Here's a look at some of the latest news regarding ophthalmic drugs and therapies from the past week.
- Alimera Sciences, Inc. recently announced patients are now being treated in Italy with ILUVIEN — its sustained release intravitreal implant that is indicated in Europe for the treatment of vision impairment associated with chronic diabetic macular edema (DME). And Alimera also reported it has secured the rights to pursue posterior uveitis, a secondary indication for ILUVIEN, in the European Union (EU), the Middle East and Africa.
- GenSight Biologics announced promising clinical trial results with GS010 after 96 weeks of follow-up in its Phase I/II study. These results reportedly confirm the long-term positive sustained visual acuity gain after two years with a single intravitreal injection of GS010 in patients with Leber’s Hereditary Optic Neuropathy (LHON), especially in those with less than two years of disease onset.
- Inotek Pharmaceuticals Corporation reported top-line results of the Phase 2 fixed-dose combination (FDC) trial of trabodenoson and latanoprost for the treatment of glaucoma. After 28 Days of once-daily morning treatment (QAM), the fixed combination of trabodenoson 3% and latanoprost 0.005% reportedly showed a 1.2 mmHg improvement in intraocular pressure (IOP) reduction compared to the latanoprost 0.005% alone. However, at Day 56, after four additional weeks of treatment and night-time dosing (QPM), no meaningful clinical advantage in IOP reduction for the fixed dose combinations was observed.
- Neurotech Pharmaceuticals, Inc., in collaboration with the Lowy Medical Research Institute (LMRI), announced 24-month results demonstrating that NT-501 delivering Ciliary Neurotrophic Factor (CNTF) has a beneficial effect in patients with Macular Telangiectasia type 2 (MacTel). NT-501 reportedly utilizes the Company’s proprietary Encapsulated Cell Therapy (ECT) platform that can be customized to deliver specific therapeutic molecules to the back of the eye for retinal disease.
- Ocular Therapeutix™, Inc. reported it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA), regarding its resubmission of a New Drug Application (NDA) for DEXTENZA™ (dexamethasone insert) 0.4mg for the treatment of ocular pain following ophthalmic surgery. The CRL states that the FDA has determined that it cannot approve the NDA in its present form. The company also reported it had recently submitted details of a manufacturing equipment change as an amendment to the NDA resubmission.
- Clearside Biomedical, Inc. has enrolled the first patient in a phase 2 clinical trial of CLS-TA for suprachoroidal administration — the company's proprietary suspension formulation of the corticosteroid triamcinolone acetonide, used together with intravitreally administered EYLEA® (aflibercept) for the treatment of diabetic macular edema.
- BioInvent International AB and ThromboGenics NV have agreed to amend their long-standing agreement, which covers the co-development of the novel anti-PlGF monoclonal antibody products TB-403 and THR-317. THR-317 is reportedly being evaluated in a phase II trial in patients with diabetic macular edema.
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