Ocular Therapeutics (NASDAQ:OCUL) is up 34.8% in afternoon trading after announcing that the FDA’s concerns regarding the company’s New Drug Application (NDA) appear to have been addressed.
Based in Bedford, MA, OCUL is a biopharmaceutical company that focuses on the development and commercialization of eye-care products. It has developed DEXTENZA, a treatment meant to be administered for ocular pain following eye-related surgery.
The FDA issued a Complete Response Letter (CRL) to the company’s NDA, citing concerns about deficiencies in OCUL’s manufacturing processes that were observed during an inspection. However there were no concerns stated relating to the safety of the drug.
According to OCUL’s official statement, “one outstanding item remains pertaining to manufacturing process and controls.” The FDA had issued ten inspectional observations in the form, meaning nine have since been settled.
The one concern left pertains to the proposed methodology for testing an inert gas used in the manufacturing process. The FDA requested that OCUL creates a final report when they have moved to technology that is capable of automatically testing the gas, which is anticipated during Q3 2016.
“We are working closely with the FDA to address the one remaining item and are planning for a resubmission to our NDA as soon as possible,” said Amar Sawhney, President, CEO, and Chairman. “We remain committed to bringing DEXTENZA to market as rapidly as possible.”
Analysts have not revised estimates for OCUL in the last 60 days. Current quarter estimates stand at a loss of $0.49 per share, with fiscal year estimates at -$1.78 in earnings per share. Even with today’s rise, OCUL is still trading near its 52 Week Low of $4.04. Stock value has dropped 55.5% year-to-date.
OCULAR THERAPTX (OCUL): Free Stock Analysis Report
Original post
Zacks Investment Research