Two current modalities being pursued by the company are intracanalicular inserts, and both intracameral and intravitreal injections.
The minimally invasive inserts reside and react to the moisture within the canaliculus releasing medication and resorbing after a pre-specified amount of time. They are planned to be used with a variety of pharmaceuticals, including prostaglandin analogs and corticosteroids, but could also be used for various other classes of drugs or disease states.
The first in the pipeline (Dextenza) releases 0.4 mg of dexamethasone to the ocular surface over a period of 4 weeks. In phase III trials, the agent has demonstrated statistical superiority over control groups for control of both inflammation and pain in post-cataract patients.2,3,4 The drug product candidate has completed three phase III trials, and the company continues to be committed to pursuing FDA approval.
The hydrogel is being engineered as a sustained-release intracameral injection for delivery of travoprost and for intravitreal injection of both small- and large-molecule treatments, such as tyrosine kinase inhibitors and protein-based anti-vascular endothelial growth factor (VEGF) agents. A recent partnership with Regeneron should also move forward the development of PEG hydrogel-delivery methods for anti-VEGF drugs.
1. Masket S, Hovanesian JA, Levenson J, et al. Hydrogel sealant versus sutures to prevent fluid egress after cataract surgery. J Cataract Refract Surg. 2014;40:2057-2066.
2. Walters T, Bafna S, Vold S, Wortz G, Harton P, et al. Efficacy and safety of sustained release dexamethasone for the treatment of ocular pain and inflammation after cataract surgery: results from two phase 3 studies. J Clin Exp Ophthalmol. 2016. 7:1000572. doi: 10.4172/2155-9570.1000572
3. Ocular Therapeutix. 2016. Ocular Therapeutix announces successful topline results for both inflammation and pain primary efficacy endpoints from phase 3 clinical trial of DEXTENZA. Nov. 14, 2016. http://investors.ocutx.com/phoenix.zhtml?c=253650&p=irol-newsArticle&ID=.... Accessed Feb. 27, 2017.
4. Ocular Therapeutix. 2017. Ocular Therapeutix Announces additional successful results for phase 3 clinical trial of DEXTENZA. Jan 4, 2017. http://investors.ocutx.com/phoenix.zhtml?c=253650&p=irol-newsArticle&ID=.... Accessed Feb. 27, 2017.