Ohr Pharmaceuticals' MAKO study utilizing Squalamine and Lucentis does not meet primary endpoint

(c) AAO

Ohr Pharmaceutical, Inc. has reported topline data from the MAKO study that did not meet its primary efficacy endpoint. The study evaluated efficacy and safety of topically administered squalamine in combination with monthly Lucentis® injections for the treatment of wet age-related macular degeneration. The primary efficacy endpoint was the mean visual acuity gain at nine months, using a mixed-effects model for repeated measures (MMRM) analysis.

Suprachoroidal injection - Clearside's approach to treating Diabetic Macular Edema

(c) NEI

Clearside Biomedical, Inc. has completed patient enrollment in the Phase 2 clinical trial (referred to as "TYBEE") of CLS-TA, the company's proprietary suspension formulation of the corticosteroid triamcinolone acetonide (TA) for suprachoroidal administration, used in combination with intravitreally administered Eylea^TM (aflibercept) for treatment of diabetic macular edema (DME).  Patient follow-up in the TYBEE trial is 6 months.

Leber Hereditary Optic Neuropathy - The Gene Therapy race to treatment

GenSight Biologics, which is in advanced stages of clinical development of gene therapy for Leber Hereditary Optic Neuropathy, has a new Chief Medical Officer. Barrett Katz, M.D., M.B.A., who until recently was the Professor of Ophthalmology, Neurology and Neurosurgery at the Montefiore Medical Center and the Albert Einstein College of Medicine in New York. Dr. Katz has worked in both academic medicine and the industry as a neuro-ophthalmologist, working as CEO of ophthalmic biotech Danube Pharmaceuticals, as well as CMO of Fovea Pharmaceuticals and VP of medical affairs and strategy at Eyetech.

Biosimilars and clinical care - information for healthcare providers - Part I

A significant number of people, both in clinics and in pharmaceutical industry, mention the fact that they keep hearing of the word 'biosimilars' in academic meetings and in discussions, but they have no idea what they are, and what they do. Considering that biosimilars are likely to affect the way we practice medicine in the days ahead, it is important that we are aware of what biosimilars mean, and what they do. Also, it is important from the pharmaceutical industry perspective that everyone is knowledgeable of the process for an approval. Lastly, there is a minuscule, but very relevant question, about legal implications, which may or may not break your/your company's back in getting the drug to the market! The last two topics will be covered in subsequent posts.