The FDA has given Ocugen orphan drug status for a gene therapy designed to treat NR2E3 mutation-associated retinal degenerative disease.
Dr. Shankar Musunuri, Ph.D., MBA, is Chairman of the Board, CEO and Co-founder of Ocugen, Inc., discusses the Company’s lead clinical candidate (OCU300) that is currently in Phase 3 for patients with ocular graft versus host disease (oGVHD) and is the first and only therapeutic with orphan drug designation for oGVHD, and the Company’s second lead candidate (OCU310) which is also in Phase 3 for patients with dry eye disease.
Ocugen said today that it launched a Phase III trial designed to evaluate its twice-daily 0.2% brimonidine tartrate eye drop in patients with dry eye disease.
To the layperson, dry eye disease (DED), technically xerophthalmia, often is dismissed as an innocuous nuisance that can be treated with over-the-counter eye drops.
Ocugen said today that it launched the first of two pivotal Phase III trials for its OCU300 nanoemulsion designed to treat the symptoms of ocular graft versus host disease.
Biotech hopes to counter established Restasis and Xiidra in dry eye with a combination of two approved
ophthalmology eye drops, offering quicker onset of action, tolerability and strong efficacy.
Eye disease specialist Ocugen remains on course to have two drugs in late-stage testing before the end of the year as its dry eye disease candidate OCU310 clears a phase 2 trial.
While Allergan PLC and Shire PLC are jockeying for supremacy in the dry eye disease space, with the former's Restasis (cyclosporine ophthalmic emulsion) losing market share to the latter's Xiidra (lifitegrast), a host of other companies have candidates in clinical development for dry eye addressing a wide variety of targets in the hopes of bettering the existing therapies or benefiting an underserved niche.
Shankar Musunuri has spent time in both the pharmaceutical world and the biotech arena – after 15 years at Pfizer (NYSE:PFE), he went on to launch several biotech start-ups. As co-founder, chairman & chief executive of Ocugen, he is looking to bring eye disease products to the patients that big pharma’s drugs have left out.
Ocugen CEO Dr. Shankar Musunuri Named a 2017 ‘Most Admired CEO’ by the Philadelphia Business Journal
Ocugen, Inc., a rapidly growing ophthalmology company developing a rich clinical pipeline of innovative therapies and novel biologics that address rare and underserved ocular diseases, today announced its Co-Founder, Chairman and Chief Executive Officer Shankar Musunuri, Ph.D., MBA, was named one of the “Most Admired CEO’s in 2017” by the Philadelphia Business Journal.