brimonidine tartarate nanoemulsion (OCU300) / Ocugen - LARVOL DELTA

Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease (clinicaltrials.gov) - P3 | N=59 | Terminated | Sponsor: Ocugen | Completed ➔ Terminated; Primary endpoint was not met.

Trial termination • Graft versus Host Disease • Immunology • Ophthalmology

Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease (clinicaltrials.gov) - P3; N=61; Completed; Sponsor: Ocugen; Recruiting ➔ Completed

Clinical • Trial completion • Graft versus Host Disease • Immunology • Ophthalmology

Ocugen (OCGN) to discontinue Phase 3 trial of OCU300 for ocular graft vs. host disease (Streetinsider.com) - "Ocugen...today announced the decision to discontinue the Phase 3 trial of OCU300 for ocular Graft vs. Host Disease (oGVHD)....Based on results of a pre-planned interim sample size analysis conducted by an independent Data Monitoring Committee, which indicated the trial was unlikely to meet its co-primary endpoints upon completion. The study was not stopped based on safety concerns."

Trial termination • Graft versus Host Disease • Immunology

Ocugen to present at the 2018 BIO International Convention (PRNewswire) - "Ocugen...announced that it will present at the 2018 BIO International Convention, taking place June 4-7, 2018, in Boston...Ocugen anticipates entering Phase 3 clinical trials in the coming months for its two lead programs in ocular graft versus host disease and dry eye disease."

New P3 trial • Graft versus Host Disease • Immunology

Ocugen to present at the Oppenheimer 28th Annual Healthcare Conference (PRNewswire) - "Ocugen anticipates entering pivotal clinical trials in 2018 for its two lead programs in ocular graft versus host disease and chronic dry eye disease."

New trial • Graft versus Host Disease • Immunology

Ocugen provides business update and first quarter 2020 financial results (GlobeNewswire) - "OCU300 (oGVHD) – Despite the challenges in clinical trial enrollment related to the COVID-19 pandemic, Ocugen completed 100% of the planned enrollment in its Phase 3 trial."

Enrollment closed • Graft versus Host Disease • Immunology

Ocugen provides business update and full year 2019 financial results (Yahoo Finance) - "OCU300 (oGVHD)...as of March 20, 2020, Ocugen has completed over 95% of the planned enrollment. Ocugen is anticipating topline results by the end of the year."

Enrollment status • P3 data: top line

Ocugen Announces Completion of 50% of Enrollment of its Phase 3 Clinical Trial for ocular GVHD (GlobeNewswire, Ocugen) - "Ocugen, Inc,...today announced that it has completed 50% of enrollment of its Phase 3 clinical trial for OCU300 for patients with ocular Graft Versus Host Disease (oGVHD). The ongoing Phase 3 trial is a double-masked, placebo-controlled 84-day trial, in which 60 patients will be randomized in a 2:1 ratio to receive either OCU300 (brimonidine 0.18% nanoemulsion) or a placebo....'We remain on track to report topline results from this trial in the second half of 2020.' "

Enrollment status • P3 data: top line

Ocugen provides business update and third quarter 2019 financial highlights (GlobeNewswire) - "OCU300 (oGVHD) –Enrollment continues in our Phase 3 program for patients suffering from oGVHD. Ocugen anticipates a statistical review in the first half of 2020 to determine any adjustments to sample size."

Enrollment status • P3 data

Ocugen announces share repurchase program (GlobeNewswire) - "Ocugen is also continuing enrollment in its Phase 3 study for OCU300 for ocular graft versus host disease. Ocugen anticipates receiving topline results for the Phase 3 study in the second half of 2020."

Enrollment status • P3 data

Ocugen announces completion of its merger with Histogenics to create Nasdaq-listed clinical-stage company developing novel ocular gene therapies and biotherapeutics (Businesswire) - "Ocugen, Inc....today announced the completion of its merger with Histogenics Corporation...and the change of the combined company’s name to 'Ocugen, Inc.'...'We believe shareholders will benefit from our broad pipeline, which includes OCU300, an orphan drug candidate for ocular graft versus host disease in Phase 3 clinical trials..."

M&A

Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease (clinicaltrials.gov) - P3; N=60; Recruiting; Sponsor: Ocugen; Trial completion date: Jan 2020 ➔ Aug 2020; Trial primary completion date: Jul 2019 ➔ Jul 2020

Clinical • Trial completion date • Trial primary completion date