Here's a look at some of the latest news regarding ophthalmic drugs and therapies from the past week.
- Yesterday, Bausch + Lomb and Nicox SA announced the results of a Phase 3 study for latanoprostene bunod (LBN) ophthalmic solution 0.024% had been published in the American Journal of Ophthalmology, reportedly demonstrating significantly greater efficacy vs. timolol maleate 0.5%. LBN 0.024% is an intraocular pressure (IOP) lowering single-agent eye drop dosed once daily for patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
- Nicox SA also announced this week an agreement with GHOH Capital to transfer its European and international commercial operations to a newly-founded private company focused on the commercialization of a portfolio of ophthalmic products in Europe. Nicox will reportedly continue to focus resources on its unencumbered R&D pipeline in ophthalmology.
- Quethera — a gene therapy spin-off of the University of Cambridge — is reportedly developing a gene therapy to control glaucoma long-term with just a single injection. Current research is being conducted on improving the dynamics of the gene therapy, with plans to advance it into more sophisticated animal models of glaucoma to test its effectiveness.
- Earlier this week, pSivida Corp. announced the completion of two animal studies on an injectable, sustained-release insert utilizing the company's Durasert™ technology to deliver a tyrosine kinase inhibitor (TKI) for treatment of wet age-related macular degeneration (AMD). On the basis of these studies, pSivida plans to advance toward clinical trials of the Durasert TKI insert for wet AMD, including toxicology studies necessary for an investigational new drug application (IND).
- Biopharmaceutical company Omeros Corporation has completed enrollment in the post-marketing pediatric clinical trial that is expected to provide extended market exclusivity of its commercial product Omidria® (phenylephrine and ketorolac) 1%/0.3%. The FDA has approved Omidria for use in adult patients undergoing cataract or intraocular lens replacement surgery to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain.
- Can-Fite BioPharma Ltd. recently announced its subsidiary, OphthaliX, had released top-line results from its Phase II clinical trial of CF101 for the treatment of glaucoma. The clinical trial had been designed to evaluate the safety and efficacy of CF101 when administered orally twice daily for up to 16 weeks in patients with elevated IOP.
- Shire plc recently announced its Phase 2 study evaluating an investigational protein replacement, SHP607, did not meet its primary endpoint of reducing the severity of retinopathy of prematurity (ROP). However, the study reportedly demonstrated clinically relevant effects in secondary endpoints related to the development of severe bronchopulmonary dysplasia (BPD) and severe intraventricular hemorrhage (IVH), both of which have lifelong negative implications for normal development.