Research & Development
First Patient Dosed in Phase 2 Clinical Trial of OTX-DED for the Short-Term Treatment of the Signs and Symptoms of Dry Eye Disease
2 March 2021 - - US-based biopharmaceutical company Ocular Therapeutix, Inc. (NASDAQ: OCUL) has dosed the first patient in its Phase 2 clinical trial of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of the signs and symptoms of dry eye disease, the company said.

The Phase 2 clinical trial is a US-based, randomized, double-masked, vehicle-controlled, multi-center trial evaluating two different-strength formulations of OTX-DED (dexamethasone intracanalicular ophthalmic insert) in a total of approximately 150 subjects with dry eye disease.

This trial is designed to assess the safety and efficacy of these two formulations of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease by evaluating bulbar conjunctival hyperemia, corneal fluorescein staining eye dryness symptoms using visual analog scale, and other secondary endpoints in comparison with a matched vehicle control hydrogel insert.

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.

The global market for dry ocular surface disease, which we refer to as dry eye disease, was estimated by Market Scope at USD 5.1bn in 2019 with the US market representing USD 2.1bn.

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 (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery.

Ocular Therapeutix has also submitted a Supplemental NDA for Dextenza to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication.

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.