Here's a look at some of the latest news regarding ophthalmic drugs and therapies from the past week.
- Dompé announced the European Commission has granted the marketing authorization of cenegermin eye drops for the treatment of moderate to severe neurotrophic keratitis. This reportedly makes it the first biotechnological treatment authorized for this specific indication in the Europe Union.
- BioLight Life Sciences Ltd. announced successful results from its glaucoma insert VS101 ("Eye-D latanoprost insert") Phase 1/2a clinical trial, which reportedly demonstrated its ability to lower intraocular pressure (IOP) for a 12-week period, with a favorable safety profile.
- AbbVie reported the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for HUMIRA® (adalimumab) for the treatment of chronic non-infectious anterior uveitis in pediatric patients from two years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
- Genentech, a member of the Roche Group, reported data from the Phase III GiACTA study, which evaluated Actemra®(tocilizumab) in adult patients with GCA, were published in the July 27, 2017 issue of the New England Journal of Medicine. Both the primary and key secondary endpoints of the study were reportedly met, and no new safety signals were observed.
- Spark Therapeutics received a rare pediatric disease designation from the U.S. FDA for investigational LUXTURNA™ (voretigene neparvovec) as a drug for a rare pediatric disease. FDA’s Office of Tissues and Advanced Therapies is reportedly currently reviewing the Biologics License Application (BLA) for LUXTURNA for the treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy under a Priority Review designation with a Prescription Drug User Fee Act (PDUFA) action date of Jan. 12, 2018.
- Santen Pharmaceutical Co. Ltd. and TRACON Pharmaceuticals, Inc. announced that Santen has initiated a Phase 2a clinical study of DE-122 in patients with wet age-related macular degeneration (AMD). The Phase 2a study is reportedly a randomized controlled trial assessing the efficacy and safety of intravitreal injections of DE-122 in combination with Lucentis® (ranibizumab) compared to Lucentis monotherapy in patients with wet AMD.
- BioTime, Inc. reported the Data Safety Monitoring Board (DSMB) has authorized the company to move forward with enrollment for the third patient cohort for its Phase I/IIa OpRegen® clinical trial. The Phase I/IIa clinical trial is reportedly evaluating the safety and efficacy of implantation regimens of OpRegen in the advanced form of dry-AMD.
- Allegro Ophthalmics, LLC has completed a private round of equity financing for $10.7 million. The funding will reportedly be used to reach future corporate milestones. Allegro is reportedly focused on the development of novel therapies to treat vitreoretinal diseases.
- Ophthotech Corporation declared the company is pursuing a strategy to leverage its clinical experience and retina expertise to identify and develop therapies to treat multiple orphan ophthalmic diseases for which there are limited or no treatment options available. Additionally, the company reportedly plans to continue its ongoing age-related retinal programs and its business development efforts to obtain rights to additional products, product candidates and technologies to treat ophthalmic diseases, particularly those of the back of the eye.
- Alimera Sciences, Inc. reported data from an ongoing audit of real-world U.K. clinical practice, published online July 18, 2017 in Eye, show a significant number of patients with chronic diabetic macular edema (DME) met the vision level requirement to drive after receiving a single ILUVIEN® implant.
- And Imprimis Pharmaceuticals, Inc. announced its core patent-pending ophthalmic formulations have now served more than one million patient eyes.
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