Gemini Receives FDA Fast Track Designation for GEM103
Gemini Therapeutics announced that GEM103, the company’s investigational treatment for dry age-related macular generation, was granted FDA Fast Track designation. Gemini is evaluating GEM103, a recombinant, human complement factor H. The company’s Phase IIa ReGAtta study is evaluating GEM103 in patients with geographic atrophy secondary to dry AMD.
Genentech’s Faricimab Meets Primary Endpoint Across Two Phase III DME Trials
Genentech announced positive topline results from two identically designed global Phase III studies, YOSEMITE and RHINE, evaluating the investigational bispecific antibody faricimab in people with diabetic macular edema. Both studies met their primary endpoints and showed that faricimab given every eight weeks and at personalized dosing intervals of up to 16 weeks demonstrated noninferior visual acuity gains compared with aflibercept given every eight weeks. Faricimab was generally well-tolerated with no new safety signals identified. In addition, the Phase III Rhone-X study is investigating the long-term safety and tolerability of faricimab for the treatment of DME. Read more.
Kala Pharmaceuticals Announces Availability of Eysuvis
Kala says its dry-eye drug Eysuvis is now available in national and regional U.S. pharmaceutical distribution centers. Patients with a prescription can acquire it through their local retail pharmacies or through home delivery. Eysuvis is approved for the short-term (up to two weeks) relief of the signs and symptoms of dry eye. Read more.
AsclepiX Doses First Patient in Phase I/IIa Trial of AXT107
AsclepiX Therapeutics announced the first patient was dosed in the Phase I/IIa CONGO clinical trial to evaluate the safety and bioactivity of AXT107 in patients with diabetic macular edema. In December 2020, the FDA cleared the Investigational New Drug application for AXT107 for the treatment of retinal diseases including DME, neovascular age-related macular degeneration and macular edema following retinal vein occlusion. AXT107 is an investigational drug candidate that inhibits VEGF-A and VEGF-C, and activates Tie2. Read more.
Ocular Therapeutix Announces Supplemental NDA for Dextenza
Ocular Therapeutix announced submission to the FDA of a supplemental New Drug Application for Dextenza (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use. If approved, the sNDA would include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication. Read more.
Heru Completes FDA Registration
Heru, a Bascom Palmer Eye Institute medical technology company developing a next-generation AI platform for vision diagnostics and augmentation, announced its class I listing with the FDA for its cloud-based virtual reality platform’s first diagnostic application for visual field exams. Heru’s platform is designed to autonomously diagnose vision defects and customize individual vision augmentation based on the user’s unique vision defects. Read more.
Volk Releases ClearPod to Solve Mask-related Fogging
Volk Optical released its newest product, the ClearPod, to solve the problem of mask-related fogging during fundus exams. This patent-pending design was created in collaboration with Bradley Sacher, MD, a cataract specialist and Jeremy Wingard, MD, a glaucoma specialist at Wheaton Eye Clinic. When a patient breathes naturally while wearing a mask, air escapes through the gaps in the mask and accumulates on the lens surface causing condensation and obstructing views of the retina and slowing down the exam. The ClearPod clips securely onto the Volk fundus lens and form a barrier, directing air currents away from the lens surface. Learn more. Learn more.
Prevent Blindness Calls for Nominations
Prevent Blindness is calling for nominations for the 2021 Jenny Pomeroy Award for Excellence in Vision and Public Health, and the second annual Rising Visionary Award. The deadline for submissions for both awards is February 5. Learn More.
New Hi-Health Division Streamlines Product Ordering Using EHR
Hi-Health says its new eye-care division will help streamline product ordering on electronic health records systems. The company’s Vista line of products will be available to select on the EHR, similar to the way prescriptions are filled out. Eye-care professionals search for the Vista brand, select Hi-Health’s Pharmacy and input orders. Initial product offerings include artificial tears and tea tree oil-based lid cleansing products, along with a family of advanced macular and dry-eye supplements. The company says it chose its unique business model after hearing complaints from doctors that patients’ retail purchases weren’t consistent with their recommended treatments. Learn more about the company.