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Exonate and Janssen to Develop Eye Drop to Treat Retinal Vascular Diseases

Exonate has entered into a strategic collaboration agreement with Janssen Pharmaceuticals, Inc., one of the Janssen pharmaceutical companies of Johnson & Johnson. Exonate will work with Janssen Research & Development, LLC scientists to develop an eye drop treatment for retinal vascular diseases such as wet AMD and DME by using mRNA targeted therapies. Exonate has developed small molecules that inhibit the production of pro-angiogenic VEGF through the selective inhibition of serine/threonine-protein kinase (SRPK1)-mediated VEGF splicing. The agreement was facilitated by Johnson & Johnson Innovation. More information can be found at https://www.prnewswire.com/news-releases/exonate-announces-collaboration-with-janssen-to-develop-a-new-eye-drop-for-the-treatment-of-retinal-vascular-diseases-including-wet-age-related-macular-degeneration-amd-and-diabetic-macular-oedema-dmo-300984951.html.

DORC Announces FDA Approval of TissueBlue Orphan NDA for ILM Staining

DORC has received notification from the U.S. Food and Drug Administration (FDA) that their New Drug Application (NDA) for TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% has been approved for use as an aid in ophthalmic surgery by selectively staining the internal limiting membrane (ILM). TissueBlue is injected onto the inner retinal surface, enabling the ILM to be clearly stained and distinguished from unstained retina. More information can be found at www.tissueblue.com.

Genenetech and Roche Begin Trial of PDS for DME

Genentech and Roche have initiated a Phase III clinical trial (PAGODA) investigating the efficacy, safety and pharmacokinetics of the Port Delivery System with ranibizumab (PDS) for treatment of diabetic macular edema (DME). Nearly 550 patients with DME will be randomized to receive either the PDS 100 mg/mL refilled at fixed six-month intervals or monthly intravitreal injections of ranibizumab 0.5 mg. The primary endpoint is change in BCVA from baseline averaged over weeks 48 and 50. The PDS is an innovative, investigational drug delivery system that allows continuous delivery of ranibizumab and thus is intended to reduce the burden of frequent eye injections by allowing people with DME to potentially go several months before needing a refill of the implant, and to address under-treatment that could lead to vision loss. More information can be found at http://www.gene.com.

Paul Tornambe, MD, Has Passed Away

Paul Tornambe, MD, of San Diego, CA, passed away on December 23, 2019, after a long battle with pulmonary fibrosis. He was surrounded by his wife, four children, and son-in-law. Dr. Tornambe helped to invent and popularize pneumatic retinopexy for retinal detachments, was president of several national and international professional societies, and created innovative surgical devices. He started his own practice, Retina Consultants San Diego, in 1978, following education and training at Colgate University, Creighton University, Pacific Presbyterian Medical Center, and Washington University in St. Louis. According to Atul Jain, MD, Dr. Tornambe's friend and practice partner, "Retina was Paul's passion. He was an international leader and legend in the field, with two guiding principles in life: 1) always put the patient first, and 2) follow your passion. Paul's passing is a tragedy to the world of retina. He left us at the top of his game—still seeing patients and operating despite having undergone 2 lung transplants."

Permanent J-code Established for Beovu

Novartis has announced that a permanent J-code has been established for Beovu injection for treatment of wet AMD, effective January 1, 2020. The level II HCPCS code is for “Injection, brolucizumab-dbll, 1 mg”, and will help retina specialists receive reimbursement for use of Beovu. The information is shown on the government website at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/CMS-Level-II-HCPCS-Coding-Decisions-2019-2020-Coding-Cycle.pdf.

Lineage Provides Update on Patient Enrollment in Phase I/IIa Study of OpRegen for Dry AMD

Lineage Cell Therapeutics has announced additional patient data from its ongoing Phase I/IIa clinical study of OpRegen, the company’s retinal pigment epithelium (RPE) transplant therapy, for the treatment of dry AMD. The first Cohort 4 patient treated using both a new subretinal delivery system and the company’s new thaw-and-inject formulation of OpRegen has continued to demonstrate notable improvements in vision, having gained 25 readable letters (or 5 lines) 6 months following administration of OpRegen RPE cells, as assessed by the ETDRS. This represents an improvement in visual acuity from a baseline of 20/250 to 20/100 in the treated eye. A second Cohort 4 patient has been similarly dosed, and though early, the patient has shown a small improvement in visual acuity in the treated eye at just 14 days following treatment. To date, improvements have become most evident approximately three to six months after treatment. Both patients had rapid healing at the surgical site with no unexpected complications or any serious adverse events. More information can be found at https://www.biospace.com/article/releases/lineage-provides-update-on-patient-enrollment-in-phase-i-iia-clinical-study-of-opregen-for-the-treatment-of-dry-age-related-macular-degeneration/.

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