The FDA has given Ocugen orphan drug status for a gene therapy designed to treat NR2E3 mutation-associated retinal degenerative disease. The Malvern, Penn.-based company’s OCU400 product includes an adeno-associated virum serotype 5 capsid that contains the gene for human nuclear hormone receptor NR2E3. In a mouse model of NR2E3 mutation, delivery of NR2E3 to retinal […]
Ocugen kicks off dry eye disease trial for nanoemulsion eye drop
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. Ocugen plans to run two identical Phase III trials of OCU310, enrolling 240 participants per study. The company said it will assess safety and efficacy results after just 28 […]
Ocugen launches Ph3 trial for eye disease nanoemulsion
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. The Malvern, Penn.-based company’s drug is a nanoemulsion formulation of brimonidine tartrate made using Ocugen’s OcuNanoE technology. Ocugen touted that it’s the first company to bring […]
Ocugen touts Ph2 data for dry eye disease combo therapy
Ocugen touted positive data today from a Phase II proof-of-concept trial for its dry eye disease combination therapy, OCU310, which combines brimondine tartrate and loteprednol etabonate. The company’s randomized trial met its primary tolerability endpoint and showed meaningful improvements across endpoints related to the symptoms of dry eye disease, according to Ocugen. The Malvern, Pa.-based […]
How this biotech plans to go up against big pharma with its eye disease products
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. “There’s […]
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