Ocular Therapeutix Skyrockets on Positive FDA Meeting

By Chris Lange Updated Jan 13, 1:06PM EST · Published Feb 17, 9:20AM EST

Follow 24/7 Wall St. on Google

This post may contain links from our sponsors and affiliates, and Flywheel Publishing may receive compensation for actions taken through them.

Ocular Therapeutix Skyrockets on Positive FDA Meeting — © Thinkstock

Ocular Therapeutix Inc. (NASDAQ: OCUL) led the bulls in early trading indications on Thursday, following a positive meeting with the U.S. Food and Drug Administration (FDA). The company announced the Phase 3 clinical development strategy for its OTX-TP (travoprost) drug product candidate for the treatment of glaucoma and ocular hypertension.

Based on feedback from a recent meeting with the FDA, Ocular Therapeutix plans to begin the first of two planned Phase 3 clinical trials in the third quarter of 2016.

Ocular Therapeutix expects that the FDA will require that OTX-TP show a statistically superior and clinically meaningful reduction of intraocular pressure (IOP), compared to the placebo, as a primary efficacy endpoint.

Amar Sawhney, Ph.D., resident, CEO and chairman, commented:

We are pleased with the outcome of our recent meeting with the FDA to discuss the Phase 3 clinical development plan for OTX-TP. We believe that a direct comparison of OTX-TP with a placebo comparator reflects the simplest and most real world appropriate clinical study design for this product. This meeting was an important milestone for advancing this program into the next stage of its development. We expect to initiate the first of two planned Phase 3 clinical trials in the third quarter of 2016 after holding an End of Phase 2 meeting with the FDA and finalizing the protocol for the trials.

[nativounit]
Robert Noecker, M.D., MBA, Ophthalmic Consultants of Connecticut and Assistant Clinical Professor, Yale University School of Medicine, added:

Compliance remains a major issue with all current glaucoma eye drop therapies. Sustained release drug candidates such as OTX-TP address this issue directly, and have the potential to put the control back into the hands of the physician by removing the burden on the patient to administer eye drops every single day. In clinical trials to date, OTX-TP has shown a clinically meaningful IOP lowering effect and has not caused hyperemia, or eye redness, a common side effect of topical glaucoma therapies… OTX-TP is a product candidate that may offer an important advancement in the treatment of glaucoma.

Shares of Ocular closed Tuesday up 12% at $6.26, with a consensus analyst price target of $40.75 and a 52-week trading range of $5.07 to $44.19. Following the release of the earnings report, the stock was up 42% at $8.89 in early trading indications Wednesday.

About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.