor conferences in May. The company will attend the B. Riley Securities 24th Annual Institutional Investor Conference at the Beverly Hilton Hotel in Beverly Hills, CA, on May 22-23, 2024. The event includes an in-person Fireside Chat and 1x1 investor meetings.

Harrow will also be present at the Craig-Hallum 21st Annual Institutional Investor Conference at the Depot Renaissance Hotel in Minneapolis, MN, on May 29, 2024, featuring 1x1 and small group investor meetings. Interested investors should contact their B. Riley or Craig-Hallum representative for meeting arrangements. Neither event will be webcast.

Harrow (Nasdaq: HROW) reported its first quarter 2024 financial results, with revenues reaching $34.6 million, a 33% increase from the prior-year quarter. Gross margin was steady at 69%, while net loss increased to $13.6 million from $6.6 million in Q1 2023. Key highlights include IHEEZO's new CMS reimbursement approval, seven new supply agreements, and new patent claims valid through 2039. VEVYE's coverage expanded to 150 million lives, and ImprimisRx returned to quarterly growth. Cash reserves totaled $76 million as of March 31, 2024, with an additional $5.5 million from recent Eton Pharmaceuticals stock sales. Harrow remains focused on expanding its dry eye and retina franchises and stabilizing ImprimisRx.

Harrow, a U.S. eyecare pharmaceutical company, appoints Greg DiPasquale as Senior Vice President, Head of Commercial. DiPasquale brings extensive experience from companies like Regeneron and Novartis, with a track record of growing sales and revenue in the ophthalmic pharmaceutical industry. Harrow aims to leverage DiPasquale's expertise to enhance its leadership structure and drive growth in the North American market.