Dry eye patients gospel! New drug 2 results are positive
March 22, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Ocugen recently announced that its OCU310 clinical phase 2 conceptual validation trial has yielded positive results. OCU310 is a combination of a novel brimondine tartaric acid and a corticosteroid (lotiprifebate) that is being developed for the treatment of dry eye. Ocugen is a rapidly growing ophthalmology company with a wealth of innovative therapeutic research and development pipelines dedicated to the treatment of rare and underserved eye diseases.
About 6% to 34% of adults worldwide suffer from dry eye, and about 16 million people in the United States have dry eye syndrome. The disease is usually associated with dryness and overall eye discomfort as well as stinging, burning or fluctuating blurred vision.
The trial was a randomized, multicenter, double-blind, placebo-controlled study that achieved the primary end point of tolerance within 12 weeks. The results also showed that the symptoms and signs of dry eye were significantly improved in many endpoints compared with placebo. In addition, the overall incidence of adverse events was low, similar to placebo, supporting the safety and tolerability of OCU310. The study did not show statistical significance of the efficacy, but an exploratory efficacy endpoint was pre-specified to assess changes in key symptoms and symptoms of dry eye. Based on these encouraging results, Ocugen plans to advance the OCU310 into Phase 3 clinical studies in the third quarter of 2018.
â–² Dr. Daniel Jorgensen, Chief Medical Officer of Ocugen (Source: Ocugen Official Website)
Dr. Daniel Jorgensen, Chief Medical Officer of Ocugen, said: “We are pleased to achieve our main goal of showing tolerance and continuing to reduce the critical exploratory efficacy endpoints, especially for the potential symptoms of the Phase 3 study. And the end of the sign. We believe that OCU310 can provide significant benefits for patients with dry eye, and we look forward to publishing the full results at future academic conferences and will negotiate with the FDA in the coming months."
â–² Dr. Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen (Source: Ocugen Official Website)
Dr. Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen commented: “We are very excited about these results. We believe that the key potential advantages of OCU310 are its unique potential to alleviate dry eye and potential enhanced tolerance. And support for long-term use. This will make OCU310 popular among prescribers and patients. As we enter Phase 3 clinical studies, we expect to further differentiate OCU310, using our enhanced proprietary nanoemulsion preservative-free brimonidine And the application of loteprednol in disposable vials."
We wish OCU310 a smooth development and early listing, bringing the gospel of treatment to patients with dry eye.
Reference materials:
[1] Ocugen's official website
[2] Ocugen's Dry Eye Treatment Hit Its Primary Endpoint
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