Ocular Therapeutix Inc. (OCUL:NASDAQ) yesterday announced "preliminary unaudited net product revenue for the Q4/19 and interim results from its Phase 1 clinical trial for OTX-TKI, a long-acting tyrosine kinase inhibitor intravitreal implant being evaluated for the treatment of wet age-related macular degeneration and other retinal diseases."
The company reported that in Q4/19 total net product revenue was $2.3 million, which represents a 172% sequential increase over Q3/19. The firm highlighted that net product revenue of DEXTENZA® in Q4/19 was $1.6 million, compared to $0.3 million in Q3/19. Total Q4/19 net product revenue includes $0.7 million in net product revenue from the company's ReSure® Sealant. The company stated that it plans to release audited FY/19 results later this month.
The company indicated that DEXTENZA net revenue in Q4/19 was driven by continued increase in the number of new accounts prescribing DEXTENZA and re-order rates by existing accounts and that the firm continues to see increased interest from larger accounts since the beginning of 2020.
The firm advised that it expects that Q1/20 net revenues from DEXTENZA sales will be in the range of $2.4-2.6 million and anticipates net revenues from ReSure Sealant of approximately $0.6 million in the same period. Thus, total net product revenue for Q1/20 is expected to be in the range of $3.0-3.2 million.
The company's President and CEO Antony Mattessich commented, "We are pleased with our progress and with the results we are seeing in the early stages of the DEXTENZA launch...Increases in new accounts, re-order rates, and average order size are all metrics we are seeing that reinforce our belief that DEXTENZA's differentiated product profile is resonating with surgeons as a novel treatment for ocular inflammation and pain following ophthalmic surgery. In addition, with encouraging interim results in OTX-TKI for the treatment of wet age-related macular degeneration and in OTX-TIC for the treatment of glaucoma that were announced today and a few weeks ago respectively, we are beginning to see the potential of our early-stage product pipeline."
The firm also provided an interim update Phase 1 trial data on OTX-TKI. The Phase 1 dose escalation clinical trial has enrolled 12 patients split into 2 cohorts and is being conducted in Australia to evaluate the safety and efficacy of OTX-TKI for the treatment of wet age-related macular degeneration.
The firm's Chief Medical Officer Dr. Michael Goldstein added, "For patients with wet age-related macular degeneration and retinal diseases, there is a need for both products with new mechanisms of action and for products that are able to provide longer-acting therapy than current anti-VEGF products on the market today...Initial data from this Phase 1 study with a tyrosine kinase inhibitor indicate that OTX-TKI has the potential to decrease intraretinal and subretinal fluid in patients with wet-age-related macular degeneration...The safety and biological activity seen in this trial is consistent with our pre-clinical animal studies and the data support both ongoing testing as a monotherapy and in combination with other anti-VEGF injections where OTX-TKI could extend the efficacy of those products thereby requiring less frequent dosing."
The company explained that "OTX-TKI (tyrosine kinase inhibitor implant) is a preformed, bioresorbable hydrogel that contains TKI particles in an injectable fiber that can be delivered through a small-gauge, sterile injection needle to the back of the eye."
Ocular Therapeutix is based in Bedford, Mass., and describes itself as "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."
The company noted that "its first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery and that it is conducting a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis." In addition, the company is testing its OTX-TP (intracanalicular travoprost insert) in a Phase 3 clinical trial for reducing intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension.
Ocular Therapeutix began the day with a market capitalization of around $262.5 million with approximately 48.08 million shares outstanding and a short interest of about 11.80%. OCUL shares opened higher today at $5.65 (+$0.19, +3.48%) over yesterday's $5.46 closing price and reached a new 52-week high price this morning of $7.33. The stock has traded today between $5.44 and $7.33 per share and is currently trading at $7.01 (+$1.55, +28.39%).[NLINSERT]
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