Ocular Therapeutix™ Outlines Development Strategy for Its Sustained Release Intravitreal Depots to Address Serious Retinal Diseases

BEDFORD, Mass.-- Ocular Therapeutix, Inc. (OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, today provided an update on the Company’s development strategy for its sustained release intravitreal depot technology for the treatment of serious retinal diseases.

 

The Company is currently developing proprietary sustained-release hydrogel-based drug delivery depots for intravitreal injection that can be formulated with both small and large molecule pharmaceuticals, such as tyrosine kinase inhibitors (TKIs) and protein-based anti-vascular endothelial growth factors (VEGFs) respectively, with the goal of delivering sustained and therapeutic levels of drugs to targeted ocular tissues. The goal of the Company’s intravitreal depot dual development program is to reduce the frequency of injections that are currently the standard of care for the treatment of wet AMD, DME and other retinal diseases.

Accordingly, Ocular Therapeutix also announced today that it has entered into a strategic collaboration, option and license agreement with Regeneron Pharmaceuticals for the development of a sustained release formulation of Regeneron’s VEGF trap, aflibercept, for the treatment of wet age-related macular degeneration (wet AMD) and other serious retinal diseases. Regeneron’s aflibercept is currently approved by the U.S. Food and Drug Administration (FDA) for certain indications under the brand name EYLEA®. Per the agreement, Ocular Therapeutix retains all rights to develop its sustained-release hydrogel-based drug delivery platform with all other non-VEGF targeting compounds as well as with small molecule pharmaceuticals, including TKIs, for other retinal diseases.

 

“In preclinical studies completed to date, we have demonstrated up to 6 months of sustained release of anti-VEGF drugs using our hydrogel-based drug delivery technology with a good safety profile,” stated Dr. Jon Talamo, Chief Medical Officer of Ocular Therapeutix. “A 4-6-month sustained release formulation has the potential to advance the current standard of care in wet AMD and other retinal diseases by significantly reducing injection frequency. We have also demonstrated minimal inflammatory response in vivo through 26 weeks with both our anti-VEGF protein and TKI depots currently in development. This technology represents an exciting development in the field of ophthalmology and we look forward to further advancing these programs.”

 

Presentation at 2016 Ophthalmology Innovation Summit (OIS)

 

Ocular Therapeutix has been selected to present during the Posterior Segment Company Showcase at the 2016 Ophthalmology Innovation Summit (OIS). Dr. Amar Sawhney, President, Chief Executive Officer and Chairman, will provide an overview of recent progress from the Company’s ongoing intravitreal depot development programs today, October 13, 2016 at 11:42am CDT at the Hyatt Regency Chicago Hotel in Chicago, Illinois.

 

Commonly referred to as OIS@AAO, the summit is held each year in conjunction with the American Academy of Ophthalmology (AAO) Annual Meeting.

 

Conference Call & Webcast Information

 

Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 8:30 am Eastern Time to discuss recent progress from the Company's intravitreal depot development programs, as well as the collaboration with Regeneron, which was also announced this morning.

 

The live webcast and accompanying slide presentation can be accessed by visiting the investor section of the Company’s website at investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call 844-464-3934 (U.S.) or 765-507-2620 (International) to listen to the conference call. The conference ID number for the live call will be 98223266. An archive of the webcast will be available until October 27, 2016 on the Company’s website.

 

About Ocular Therapeutix, Inc.

 

Ocular Therapeutix, Inc. (OCUL) is a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary hydrogel platform technology. Ocular Therapeutix has submitted an NDA for post-surgical pain for its lead product candidate, DEXTENZA™ (dexamethasone insert, extended release), which is in Phase 3 clinical development for post-surgical ocular inflammation and pain and allergic conjunctivitis, and in Phase 2 clinical development for dry eye disease. OTX-TP (sustained release travoprost) is in Phase 3 clinical development for glaucoma and ocular hypertension. Ocular Therapeutix is also evaluating sustained-release injectable drug depots for back-of-the-eye diseases. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery. For additional information about the Company, please visit www.ocutx.com.

 

Forward-Looking Statements

 

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the potential benefits and future operation of the collaboration with Regeneron, including any potential future payments thereunder, the ongoing development of the Company’s sustained release hydrogel depot technology, the development and regulatory status of the Company’s other product candidates, such as the Company’s expectations and plans regarding regulatory submissions for and the timing and conduct of clinical trials of DEXTENZA™ for post-surgical ocular inflammation and pain, including our expectations regarding the NDA filed with the FDA, DEXTENZA for the treatment of allergic conjunctivitis, DEXTENZA for dry eye disease and OTX-TP for the treatment of glaucoma and ocular hypertension, the potential utility of any of the Company’s product candidates, potential commercialization of the Company’s product candidates, the sufficiency of the Company’s cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the timing and costs involved in commercializing ReSure® Sealant or any product candidate that receives regulatory approval, the initiation and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company’s scientific approach and general development progress, the availability or commercial potential of the Company’s product candidates, the sufficiency of cash resources and need for additional financing or other actions and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release.