- Sun Pharma to Acquire Ocular Technologies
Sun Pharmaceutical Industries announced its wholly owned subsidiary would acquire 100 percent of Ocular Technologies Sarl (OTS), a portfolio company of Auven Therapeutics. OTS owns exclusive, worldwide rights to Seciera (cyclosporine A, 0.09% ophthalmic solution). Sun Pharma will pay Auven $40 million upfront, contingent development milestones and sales milestones, and tiered royalty on sales of Seciera. Seciera is currently in a Phase III confirmatory clinical trial for the treatment of dry-eye disease. The patented, novel, proprietary formulation of cyclosporine A 0.09% is a clear, preservative-free aqueous solution. In a completed Phase IIb/III clinical trial in 455 individuals, Seciera demonstrated a rapid onset of action and was well-tolerated by the study population. Based on published data, the efficacy and safety endpoints in these trials compared favorably to other formulations of cyclosporine A. Read more.
- TOPCON Introduces IMAGEnet Connect
Topcon Corp., announced the release of IMAGEnet Connect, a vendor-neutral ophthalmic workflow, image and data management system that seamlessly connects eye-care devices and systems in clinics for streamlined data management. (IMAGEnet Connect is not available for sale in all countries.) To help achieve its Healthcare through the Eye initiative targeting prognostic management and early detection of disease, Topcon acquired ifa—a European company in the ophthalmological electronic medical record systems space—to obtain the platform to accelerate development of IT solutions that can centrally collect and manage data across the eye-care workflow. This includes screening, examination, diagnosis, treatment and prognosis management. IMAGEnet Connect combines Topcon's established hardware technology and ifa's advanced software technology. Topcon says the system goes beyond traditional picture archiving and communication system functionality, providing efficiency in eye care with: a vendor-neutral archive that is compatible with more than 450 devices; clinician view of all clinical information on a single program; efficient workflow management; intelligent patient flow tracking from check-in to check-out; optimized statistics to improve practice workflow and minimize patient waiting time; integrated test interpretations, clinical remarks, diagnosis and treatment plans; intuitive data input with structured data for diagnosis; compliance with ICD-10, SNOMED and LOINC; and a worldwide sales channels and service network. Read more.
- Aerie Pharmaceuticals Reports Positive Topline Results, Withdraws FDA NDA
Aerie Pharmaceuticals reported 90-day topline efficacy results from its Rocket 4 Phase III clinical trial of product candidate Rhopressa, a novel, once-daily eye drop being tested for its ability to lower intraocular pressure in individuals with glaucoma or ocular hypertension. The trial is designed to provide adequate six-month safety data for European regulatory filing purposes, although the trial is not necessary for NDA filing purposes. Rocket 4, which enrolled a total of approximately 700 individuals, is a two-arm, six-month trial, which includes a 90-day efficacy readout evaluating once-daily Rhopressa for non-inferiority to twice-daily timolol. The range for the primary endpoint includes individuals with baseline IOPs from above 20 mmHg to below 25 mmHg. The study achieved its primary efficacy endpoint demonstrating non-inferiority of once-daily Rhopressa compared to twice-daily timolol. Separately, Aerie announced that it withdrew the Rhopressa new drug application submitted to the FDA in the third quarter of 2016 as a result of a third-party manufacturing facility in Tampa, Fla., not being ready for pre-approval inspection by the FDA. The drug product contract manufacturer advised Aerie and the FDA that it expects to be prepared for inspection in January 2017, and Aerie expects to resubmit the Rhopressa NDA filing at that time. Read more.
- Second Sight Implants Wireless Visual Cortical Stimulator in First Human Subject
Second Sight Medical Products announced the first successful implantation and activation of a wireless visual cortical stimulator in a human subject, providing the initial human proof of concept for ongoing development of the company’s Orion I Visual Cortical Prosthesis. In a UCLA study supported by Second Sight, a 30-year-old individual implanted with a wireless, multichannel neurostimulation system on the visual cortex was able to perceive and localize individual phosphenes, or spots of light, with no significant adverse side effects. This implant was performed as part of a proof-of-concept clinical trial with a goal of demonstrating initial safety and feasibility of human visual cortex stimulation. The initial success of the study and pre-clinical work will prepare Second Sight to submit an application to the FDA in early 2017 to gain approval for an initial clinical trial of the complete Orion I system, including camera and glasses. Read more.
- Sixty Percent of Americans with Diabetes Skip Annual Eye Exams
People with diabetes are at increased risk of developing serious eye diseases, yet most do not have annual eye exams, according to a large study presented at the American Academy of Ophthalmology annual meeting in Chicago. Researchers at Wills Eye Hospital found that more than half of individuals with the disease skip these exams. They also discovered that patients who smoke, and those with less severe diabetes and no eye problems were most likely to neglect the exams. Researchers collaborated with the Centers for Disease Control and Prevention to review the charts of nearly 2,000 individuals ages 40 or older with type 1 and type 2 diabetes. Read more.
- PanOptica Reports Positive Results from Phase I/II Clinical Trial
PanOptica reported positive data from a Phase I/II study of PAN-90806, a topical anti-vascular endothelial growth factor eye drop in development for the treatment of neovascular eye diseases. Based on these results, the company plans to initiate a Phase I/II clinical trial in 2017 of a next-generation formulation of topical PAN-90806 in individuals with neovascular age-related macular degeneration. Scott W. Cousins, MD, Robert Machemer professor of ophthalmology and immunology, vice chair for research, and director of the Duke Center for Macular Diseases, presented data on behalf of investigators from the Phase I/II study in 50 treatment-naïve individuals with wet AMD that received topical PAN-90806, during the 2016 Retina Subspecialty Day at the American Academy of Ophthalmology annual meeting in Chicago. An independent panel of retina experts including Dr. Cousins confirmed positive biological response to topical PAN-90806 in approximately 45 percent to 50 percent of treated individuals. Read more.
- Trailblazers in Eye Care Honored at AAO 2016
Influential leaders in eye care were honored at the American Academy of Ophthalmology's Academy's annual meeting in Chicago. The prestigious Laureate Recognition Award, which recognizes ophthalmologists who make exceptional scientific contributions to preventing blindness and restoring sight worldwide, went to Matthew D. Davis, MD, for his groundbreaking work in the study of retinal diseases. Dr. Davis chaired the first clinical trials in the 1970s that showed effectiveness of scatter laser photocoagulation and vitrectomy surgery for diabetic retinopathy. These trials created standard-of-care treatments still being used and models of clinical research for treating the disease. Dr. Davis also established the center that developed photographic standards and systems for analyzing photographs of the retina and assessing changes over time. He was also involved in the development of classifications for diabetic retinopathy and scales for age-related macular degeneration. Read more.