Here's a look at some of the latest news regarding ophthalmic drugs and therapies from the past week.
- Glaukos Corporation has acquired the intraocular pressure (IOP) sensor system assets and related liabilities from DOSE Medical Corporation. The DOSE Medical IOP sensor system will reportedly complement Glaukos' fundamental strategy to transform glaucoma therapy with micro-scale device and drug-delivery platforms that can ultimately address a full range of disease state severity. Additionally, Glaukos announced a study published in Clinical Ophthalmology showed that two iStent® Trabecular Micro-Bypass Stents and one topical ocular hypotensive medication achieved a 38% reduction in mean medicated IOP three years following surgery in 37 phakic eyes.
- Aerie Pharmaceuticals, Inc. reported successful six-month topline safety and efficacy results of its Rocket 4 Phase 3 clinical trial for product candidate Rhopressa™ — a novel once-daily eye drop being tested for its ability to lower IOP in patients with glaucoma or ocular hypertension. The Rocket 4 trial was reportedly designed to provide six-month safety data adequate for European regulatory filing purposes. Rocket 4 was reportedly not necessary for U.S. NDA (New Drug Application) filing purposes, although data from the 90-day efficacy component of the trial was included in the February 2017 Rhopressa NDA submission as supportive.
- Nicox S.A. announced the U.S. FDA has set a PDUFA date of September 8, 2017 for its decision on the NDA for ZERVIATE1 (cetirizine ophthalmic solution) 0.24% — Nicox’s novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis.
- Eyevensys has received approval from the French product security regulatory agency “Agence Nationale de Sécurité du Médicament” (ANSM) to advance its technology into clinical development. Eyevensys' proprietary EyeCET platform is reportedly the first non-viral gene expression technology that enables the safe, local, sustained production of therapeutic proteins in the eye to address a wide range of ophthalmic diseases.
- Inotek Pharmaceuticals Corporation has completed the active recruitment phase of the Phase 2 dose-ranging trial of a fixed-dose combination (FDC) of trabodenoson and latanoprost for the treatment of glaucoma. Top-line data from the FDC study are reportedly expected in July.
- Shire plc announced a new collaboration with personalized health network PatientsLikeMe to develop a patient-centered, real world health learning system to help expand understanding of patient health and disease.
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