Here's a look at some of the latest news regarding ophthalmic drugs and therapies from the past week.
- ProQR Therapeutics N.V. announced its investigational drug QRX-411 has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of retinitis pigmentosa, including Usher syndrome, the subtype targeted by QRX-411.
- Pharma Major Lupin Limited has launched its Moxifloxacin Hydrochloride Ophthalmic solution USP, 0.5% (base) in the United States, having previously received approval from the U.S. FDA. Lupin’s Moxifloxacin Hydrochloride Ophthalmic solution USP, 0.5% (base), is reportedly an AT1-rated generic equivalent of Novartis Pharms Corp.’s Vigamox® Ophthalmic solution, and is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the organisms.
- Verseon presented pharmacokinetic and in vivo efficacy data on its diabetic macular edema (DME) candidates at the 2017 BIO International Conference last week. The data reportedly suggested that Verseon’s drug candidates reduce leakage into the retina and are suitable for topical or oral dosing.
- Pharmaleads has successfully completed a Phase I single ascending dose (SAD) trial in France with its oral DENKI candidate PL265 that is being developed for the treatment of neuropathic pain. PL265 is reportedly also a promising candidate for local administration such as eye drops for ophthalmic pain, for which Pharmaleads is currently completing its evaluation for the treatment of ocular pain and dry eye syndrome in animal models.
- NightstaRx Limited announced the completion of a $45 million Series C financing transaction, which will reportedly be used to fund the upcoming Phase 3 trial for the company's lead product candidate NSR-REP1 for choroideremia, an ongoing Phase 1/2 clinical trial of Nightstar’s product candidate NSR-RPGR for X-linked retinitis pigmentosa, and a planned Phase 1/2 clinical trial of a gene therapy product candidate for an inherited form of macular dystrophy.
- Aerpio Pharmaceuticals, Inc. announced the initiation of patient dosing in the company’s TIME-2b study — a Phase 2b clinical trial designed to assess the efficacy and safety of Aerpio’s lead candidate AKB-9778 for patients with moderate to severe non-proliferative diabetic retinopathy.
- Imprimis Pharmaceuticals, Inc. entered into an agreement to sell its Folcroft, Pennsylvania facility and sinus related assets for $450,000. The move is reportedly in support of Imprimis' commitment to focusing on growing and strengthening its ophthalmology business.
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