Industry News
FDA Authorizes New OMNI Study
The FDA has granted an Investigational Device Exemption authorizing Sight Sciences to conduct a clinical study, called PRECISION, to assess the safety and effectiveness of a new, higher volume (21 microliters of viscoelastic fluid dispensed) version of its OMNI device to perform canal viscodilation alone to lower intraocular pressure in adults with primary open-angle glaucoma. Read more.
Regenxbio to Collaborate with AbbVie
Regenxbio announced the closing of its Collaboration and License Agreement with AbbVie to develop and commercialize RGX-314, an investigational gene therapy for the treatment of wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases. Under the terms of the agreement, Regenxbio will receive an upfront payment from AbbVie of $370 million with the potential for Regenxbio to receive up to $1.38 billion in additional development, regulatory and commercial milestones. Read more.
Alcon to Acquire Ivantis and its Hydrus Microstent
Alcon announced its intention to acquire Ivantis, developer and manufacturer of the Hydrus Microstent, a currently approved, minimally-invasive glaucoma surgery device designed to lower intraocular pressure for open-angle glaucoma patients in connection with cataract surgery. Read more.
Ocugen Submits IND Application for Gene Therapy Candidate
Ocugen submitted an Investigational New Drug application with the FDA to initiate a Phase I/II clinical trial of OCU400 (AAV-NR2E3), a modifier gene therapy candidate for the treatment of retinitis pigmentosa resulting from genetic mutations found in NR2E3 and RHO. Read more.
Gyroscope Announces Sanofi Investment of Up to $60 Million
Gyroscope Therapeutics Holdings announced Sanofi committed to invest up to $60 million in equity in the company. Under the terms of the agreement, a Sanofi R&D executive will join the Gyroscope Clinical Advisory Board to advise on matters related to the development of GT005 for geographic atrophy secondary to age-related macular degeneration. Additionally, Gyroscope granted Sanofi an exclusive right of first refusal on certain potential future transactions for GT005 in select regions. Read more.
Ocular Therapeutix Announces CMS Update on Dextenza Reimbursement
Ocular Therapeutix announced the Centers for Medicare and Medicaid Services released its final rules for the Outpatient Prospective Payment System and Medicare Physician Fee Schedule for 2022. The OPPS final rule confirms that Dextenza will continue to be separately paid by Medicare in the hospital outpatient department and ambulatory surgical center (ASC) settings for 2022. Read more.
Unity Announces VA Improvement in Phase I Study
Unity Biotechnology announced positive 24-week data from its Phase I single ascending dose safety study of UBX1325 in patients with advanced disease from diabetic macular edema or wet age-related macular degeneration. The company says that most patients with DME across all doses had rapid improvements in vision, and patients in the higher-dose cohorts showed a mean gain of 9.5 ETDRS letters in best-corrected visual acuity at 24 weeks following a single injection of UBX1325. Read more.
J&J Vision’s AAO Plans
Johnson & Johnson Vision will present a range of company-sponsored studies supporting new innovations in its cataract surgery portfolio, at the American Academy of Ophthalmology annual meeting in New Orleans, November 12 to 15. In addition, new company-sponsored research that looks at the accuracy of an artificial intelligence-derived algorithm to assess the cup-to-disc ratio using only a photo will be presented. The company will also support events throughout the week promoting the importance of diversity in the ophthalmology community. Learn more.
Apellis Announces Presentations of Phase III DERBY and OAKS Data in GA
Apellis Pharmaceuticals announced that data from the Phase III DERBY and OAKS studies will be presented as part of three oral presentations at the American Academy of Ophthalmology meeting. The studies evaluated the efficacy and safety of intravitreal pegcetacoplan, an investigational, targeted C3 therapy, in geographic atrophy secondary to age-related macular degeneration. In the studies, monthly and every-other-month pegcetacoplan showed a clinically meaningful reduction of GA lesion growth with a favorable safety profile in a broad population, the company says. Read more.
Prevent Blindness Declares Second Annual TED Awareness Week
Prevent Blindness announced that November 14 to 20 will be the second annual “Thyroid Eye Disease Awareness Week.” The newest episode in the Focus on Eye Health Expert Series, “Thyroid Eye Disease,” will feature Sara Wester, MD, associate professor of clinical ophthalmology, Bascom Palmer Eye Institute, TED specialist and oculoplastic surgeon. Learn more.