Jumble Of Endpoints For Ophthalmic Surgery Analgesics Coming Into Focus At Panel Session
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's Dermatologic and Ophthalmic Drugs Advisory Committee may help provide guidance in the increasingly competitive therapeutic space of postoperative ocular pain.
You may also be interested in...
Bromday Battle Broadens: Ocular Drug Infection Risks, Fill Size Limits Will Get FDA Cmte. Scrutiny
The Dermatologic and Ophthalmic Drugs Advisory Committee will meet Feb. 27 to discuss issues at the heart of Bromday marketer ISTA Pharmaceuticals’ dispute with the Center for Drug Evaluation and Research over post-operative use of a single-bottle ophthalmic agent in both eyes.
The New Ophthalmic Drug Players
Unmet medical need and market size continue to drive venture investors to ophthalmic drug plays focused on diseases that blind. This interest is fueled by a stable pool of acquirers and the ability to in-license innovative, clinically validated compounds, providing VCs with a jump start to a potential exit.
Janssen’s Sirturo Needs Minor Tweaks To Confirmatory Trial, FDA Panel Says
Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.