Ocular Therapeutix™ Announces First Patients Dosed in Phase 2 Clinical Trial of OTX-CSI for the Treatment of Dry Eye Disease

BEDFORD, MA, USA I September 29, 2020 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 patients in its Phase 2 clinical trial of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease.

“Having successfully completed the Phase 1 study, we are excited to have recently begun dosing patients in the Phase 2 study of OTX-CSI,” said Michael Goldstein, MD, MBA, Chief Medical Officer. “OTX-CSI represents a novel route of delivering cyclosporine, a drug which has proven efficacy in the treatment of dry eye disease. Using our novel intracanalicular insert allows for preservative-free delivery of a consistent dose of cyclosporine that potentially makes OTX-CSI both less irritating to the ocular surface and faster acting than current standard of care drop therapies. If successfully developed, we believe OTX-CSI has the potential to become a highly differentiated treatment that would provide significant benefit to patients with dry eye disease.”

The Phase 2 clinical trial is a U.S.-based, randomized, masked, multi-center trial evaluating two different formulations of OTX-CSI with vehicle insert in approximately 105 subjects who will be followed for a period of 16 weeks. The enrollment of the Phase 2 trial follows the successful completion of the U.S.-based, open-label, single-center Phase 1 study evaluating the safety, tolerability and durability of OTX-CSI and assessing biological activity by measuring signs and symptoms of dry eye disease in five subjects over approximately 16 weeks. The Phase 2 clinical trial is designed to further assess the safety, tolerability and durability and evaluate the efficacy of OTX-CSI in the treatment of dry eye disease.

About Dry Eye Disease

Dry eye disease is a common, multifactorial disease of the tears and ocular surface that results in symptoms of discomfort (such as burning sensation, itching, redness, stinging, pain and foreign body sensation), visual disturbance, and tear film instability that can cause potential damage to the ocular surface. Inflammation of the lacrimal gland and ocular surface have been shown to play a key role in dry eye disease, resulting in a reduction in tear production. Dry eye disease is one of the most common ophthalmic disorders presenting to clinicians and the Market Scope 2019 Dry Eye Products Market Report estimated that more than 17.2 million adults in the United States have been diagnosed with the disorder, including an estimated 8.6 million classified as having a moderate to severe form of the disease.

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 FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. The Company’s earlier stage development assets currently in Phase 1 trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension, OTX-CSI (cyclosporine intracanalicular insert) for the treatment of the signs and symptoms of dry eye disease and OTX-TKI (axitinib intravitreal implant) for the treatment of retinal diseases. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the treatment of episodic dry eye and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) for an extended-delivery formulation of aflibercept for the treatment of retinal diseases, and Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

SOURCE: Ocular Therapeutix

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