Harrow posts record Q3 revenue, cuts 2026 Adjusted EBITDA outlook
Harrow reported record Q3 2026 revenue, mixed Phase 4 IHEEZO data, and a lowered full-year Adjusted EBITDA target tied to added spending on its G-MELT NDA and TYRVAYA integration.
Harrow, Inc. (Nasdaq: HROW) reported results for the quarter ended September 30, 2026 in a release dated November 9, 2026. Third quarter revenue reached a record $99.3 million, up 41% sequentially and 39% year over year, with branded revenue of $83.5 million, up 62% year over year and about 84% of total revenue.1
The company lowered its full-year Adjusted EBITDA guidance. Full-year 2026 revenue guidance was reaffirmed at $350 million to $365 million, while full-year Adjusted EBITDA guidance was updated to more than $40 million, including fourth-quarter Adjusted EBITDA of more than $33 million, down from prior guidance of $80 million to $100 million.1 Harrow said the updated outlook reflects both a first-half operating shortfall against its original plan and additional spending to accelerate its G-MELT NDA submission, advance development programs, and integrate TYRVAYA.1
On pipeline news, Harrow announced topline results from QUELL, a Phase 4 randomized, double-masked study of 231 patients undergoing intravitreal injections, which did not meet its prespecified primary endpoint of non-inferiority, with successful ocular surface anesthesia in 55.2% of IHEEZO patients versus 59.7% of those receiving proparacaine drops plus subconjunctival lidocaine.1 Secondary findings included lower cumulative pain through 24 hours, less ocular surface staining, and fewer adverse events with IHEEZO, with no serious adverse events in either group.1 Full results are expected at the Hawaiian Eye & Retina Conference in January 2027.1
On regulatory timing, Harrow completed a pre-NDA meeting with the FDA for G-MELT and expects to submit its NDA before the end of the year, earlier than previously anticipated.1 A Phase 3 study of TRIESENCE for ocular inflammation and pain after cataract surgery continues to enroll, with initial data expected in early 2027.1 An ex-U.S. proof-of-concept study of CR-01, a sustained-release conjunctival drug-delivery device for an ocular cancer, has its first patients enrolled and receiving treatment, with initial data expected in the fourth quarter of 2026 and a more robust interim read planned at an Investor Day in New York in March 2027.1
On the TYRVAYA deal, Harrow completed the acquisition of TYRVAYA (varenicline solution) nasal spray 0.03 mg on October 1, 2026, adding about 40 commercial personnel to its Ocular Surface Disease team, with first revenue contribution expected in the fourth quarter of 2026.1
Cash and cash equivalents stood at $75.3 million as of September 30, 2026.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.