Oyster Point begins enrolment for Phase 3 ONSET-2 study of nasal spray
Category: #health  | By Mateen Dalal  | Date: 2019-07-26 |
  • shareshare_icon
  • Twitter
  • Facebook
  • LinkedIn

Oyster Point begins enrolment for Phase 3 ONSET-2 study of nasal spray

The trial is designed to assess the efficacy and safety of OC-01 for treating dry eye disease

Reports confirm that Oyster Point Pharma, a clinical-stage biopharmaceutical company, has recently announced that the first subject has been enrolled in the Phase 3 ONSET-2 clinical study of OC-01 Nasal Spray to treat the symptoms and signs of dry eye disease.

According to CEO and President of Oyster Point Pharma, Jeffrey Nau, Ph.D., M.M.S., after successfully completing the registrational Phase 2b clinical study i.e. ONSET-1, the company has announced the commencement of the second registrational trial, ONSET-2.

It is believed that OC-01 has the potential to change the method used by eye care physicians to treat patients with dry eye disease, owing to the fast onset of action in surging natural tear film production, the capability to substantially improve both symptoms and signs of dry eye disease, and a promising tolerability profile.

The innovative delivery of OC-01 as a nasal spray spares the ocular surface and allows the product’s novel mechanism of action, offering unique benefits to patients and eye care practitioners.

Reportedly, the ONSET-2 clinical trial is a double-masked, randomized, multicentre, placebo-controlled clinical study to assess the efficacy and safety of OC-01 nasal spray for treating the symptoms and signs of dry eye disease.

The study, which will recruit around 750 subjects at around 20 U.S. centers, will investigate two dosages of OC-01 nasal spray, 1.2 mg/ml, and 0.6mg/ml, as compared to placebo nasal spray. The pre-specified primary endpoint of the clinical trial will be the evaluation of tear production as calculated by the percentage of subjects showing a 10 mm or bigger change at week 4 from baseline Schirmer’s Score.

A member of medical advisory board of Oyster Point Pharma and an ophthalmologist at Virginia Eye Consultants, Elizabeth Yeu, M.D., stated that it is inspiring to view the progress Oyster Point is achieving in the development of OC-01. There is a substantial requirement for therapeutic options that can successfully benefit a wide population of patients with dry eye disease.

 

Source Credits: https://oysterpointrx.com/oyster-point-pharma-announces-enrollment-of-first-subject-in-phase-3-clinical-trial-of-nasal-spray-for-dry-eye-disease/

  • shareshare_icon
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal     twitter

Mateen Dalal

A qualified electronics and telecommunication engineer, Mateen Dalal embarked on his professional journey working as a quality and test engineer. Harnessing his passion for content creation however, Mateen pens down industry-rich articles for ReportsGO.com and a few o...

Read More..

More News By Mateen Dalal

Microsoft investigates Teams and Outlook outage that left users disrupted

Microsoft investigates Teams and Outlook outage that left users disrupted

By Mateen Dalal

Microsoft, the U.S.-based technology frontrunner, reportedly investigating an outage that prevented thousands of customers from accessing services like Teams and Outlook. Apparently, the tech giant did not disclose the number of users that were im...

UK: Budget & basic items’ cost in supermarkets soar 20.3% in December

UK: Budget & basic items’ cost in supermarkets soar 20.3% in December

By Mateen Dalal

Britishers who rely on the budget-friendly aisles of supermarkets reportedly saw the biggest increases in food prices in the months leading up to Christmas, significantly outpacing those for luxury as well as premium brands, as per a survey. Accor...

Sun Cable shuts as $21B solar project to power S’pore hangs in balance

Sun Cable shuts as $21B solar project to power S’pore hangs in balance

By Mateen Dalal

Sun Cable, the Singapore-based solar energy company, has reportedly entered voluntary administration, despite the financial support it received from billionaire investors. The company was supposed to be working on a A$30 billion (US$21 billion) solar...