Industry News
Coburn Introduces New HFC-1 Fundus Camera
Coburn Technologies introduced the HFC-1 Non-Mydriatic Fundus Camera, a new retinal camera manufactured by Huvitz, which the company says uses autodetection technology to produce sharp, quick and reliable images and measurements. Automated tracking and shooting allow the HFC-1 Fundus Camera to adjust modes on its own while measuring differing pupil sizes. Its 20-megapixel high-definition camera captures images with reduced motion artifacts and has the capability to enlarge images to study fine details, Coburn says. Users can measure, analyze, diagnose and produce reports using the camera’s built-in PC's 12.1” LCD touchscreen. Read more.
Genetic Test Helps Determine Patient’s Risk of Keratoconus and Presence of Other Corneal Dystrophies
Avellino Lab announced U.S. availability of AvaGen, The Genetic Eye Test, a test that “helps determine a patient’s risk of keratoconus and the presence of other corneal dystrophies.” The company says the test is designed to provide keratoconus patients with an earlier benefit from FDA-approved cross-linking treatment, which can halt disease progression and preserve vision. The AvaGen results can also influence the choice of refractive surgery options for patients, Avellino says. Read more.
GenSight Biologics Case Report Shows Visual Recovery after GS030 Treatment
GenSight Biologics announced the first case report of partial recovery of visual function in a blind patient with late stage retinitis pigmentosa. The subject is a participant in the ongoing PIONEER Phase I/II clinical trial of GenSight Biologics’ GS030 optogenetic therapy. GenSights says the paper in the May issue of Nature Medicine is the first peer-reviewed documentation of visual recovery for a blind patient treated with optogenetic therapy. Read more.
EyePoint Completes Enrollment of Phase I DAVIO Clinical Trial
EyePoint Pharmaceuticals completed patient enrollment of its Phase I clinical trial of EYP-1901 as a potential twice-yearly sustained delivery anti-VEGF treatment targeting wet age-related macular degeneration. EYP-1901 is delivered via an intravitreal injection in the physician's office. The open-label 12-month dose escalation trial is examining wet AMD patients who were responsive to previous anti-VEGF therapies. Read more.
Novartis to Terminate Several Beovu Studies Due to Safety Issues
Novartis reported that it’s terminating its Phase III MERLIN study assessing the efficacy and safety of Beovu (brolucizumab) 6 mg vs. aflibercept 2 mg given every four weeks following the loading phase in patients with wet AMD who have persistent retinal fluid despite anti-VEGF therapy due to higher rates of intraocular inflammation in the Beovu patients.
When given every four weeks in MERLIN, the rate of intraocular inflammation, including retinal vasculitis and retinal vascular occlusion, was 9.3 percent with Beovu, versus 4.5 percent for aflibercept. The incidence of RV and RO for Beovu patients was 0.8 percent and 2 percent, respectively, versus no cases of either form of inflammation with aflibercept. The overall rate of vision loss (15 letters or more) due to all causes was 4.8 percent in the Beovu arm vs. 1.7 percent in the aflibercept arm. In terms of efficacy, the company says that Beovu met MERLIN’s primary endpoint of non-inferiority in change in best-corrected visual acuity from baseline and superiority on select anatomical secondary endpoints at year one vs. aflibercept.
As a result of these adverse events, Novartis also stopped all of its other ongoing brolucizumab clinical programs assessing studies with four-week dosing intervals after the loading phase, stating, “Novartis has decided to terminate the MERLIN study and the RAPTOR and RAVEN studies, which were assessing the efficacy and safety of brolucizumab with six initial monthly injections in retinal vein occlusion. All other relevant ongoing trial protocols will be amended to discontinue four week dosing intervals after the loading phase. Clinical trial investigators have been informed and will appropriately follow-up with their patients. Physicians should not treat patients with Beovu 6 mg at intervals less than two months beyond the first three doses.” Read more.
New Data on Nanoscope's Optogenetic Gene Therapy
Nanoscope Therapeutics announced that vision improvements for all evaluated advanced retinitis pigmentosa patients persisted through one year following a single intravitreal injection in a Phase I/IIa clinical study with MCO. Nanoscope's RP gene therapy, which has received orphan drug designation from the FDA, uses a proprietary AAV2 vector to deliver the MCO genes into the retina. This mutation-independent gene therapy involves a single ocular injection administered in a doctor's office. Read more.
Johnson & Johnson Vision Expands "Sight For Kids" Program and Unveils New “Vision for Good” Community Impact Report
Johnson & Johnson Vision announced the expansion of nonprofit program Sight For Kids. Co-founded in 2002, the program is a collaboration between the company and Lions Clubs International Foundation to “close the gap in access to eye health for children in low income and underserved communities.” Learn more.
Eyenovia Announces Topline Results from VISION-1
Eyenovia announced that its VISION-1 study evaluating the company’s proprietary pilocarpine formulation, MicroLine, for the temporary improvement of near vision in adults with presbyopia, achieved its primary endpoint. The study is required for FDA approval and will serve as the basis for a planned New Drug Application submission. The VISION-1 study evaluated the safety and efficacy of Eyenovia’s 1% and 2% pilocarpine Micro-Array Print formulations vs. placebo, administered via the company’s proprietary Optejet dispenser. Read more.
Prevent Blindness to Host 10th Annual Focus on Eye Health National Summit Virtually
Prevent Blindness will host the 10th annual Prevent Blindness Focus on Eye Health National Summit virtually July 14 to 15. This year’s Summit will include a variety of presentations related to the theme “Our Changing Vision.” During the event, Prevent Blindness will formally present the 2021 Jenny Pomeroy Award for Excellence in Vision and Public Health to R.V. Paul Chan, MD, MSc, MBA, FACS, professor and head of the Department of Ophthalmology and Visual Sciences at the Illinois Eye and Ear Infirmary, University of Illinois at Chicago. Learn more.
B+L & Prevent Blindness Raising Awareness About Cataracts
Bausch + Lomb and Prevent Blindness joined forces for Cataract Awareness Month in June to educate the public and raise awareness about cataracts and cataract surgery. Visit Bausch + Lomb’s Facebook page.
New Amblyopia Treatment in Development
Luminopia One is working on a therapy for amblyopia for kids that uses a virtual reality headset. The treatment involves watching one hour per day of “therapeutically-modified” content that includes popular, mainstream kids’ programming. The therapy is under review with the FDA. Read about some of the findings here and here. Learn more.