Ocugen Gets FDA Clearance for IND Amendment for OCU400

By Chris Wack

Ocugen shares were up 7% to $1.94 after the company said the U.S. Food and Drug Administration has cleared its Investigational New Drug amendment to initiate a Phase 3 clinical trial of OCU400, a modifier gene therapy product candidate being developed for retinitis pigmentosa.

The stock hit its 52-week high of $2.11 on March 25, and is up 142% in the past 12 months.

The biotechnology company said the Phase 3 study will have a sample size of 150 participants--one arm of 75 participants with the RHO gene mutation and the other arm with 75 participants that are gene agnostic.

In each arm, participants will be randomized 2:1 to the treatment group and untreated control group, respectively.

In the Phase 1/2 OCU400 clinical trial, a multi-luminance mobility testing scale was the primary functional endpoint. For the Phase 3 OCU400 clinical trial, an updated mobility course will be used--luminance dependent navigation assessment -- that includes a wider range of light intensity and Lux Levels with a uniform correlation between Lux level and Lux intensity.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

04-08-24 1032ET