cyclosporine ophthalmic insert (OTX-CSI) / Ocular Therapeutix - LARVOL DELTA

Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease. (clinicaltrials.gov) - P1/2; N=153; Completed; Sponsor: Ocular Therapeutix, Inc.; Recruiting ➔ Completed; N=110 ➔ 153; Trial completion date: Apr 2022 ➔ Aug 2021; Trial primary completion date: Dec 2021 ➔ Aug 2021

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Dry Eye Disease • Ophthalmology

Phase 1/2 Trial Evaluating a Novel, Hydrogel-Based Cyclosporine Intracanalicular Insert in Subjects With DED (AAO 2021) - "Conclusion Interim results showed OTX-CSI was generally safe and well tolerated, with no AEs observed. Improvements in DED signs and symptoms started Week 2 and were maintained to Week 16."

Clinical • P1/2 data • Dry Eye Disease • Ophthalmology

Safety and Efficacy of a Novel, Hydrogel-Based Cyclosporine Intracanalicular Insert, for the Treatment of Dry Eye Disease - Phase 1 Study (ASCRS-ASOA 2021) - "Clinically meaningful improvements in DED signs and symptoms were seen in all subjects as early as 2 weeks & maintained to 16 weeks. Results support OTX-CSI as a potential sustained release alternative to conventional bid ophthalmic drops dosing for DED"

Clinical • P1 data • Dry Eye Disease • Ophthalmology

Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease. (clinicaltrials.gov) - P1/2; N=110; Recruiting; Sponsor: Ocular Therapeutix, Inc.; Trial completion date: Aug 2021 ➔ Apr 2022; Trial primary completion date: Apr 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Dry Eye Disease • Ophthalmology

[VIRTUAL] Pharmacokinetics of OTX-CSI, a Cyclosporine Intracanalicular Insert, in Surgically Induced Dry Eye Beagle Dogs (ARVO 2021) - P1/2 | "OTX-CSI successfully released cyclosporine into the tear fluid of surgically induced dry eyes of beagle dogs as demonstrated by cyclosporine concentrations greater than or equal to concentrations in healthy eyes. The reduction in tear fluid production (typically seen in dry eye subjects) does not appear to inhibit transport of cyclosporine to the tear fluid in beagle dry eyes. The insert is currently being evaluated for efficacy and safety in a Phase 2, randomized, masked, vehicle-controlled, multicenter clinical trial in subjects with dry eye (NCT04362670)."

PK/PD data • Dry Eye Disease • Ophthalmology

Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease. (clinicaltrials.gov) - P1/2; N=110; Recruiting; Sponsor: Ocular Therapeutix, Inc.; Active, not recruiting ➔ Recruiting; Trial completion date: Mar 2021 ➔ Aug 2021; Trial primary completion date: Nov 2020 ➔ Apr 2021

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Dry Eye Disease • Ocular Infections • Ophthalmology

Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease. (clinicaltrials.gov) - P1/2; N=5; Active, not recruiting; Sponsor: Ocular Therapeutix, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Conjunctivitis • Dry Eye Disease • Ophthalmology

Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease. (clinicaltrials.gov) - P1/2; N=5; Recruiting; Sponsor: Ocular Therapeutix, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Conjunctivitis • Dry Eye Disease • Ophthalmology