This section highlights FDA-related milestones and regulatory updates for drugs developed by Harrow (HROW).
Over the past two years, Harrow has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
IHEEZO, TRIESENCE®, and VEVYE. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
IHEEZO FDA Regulatory Events
IHEEZO is a drug developed by Harrow for the following indication: Chloroprocaine hydrochloride ophthalmic gel.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IHEEZO
- Announced Date:
- July 9, 2024
- Indication:
- Chloroprocaine hydrochloride ophthalmic gel
Announcement
Harrow announced that as of July 1, 2024, it has entered into an agreement with Apexus to make IHEEZO® (chloroprocaine hydrochloride ophthalmic gel) 3% and other Harrow products available through its 340B Prime Vendor Program.
AI Summary
Harrow Inc. announced that beginning July 1, 2024, it has entered an agreement with Apexus to make IHEEZO® (chloroprocaine hydrochloride ophthalmic gel) 3% available through the 340B Prime Vendor Program. Under this agreement, several Harrow products—including IHEEZO®, a low-viscosity topical ocular anesthetic, as well as other eye care treatments like VIGAMOX® and ILEVRO®—will be accessible to U.S. hospitals participating in the program.
This move reinforces Harrow’s commitment to making its innovative products both accessible and affordable, especially for institutions serving vulnerable populations. By leveraging the 340B Prime Vendor Program, managed by Apexus, Harrow anticipates improved distribution and purchasing power for its products, which is expected to benefit many healthcare facilities in managing eye-related emergencies and procedures across the country.
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TRIESENCE® FDA Regulatory Events
TRIESENCE® is a drug developed by Harrow for the following indication: For the treatment of sympathetic ophthalmia, temporal arteritis, uveitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TRIESENCE®
- Announced Date:
- March 11, 2025
- Indication:
- For the treatment of sympathetic ophthalmia, temporal arteritis, uveitis
Announcement
Harrow announced the execution of a five-year strategic supply and development ("SSD") agreement for TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL, a preservative-free synthetic corticosteroid that is approved by the U.S. Food and Drug Administration (FDA) for visualization during vitrectomy and the treatment of ocular inflammatory conditions that are unresponsive to topical corticosteroids.
AI Summary
Harrow HROW has signed a five-year strategic supply and development (SSD) agreement to secure the manufacture of TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL. TRIESENCE is a preservative-free synthetic corticosteroid approved by the FDA for use during vitrectomy procedures to enhance visualization and for treating ocular inflammatory conditions that do not improve with topical corticosteroids. This agreement with its current contract manufacturing organization will ensure that quality and continuous production are maintained, building on over 15 years of experience in making TRIESENCE. By locking in a reliable supply through a trusted manufacturing partner, Harrow aims to meet the ongoing needs of eye care professionals and their patients, supporting effective treatment in ophthalmology while reinforcing its commitment to product quality and consistent availability.
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VEVYE FDA Regulatory Timeline and Events
VEVYE is a drug developed by Harrow for the following indication: For treating both the signs and symptoms of dry eye disease (DED).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VEVYE
- Announced Date:
- April 10, 2025
- Indication:
- For treating both the signs and symptoms of dry eye disease (DED).
Announcement
Harrow announced an expansion of its VEVYE® Access for All("VAFA") program to include patients currently prescribed Klarity-C Drops®, a compounded cyclosporine 0.1% product manufactured and distributed by ImprimisRx®, Harrow's compounding subsidiary.
AI Summary
Harrow, a major North American eyecare pharmaceutical company, has expanded its VEVYE® Access for All (VAFA) program to now include patients using Klarity-C Drops®. Klarity-C is a compounded cyclosporine 0.1% product made and distributed by ImprimisRx®, Harrow’s compounding subsidiary. This program, which originally launched in March 2025, helps reduce access barriers for dry eye treatments by eliminating prior authorization requirements and reimbursement delays. It also offers free home delivery and a money-back guarantee. With this expansion, more than 25,000 patients across the U.S. can switch their prescriptions to VEVYE (an FDA‑approved cyclosporine ophthalmic solution) at a cash price of $59 per bottle, including refills. The new process allows prescribers to convert Klarity-C prescriptions using a quick, five‑minute authorization platform, making the transition smooth and accessible for both patients and healthcare providers.
Read Announcement- Drug:
- VEVYE
- Announced Date:
- March 17, 2025
- Indication:
- For treating both the signs and symptoms of dry eye disease (DED).
Announcement
Harrow today introduced VEVYE® Access for All, a groundbreaking initiative that underscores Harrow's long‑standing commitment to access and affordability.
AI Summary
Harrow, a North American eyecare pharmaceutical company, has launched VEVYE® Access for All, a new program that highlights the company’s commitment to access and affordability. The initiative ensures that eligible patients and health plans can obtain VEVYE (cyclosporine ophthalmic solution) 0.1% for $59, making treatment for dry eye disease more affordable. Available now through PhilRx, a national mail‐order pharmacy partner, the program streamlines the process by eliminating lengthy prior authorization procedures and other bureaucratic delays. Physicians can now prescribe VEVYE without dealing with extra paperwork, while patients benefit from prompt prescription processing and free home delivery. In addition, the program offers further discounts on refills and includes a money‑back guarantee, reinforcing Harrow’s dedication to ensuring that every eligible patient has quick, hassle‑free access to essential dry eye therapy.
Read Announcement- Drug:
- VEVYE
- Announced Date:
- June 5, 2024
- Indication:
- For treating both the signs and symptoms of dry eye disease (DED).
Announcement
Harrow announce results from its ESSENCE‑2 open-label extension (OLE) clinical study for VEVYE® (cyclosporine ophthalmic solution) 0.1%, the first and only cyclosporine to treat the signs and symptoms of dry eye disease (DED).
AI Summary
Harrow recently announced positive results from its ESSENCE‑2 open-label extension study for VEVYE® (cyclosporine ophthalmic solution) 0.1%. The Phase 3 study involved 202 patients using VEVYE twice daily for 52 weeks. The study confirmed that VEVYE showed sustained safety and effectiveness in treating both the signs and symptoms of dry eye disease. Researchers observed statistically significant improvements in various efficacy measures compared to baseline, including improved corneal staining and increased tear production over time, with most side effects being mild. Patient satisfaction was high, with about 91% rating their experience as 5 or higher on a 0 to 10 scale.
The data supports VEVYE as a promising long-term treatment option for chronic dry eye disease, highlighting its unique water-free formulation and excellent tolerability profile.
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