Ocular Therapeutix, Inc. (NASDAQ: OCUL) stock declined by 36.2% at the last close whereas the OCUL stock price gains by 0.15% in the pre-market trading session. Ocular Therapeutix is a pharmaceutical business that uses its patented bioresorbable hydrogel-based formulation technology to research, test, and commercialize new medicines for illnesses and disorders of the eye.
OCUL stock’ Current Update
Topline data from Ocular Therapeutix’s Phase 2 clinical study of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye condition were released (DED).
The goal of Phase 2 OTX-CSI clinical study in the United States was to assess the safety, tolerability, durability, and effectiveness of two distinct formulations of OTX-CSI by assessing signs and symptoms of DED in 140 patients who were treated in both eyes for around 16 weeks. OTX-CSI was given to 147 patients with DED at 15 sites across the United States in Phase 2 clinical research. In this study, four groups were assessed:
- For a shorter period of time (2-3 months formulation-F1, n=42), OTX-CSI was used.
- For a longer period of time (3-4 months formulation-F2a, n=40), OTX-CSI was used.
- For a longer-term (3-4 months formulation-F2b, n=43), a vehicle insert was used.
- For a relatively brief time (1 week formulation-F3, n=22), a vehicle insert was used.
The primary endpoint of higher tear production at 12 weeks as determined by Schirmer’s test did not demonstrate a difference between the OTX-CSI treated participants (both formulations) and the vehicle-treated subjects (both formulations) in the research.
However,
Ultimately, the safety profile of the OTX-CSI insert (both formulations) was found to be good, and it was well tolerated. There were no significant ocular side effects. There were no withdrawals from the study owing to adverse events. Ocular pruritis was the most prevalent ocular adverse event, occurring in fewer than 16% of participants. Ocular discomfort or pain occurred in less than 3% of the individuals. COVID-19 was the most prevalent non-ocular incident, which was seen in 3% of the participants.
