Alcon Surgical Planning System Debuts
Alcon recently released its Smart Solutions platform, starting with its Smart Cataract System. Using the software, surgeons and their staff can enter data once, and have it carried forward throughout the office, from EHR systems to diagnostic equipment and surgical devices. The application connects data systems and most diagnostic devices, including the Argos Biometer with Image Guidance, with Alcon’s cataract surgical equipment, including the LenSx Femtosecond Laser and LuxOR Revalia Ophthalmic Microscope, as well as commonly used microscopes and devices from other ophthalmic manufacturers. The company says by connecting biometry instruments with other medical records, surgical planning will be expedited. Alcon says entering the data only once will help eliminate transcription errors. SMART Solutions makes use of the open, cloud-based infrastructure and services of Philips HealthSuite, built on Amazon Web Services, to enable surgeons to aggregate, organize and analyze all relevant data within a single, integrated application “designed for security and remote planning.”
Alcon is installing the system in several additional customers in the United States through the end of the year, and plans a broader rollout of Smart Cataract in 2022. Read more.
Apellis Plans to Submit NDA in 2022 for Pegcetacoplan for GA
Apellis Pharmaceuticals received written correspondence from the FDA that reinforces the company’s plans to submit a New Drug Application for intravitreal pegcetacoplan for geographic atrophy secondary to age-related macular degeneration. The NDA will be supported by efficacy and safety data from the Phase III DERBY and OAKS studies and the Phase II FILLY study. In the written feedback, the FDA stated that it doesn’t make a distinction between phases, provided a clinical trial is adequate and well-controlled, and that all three studies appear to be adequate and well-controlled. Based on this feedback, Apellis remains on track to submit an NDA in the first half of 2022. Read more.
Oculis Begins Phase III Study for Topical Eye Drop Treatment for DME
Oculis announced the first patients were dosed in its Phase III DIAMOND trial evaluating the efficacy and safety of OCS-01 in diabetic macular edema. OCS-01 is a novel, high concentration, preservative free, topical formulation of dexamethasone. OCS-01 has been shown to improve visual acuity and reduce central macular thickness in DME patients compared to vehicle and demonstrated a promising safety profile in the 144-patient Phase IIb (DX-211) trial, the company says. Read more.
Outlook Presents NORSE TWO Phase III Safety and Efficacy Data for ONS-5010 / Lytenava (bevacizumab-vikg)
Outlook Therapeutics presented pivotal safety and efficacy data from the Phase III NORSE TWO trial for ONS-5010, an investigational ophthalmic formulation of bevacizumab for use in wet age-related macular degeneration and other retinal indications, at the American Academy of Ophthalmology annual meeting’s Retina Subspecialty Day in New Orleans. The trial met both primary and secondary endpoints, including:
• 41.7 percent (p=0.0052) ONS-5010 subjects gained ≥15 letters of vision;
• 56.5 percent (p=0.0016) ONS-5010 subjects gained ≥10 letters of vision;
• 68.5 percent (p=0.0116) ONS-5010 subjects gained ≥5 letters of vision; and
• ONS-5010 subjects gained 11.2 letters (p=0.0043) in BCVA.
Results also demonstrated that ONS-5010 ophthalmic bevacizumab had a strong safety profile, the company says. Read more.
Ivantis Shares New Hydrus Microstent Data
Ivantis, developer of the Hydrus Microstent, a minimally invasive glaucoma surgery device intended to lower eye pressure for open-angle glaucoma patients, announced new data from its five-year HORIZON pivotal trial showing the Hydrus Microstent lowered the rate of visual field loss by 47 percent vs. cataract surgery alone. The preliminary findings were presented at the AAO annual meeting. Ivantis is to become part of Alcon in the first quarter of 2022. Read more.
EyePoint Reports Interim Data from Phase I DAVIO Trial
EyePoint Pharmaceuticals announced positive six-month interim data from the DAVIO Phase I clinical trial of EYP-1901, a bioerodible sustained delivery intravitreal anti-vascular endothelial growth factor treatment targeting wet age-related macular degeneration, at the AAO annual meeting’s Retina Subspecialty Day. Data uncovered no reports of ocular serious adverse events (SAEs), drug-related systemic SAEs; or AEs such as vitreous floaters, endophthalmitis, retinal detachment, implant migration in the anterior chamber, retinal vasculitis or posterior segment inflammation, the company says. Read more.
Regenxbio Presents Data from RGX-314 Trials in Wet AMD & DR
Regenxbio announced “additional positive interim data” from the ongoing Phase II AAVIATE trial and the ongoing Phase II ALTITUDE trial of RGX-314 using in-office suprachoroidal delivery for the treatment of wet age-related macular degeneration and diabetic retinopathy without center-involved diabetic macular edema, respectively. The results were presented at the AAO annual meeting. As of November 4, RGX-314 was reported to be well-tolerated across 50 patients dosed in cohorts one to three. Four serious adverse events reported in four patients were considered not related to RGX-314. Read more.
jCyte Identifies Biomarker
jCyte says that its Phase IIb study has found that retinitis pigmentosa patients with a baseline central visual field diameter greater than 20 degrees had a profound response to the company’s jCell treatment. Data comparing the response of a single 6 million cell intravitreal injection of jCell vs. sham revealed that RP patients with a central VF diameter >20 degrees had a statistically significant BCVA change from baseline at 12 months of 15.6 letters (p=0.029). Read more.
Bausch + Lomb Recycles
Bausch + Lomb announced its One by One and Biotrue Eye Care Recycling programs have recycled a total of 41,358,603 million units, or 248,516 pounds, of used contact lens, eye- and lens-care materials. The programs are made possible through a collaboration with TerraCycle. Read more.
OcuTerra Raises $35 Million Series B Financing
OcuTerra Therapeutics announced the close of a $35 million Series B financing. Proceeds will support the “DR-EAM” Phase II study of OTT166 in patients with moderate to severe non-proliferative and mild proliferative diabetic retinopathy. Read more.