Ophthalmology Therapeutic Roundup — January 5, 2017

Here's a look at some of the latest news regarding ophthalmic drugs and therapies from the past week. 

• Trefoil Therapeutics has entered into a collaborative research and development agreement with the National Institutes of Health's (NIH) National Center for Advancing Translational Services (NCATS) to complete the Investigational New Drug (IND) enabling activities for their lead compound, TTHX1114, toward a treatment for Fuchs endothelial corneal dystrophy (FECD). Trefoil is reportedly developing TTHX1114 as potentially the first medical therapy for treatment of FECD, which is the most common driver of corneal transplantation.
• Ocular Therapeutix, Inc. reported additional positive secondary endpoint results for its most recent phase 3 clinical trial of Dextenza™ (dexamethasone insert) 0.4 mg, for the treatment of post-surgical ocular inflammation and pain. According to the company, about 46 percent of patients in the Dextenza treatment group were show to have an absence of anterior chamber flare at day four after insertion, which Ocular believes provides further support of the early onset anti-inflammation effect of the treatment.
• Sun Pharma has announced successful Phase 3 confirmatory clinical trial results for Seciera™ (cyclosporine A, 0.09% ophthalmic solution) for the treatment of dry eye disease. In a 12-week, multicenter study of 744 dry eye patients treated with either Seciera or its vehicle, those treated with Seciera showed statistically significant improvement in the primary end point Schirmer’s score (p<0.0001), compared to its vehicle.
• Inotek Pharmaceuticals Corporation announced its MATrX-1 first pivotal Phase 3 trial of trabodenoson for the treatment of primary open-angle glaucoma (POAG) or ocular hypertension (OHT) did not achieve its primary endpoint of superiority in reduction of intraocular pressure (IOP) compared with placebo at all 12 time points. However, the company reported MATrX-1 did achieve several clinically meaningful secondary endpoints, such as the 6 percent dose was significant versus placebo in the daily IOP change from diurnal baseline at all days tested.
• Aerie Pharmaceuticals, Inc. reported it has been notified by its third-party manufacturing vendor that the manufacturing line related to Rhopressa™ in their Tampa, Fl. facility will not be ready for pre-approval inspection by the FDA until the end of February 2017. Aerie reportedly plans to resubmit their Rhopressa NDA filing near the end of the first quarter of 2017 after receiving notification that the manufacturing line is ready for inspection.
• ThromboGenics NV announced the protocol of the Phase II CIRCLE trial evaluating multiple doses of THR-409 to induce a total posterior vitreous detachment in patients with non-proliferative diabetic retinopathy (NPDR) has been amended. The changes will allow inclusion of patients with less severe NPDR, reportedly resulting in a broader patient pool for the study to recruit from.
• And Kubota Pharmaceutical Holdings Co., Ltd. has signed a letter of intent to form a joint venture with SBI Holdings, Inc. that will organize and manage special purpose entities to finance the development of ophthalmic drugs and devices.