
Amir H. Shojaei, PharmD, PhD, is the chief scientific officer at Harrow, Inc. Dr. Shojaei oversees the company’s medical, clinical, and regulatory affairs as well as pharmacovigilance and QA/compliance for FDA-approved products. Prior to joining Harrow, he held senior leadership roles at several biopharmaceutical companies.
Ophthalmology Management: Can you provide an update on Vevye since its launch?
Amir H. Shojaei, PharmD, PhD: Since the launch of Vevye (cyclosporine ophthalmic solution 0.1%) for the signs and symptoms of dry eye disease (DED) in January 2024, doctors are taking notice of the sustained efficacy of the compound and its good tolerability (shown to promote corneal healing in as little as 15 days with most patients [99.8%] reporting no or only mild stinging and burning on instillation).
Historically, one of the key problems with a cyclosporine-based product has been its tolerability and safety where patients previously experienced a burning and stinging sensation. Vevye is dissolved in a semifluorinated alkane that enhances penetration of cyclosporine through the ocular surface and offers significant advantages over older formulations including efficacy and tolerability. So far, it has been really welcomed by patients, and doctors say they feel confident in this product and that patients can tolerate it. This is something most of us in the dry eye business never thought would happen with cyclosporine.
OM: How will the Vevye Access for All initiative reduce patient barriers to DED therapy?
AHS: Vevye Access for All simplifies dry eye therapy for eligible patients by eliminating access barriers, such as prior authorization and reimbursement delays, as well as high co-pays and affordability issues. The program, which is available through Harrow’s PhilRx specialty pharmacy partner, guarantees access to Vevye for eligible patients and health plans for $59. The program also provides free home delivery and allows patients to choose to use their insurance coverage or to take advantage of Harrow’s cash price. Harrow also expanded this program to include patients currently prescribed Klarity-C Drops, a compounded cyclosporine 0.1% product manufactured and distributed by ImprimisRx, Harrow’s compounding subsidiary. Patients in the United States can convert their Klarity-C prescriptions to Vevye for $59 per bottle (including refills) and have access to a prescription authorization platform to transfer Klarity-C prescriptions to PhilRx.
OM: Harrow also announced a partnership with Cencora. How will this collaboration make Iheezo and Triesence more accessible and affordable?
AHS: The Harrow Cares program is tailored to provide many services that are similar to the Vevye Access for All initiative, but for our retinal suite of products: Iheezo (chloroprocaine hydrochloride ophthalmic gel) 3%, indicated for ocular anesthesia, and Triesence (triamcinolone acetonide injectable suspension) 40 mg/mL, for visualization during vitrectomy and for the treatment of ocular inflammatory conditions that are unresponsive to topical corticosteroids. The program helps retina specialists/their staff determine what benefits the patient has in real time, who qualifies, and what kind of limitations they have with respect to reimbursement or affordability. And then, depending on what kind of limitations the patient has with their insurance, Harrow has an in-house program that will assist with their co-pay.
OM: Harrow has provided recent updates on Triesence, including a supply and development agreement and CMS approval of expanded reimbursement. Can you speak to this?
AHS: For nearly 4 years, Triesence couldn’t be manufactured and was on the FDA Drug Shortage List, until Harrow purchased the compound in 2024. Through a 5-year strategic supply agreement with a well-established ophthalmic pharmaceutical manufacturer, we are ensuring the continued production of Triesence. In addition, the CMS has approved Harrow’s transitional pass-through payment application for Triesence. Effective April 1, 2025, and for the following 3 years, Triesence will be eligible for separate reimbursement—outside of the surgical bundled payment—in both ASC and hospital outpatient department (HOPD) settings. This designation makes Triesence the only FDA-approved, preservative-free synthetic corticosteroid indicated for use during vitrectomy, treatment of uveitis, and ocular inflammatory conditions unresponsive to topical steroids—with reimbursement access across all key care settings: the ophthalmologist’s office, the ASC, and the HOPD. OM