Health and Healthcare

Ocular Therapeutix Skyrockets on Positive FDA Meeting

Chris Lange

Published: February 17, 2016 9:20 am

Last Updated: January 13, 2020 1:06 pm

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.

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.