Ocugen has commenced the first of its two Phase lll clinical trial to evaluate the efficacy of OCU300 for the treatment of ocular discomfort and redness in patients with ocular graft versus host disease (oGVHD).

The pivotal trial is result of a new investigational new drug (IND) application submitted by Ocugen to the US Food and Drug Administration (FDA).

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

The randomised, double-masked, placebo-controlled trial seeks to enrol around 60 patients.

As part of the study, the patients will be randomised in ratio of 2:1 to receive OCU300 or placebo (ophthalmic saline).

The patients will also be given daily eye drops of their assigned treatment for a period of 84 days.

Primary efficacy objectives of the trial will gauge ocular discomfort using the visual analog scale (VAS) and ocular redness using the Validated Bulbar Redness (VBR) grading scale.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
“As we begin enrolling oGVHD patients in this study, we look forward to continuing that efficiency and reporting top-line data as soon as it is available.”

Ocugen chairman, CEO and co-founder Shankar Musunuri said: “As we begin enrolling oGVHD patients in this study, we look forward to continuing that efficiency and reporting top-line data as soon as it is available, which we currently expect to be in the second half of 2019.

“We also expect to launch pivotal studies for our second lead candidate, OCU310 for the treatment of dry eye disease, later this year.”

OCU300 contains FDA-approved brimonidine tartrate formulated in a nanoemulsion developed using Ocugen’s patented OcuNanoE technology.

It is currently being developed to treat ocular discomfort and redness in patients with oGVHD, a severe ophthalmic comorbidity that is estimated to affect nearly 60% of patients who undergo allogeneic bone marrow transplant.

There is currently no approved treatment available for the disease.