
Here's a look at some of the latest news regarding ophthalmic drugs and therapies from the past week.
- EyeGate Pharmaceuticals, Inc. has submitted an Investigational Device Exemption (IDE) for the lead product in its cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S) platform, EyeGate Ocular Bandage Gel (EyeGate OBG). The IDE, if accepted, will enable EyeGate to initiate a second pilot study of EyeGate OBG for the acceleration of re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (PRK).
- Aldeyra Therapeutics, Inc. has enrolled the first patient in a Phase 3 clinical trial of topical ocular ADX-102 for the treatment of noninfectious anterior uveitis (NAU). The Phase 3 clinical trial is reportedly expected to enroll up to 100 NAU patients with active disease, randomized equally to receive either 0.5% topical ocular ADX-102 or vehicle for four weeks, with results expected in the second half of 2018.
- Kala Pharmaceuticals, Inc. reported positive top-line results from its confirmatory Phase 3 trial of KPI-121 1% for the treatment of inflammation and pain in patients who have undergone cataract surgery. KPI-121 1% dosed twice-a-day for two weeks reportedly achieved statistical significance versus placebo for both primary efficacy endpoints and all secondary endpoints, and it was well tolerated with no significant treatment-related safety findings observed during the trial.
- ProQR Therapeutics N.V. announced it has been cleared to start the Phase 1/2 trial for QR-110, named PQ-110-001, in Leber’s congenital amaurosis Type 10 (LCA 10) patients. QR-110 is a novel investigational RNA therapeutic targeting LCA 10 due to the p.Cys998X mutation — a severe genetic rare disease that causes children to lose sight in the first years of life.
- And Aptar Pharma and Kali Care have announced that they entered into a partnership in order to address the challenge of monitoring adherence in ophthalmic clinical trials. Kali Care reportedly provides a revolutionary sensor technology which allows clinicians to replace adherence assumptions in clinical trials with collected real-time data.
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