Ocular Therapeutix™ Announces First Patient Dosed in U.S.-based Phase 1 Clinical Trial of OTX-TKI for the Treatment of Wet Age-Related Macular Degeneration

First Clinical Trial to Assess a Single OTX-TKI Implant Containing a 600ug Dose

BEDFORD, MA, USA I July 29, 2021 I Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has dosed the first patient in the United States Phase 1 clinical trial of OTX-TKI (axitinib intravitreal implant) for the treatment of wet age-related macular degeneration (wet AMD).

“We are very excited to have recently begun dosing patients in this U.S. trial,” said Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix. “The start of this trial is significant as this will be the first clinical trial that will dose subjects with our single, higher dose, 600 µg implant. While current anti-VEGF treatments are effective, their durability is limited. OTX-TKI has the potential to be a new sustained release administration with 6 months or longer durability and a new mechanism of action for the treatment of patients with wet AMD and other retinal diseases. Based on early data from our Australian Phase 1 clinical trial, OTX-TKI has initially demonstrated acceptable tolerability, preliminary biological activity in some patients and durability for up to six months or longer in some cases.”

The Phase 1 clinical trial in the U.S. is a prospective, randomized, controlled, multi-center trial evaluating a single OTX-TKI implant containing a 600 µg dose of axitinib, compared with a 2 mg dose of aflibercept administered every eight weeks in subjects previously treated with anti-VEGF therapy. This trial is designed to assess the safety, tolerability, and biological activity of OTX-TKI for the treatment of wet AMD. The U.S.-based clinical trial of OTX-TKI is being conducted under an exploratory IND (eIND) application at five sites with a total of 20 randomized subjects: 15 subjects being treated with a single OTX-TKI implant containing 600 µg dose of axitinib in combination with an anti-VEGF induction injection, and 5 subjects being treated at eight-week intervals with a dose of aflibercept.

About Age-Related Macular Degeneration

AMD, a progressive retinal disease that is the leading cause of blindness in adults over the age of 60, is estimated to affect approximately 11 to 15 million people in the U.S. AMD affects the center portion of the retina, called the macula, which is responsible for central vision and color perception. There are two forms of AMD; the dry form, which affects between 85-90% of patients, and the wet form, an aggressive form of AMD which affects the remaining 10-15% of patients. In patients with wet AMD, abnormal blood vessels grow underneath and into the retina. These abnormal blood vessels leak fluid and blood into and beneath the retina, causing vision loss.

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix’s first commercial drug product, DEXTENZA®, is an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a supplemental new drug application for DEXTENZA to include an additional indication for the treatment of ocular itching associated with allergic conjunctivitis. Ocular Therapeutix’s earlier stage development assets currently in Phase 1 clinical trials include OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases and OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. Ocular Therapeutix is currently evaluating each of OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease and OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease in Phase 2 clinical trials. Also, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) is in pre-clinical development as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device to prevent wound leaks in corneal incisions following cataract surgery.

SOURCE: Ocular Therapeutix

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