Ocugen Secures US FDA Nod of Expanded Access Programme

Ocugen, Inc., a biotech company specializing in innovative gene and cell therapies and vaccines, disclosed that FDA has granted approval to initiate its expanded access program for using OCU400 on adult patients, 18 years and above, with retinitis pigmentosa (RP).

“Each clinical milestone achieved by OCU400 brings us closer to providing a potential one-time treatment for life to patients living with RP,” said Dr. Shankar Musunuri, chairman, CEO, and co-founder of Ocugen. “With positive phase 1/2 study data and an ongoing phase 3 liMeliGhT (pronounced “limelight”) clinical trial, we now plan to work with clinicians, patients, and the RP community to provide access to OCU400 for eligible patients through our EAP. The EAP strengthens our commitment to serving RP patients—300,000 in the US and Europe and 1.6 million globally.”

EAP enables individuals with serious or life-threatening conditions and unmet medical needs to receive treatments that are not yet FDA-approved outside of a clinical trial.

The OCU400 EAP is offered to patients with early to advanced RP having some retinal preservation who could benefit from OCU400's mechanism of action before the Biologics License Application (BLA) is approved. Ocugen is currently administering doses to patients in the phase 3 liMeliGhT clinical trial.