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OCULAR THERAPEUTIX, INC.

(OCUL)
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Ocular Therapeutix? Announces Topline Results for Phase 2 Clinical Trial of OTX-CSI for the Treatment of Dry Eye Disease Did Not Meet Primary Endpoint

10/22/2021 | 08:00am EST

Ocular Therapeutix, Inc. announced topline results from its Phase 2 clinical trial of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease (DED). The Phase 2, U.S.-based, randomized, double-masked, multi-center, vehicle-controlled clinical trial of OTX-CSI was designed to evaluate safety, tolerability, durability, and efficacy of two different formulations of OTX-CSI by measuring signs and symptoms of DED in 140 subjects treated in both eyes over approximately 16 weeks (a 12-week study period, with an additional 4-week safety follow-up). In the Phase 2 clinical trial, OTX-CSI was administered to 147 subjects with DED at 15 sites in the U.S. The four groups evaluated in this study were: OTX-CSI for a shorter duration (2-3 months formulation-F1, n=42), OTX-CSI for a longer duration (3-4 months formulation-F2a, n=40), vehicle insert for a longer duration (3-4 months formulation-F2b, n=43) and vehicle insert for a very short duration (1 week formulation-F3, n=22). The study did not show separation between the OTX-CSI treated subjects (both formulations) and the vehicle treated subjects (both formulations) for the primary endpoint of increased tear production at 12 weeks as measured by the Schirmer?s Test. Change from baseline (improvement) in mean Schirmer?s Test scores for the four groups were as follows: OTX-CSI F1: 1.98 mm, OTX-CSI F2a: 1.91 mm, Vehicle F2b: 2.24 mm and Vehicle F3: 3.08 mm. The study did show an improvement compared with baseline in signs of dry eye disease as measured by total corneal fluorescein staining (CFS) and symptoms of dry eye disease as measured by the visual analogue scale (VAS) eye dryness in subjects treated with the OTX-CSI insert (both formulations) starting as early as two weeks after insertion and continuing over the 12 weeks study period. These improvements were not statistically significant compared with vehicle insert (both formulations) for either CFS or VAS eye dryness (severity and frequency) at 12 weeks.


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Financials (USD)
Sales 2021 45,5 M - -
Net income 2021 -21,3 M - -
Net cash 2021 114 M - -
P/E ratio 2021 -11,9x
Yield 2021 -
Capitalization 524 M 524 M -
EV / Sales 2021 9,02x
EV / Sales 2022 5,15x
Nbr of Employees 181
Free-Float 99,6%
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Ocular Therapeutix, Inc. Technical Analysis Chart | OCUL | US67576A1007 | MarketScreener
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Mean consensus BUY
Number of Analysts 7
Last Close Price 6,32 $
Average target price 21,14 $
Spread / Average Target 235%
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Managers and Directors
Antony Mattessich President, Chief Executive Officer & Director
Donald Notman Chief Financial Officer
Charles M. Warden Chairman
Peter Jarrett Chief Scientific Officer
Michael H. Goldstein Chief Medical Officer & Ophthalmology President
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