Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Sirion submits sNDA for Durezol in uveitis

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Sirion's sNDA for use of its topical ophthalmic corticosteroid Durezol to treat endogenous anterior uveitis, an inflammation that is the leading cause of blindness in the U.S., has been accepted by FDA and given an Oct. 24 action date, the company announced March 16. The application is supported by a 90-patient non-inferiority study that compared Durezol (difluprednate) dosed four times daily to Allergan's Pred Forte (prednisolone acetate ophthalmic suspension) dosed eight times a day. Not only was Durezol non-inferior to Pred Forte, it proved numerically superior in "almost every efficacy measure," the firm said, adding that 12.5 percent of patients in the Pred Forte group and no patients in the Durezol arm withdrew due to lack of efficacy. The package also contains data from two Japanese Phase III trials conducted by Senju Pharmaceuticals, from which Sirion licensed U.S. rights for Durezol. Durezol won approval in June 2008 for treatment of postoperative ocular inflammation and pain (1"The Pink Sheet" DAILY, June 24, 2008). Auxilium submits Xiaflex: Auxilium has filed the BLA for its orphan biologic Xiaflex (clostridial collagenase) for treatment of Dupuytren's contracture, a condition that affects the connective tissue beneath the skin in the palm that is currently only treatable with surgery. The submission was based on data for 1,082 treated Dupuytren's contracture patients

You may also be interested in...

Sirion’s Durezol Cleared For Post-Op Ocular Use

The first-in-class topical steroid is set to launch in the fourth quarter.

Roche/Genentech Keeps Commitment To External Cancer Innovation

Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.

US FDA Eases Changes For Certain Sterile Injectable Container Closure Materials

To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts