- Trial Phase
- Approved (FDA approval 2022-09-27; marketed)
- Time to Market
- Already approved and on the market (FDA approval dated September 27, 2022).
- Why 3/10
- IHEEZO was FDA-approved on 2022-09-27 and is now a commercial product with no IHEEZO-specific PDUFA or pivotal readout scheduled in the next ~12 months — the only hard dated readout at Harrow (QUELL topline, Q4 2026) belongs to VEVYE, not IHEEZO — so per the rubric an approved, marketed drug with no pending regulatory decision scores 3-5, and IHEEZO is not even Harrow's lead product (VEVYE is), warranting a 3.
Watch H2 2026 quarterly reports for IHEEZO unit demand and the ~25% net price improvement effective July 1, 2026 flowing to revenue, plus the company-wide H2 ramp implied by reiterated $350M-$365M full-year 2026 guidance (H1 revenue was only ~$114.9M). IHEEZO is not the stock's binary — the bigger swing factors are VEVYE/QUELL topline data (Q4 2026) and the TYRVAYA acquisition close, so price IHEEZO as a steady grower, not a catalyst.
Price Chart
Executive Summary
IHEEZO is Harrow, Inc.'s (Nasdaq: HROW) branded chloroprocaine HCl ophthalmic gel 3%, a low-viscosity ocular anesthetic gel used to numb the eye for ophthalmic procedures; it won FDA approval on September 27, 2022 and is commercially marketed. It is a growing but supporting asset inside a portfolio led by VEVYE: Q2 2026 earnings reported record IHEEZO unit demand (+44% sequential, +34% YoY) and a ~25% net price improvement effective July 1, 2026, and three studies (interim randomized patient-experience data plus a large real-world safety analysis) were presented at ASRS 2026. There is no IHEEZO-specific binary catalyst on the calendar, and the company is burning cash (GAAP net loss -$17.3M in Q2 2026, -$18.7M operating cash flow YTD) to fund an aggressive H2 ramp, so the drug reads as a solid commercial grower rather than a stock-moving binary.
How It Works
IHEEZO is a local anesthetic gel for the eye. Its active ingredient, chloroprocaine, temporarily blocks sodium channels on nerve endings in the cornea and conjunctiva, which stops pain signals from reaching the brain — essentially numbing the eye surface so procedures like eye injections or exams are comfortable. It is formulated as a low-viscosity gel so it spreads evenly and stays on the eye instead of running off.
Trial Status
Approved and commercialized since September 2022. No pivotal trials pending for IHEEZO itself; evidence-building continues post-marketing — three studies supporting IHEEZO (and BYOOVIZ) were presented at the ASRS 2026 annual meeting, including interim randomized data suggesting improved patient experience and a large real-world safety analysis (July 20, 2026 press release).
The Two-Sided Case
Upcoming Catalysts
- Q3 2026 earnings (late Oct/early Nov 2026): first full quarter of IHEEZO's ~25% net price improvement, watch unit-demand trajectory
- QUELL trial topline data expected Q4 2026 (VEVYE-related, company-level catalyst)
- TYRVAYA acquisition close, expected H2 2026
- Ongoing real-world and randomized evidence presentations at ophthalmology congresses
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Harrow, Inc. Press Release HROW ·Originating report