B+L Introduces SimplifEye IOL Delivery System for Envista Toric & Monofocal Preloaded IOLs
Bausch + Lomb introduced the SimplifEye intraocular lens delivery system exclusively for the enVista MX60PL and the enVista toric MX60PT. The system, which the company says is the first preloaded toric IOL available in the United States, is designed to facilitate smooth and consistent implantation of enVista lenses into the capsular bag in three steps through an incision as small as 2.2 mm. The fully enclosed SnapSet cartridge houses an untouched IOL to help ensure proper positioning and reduce the risk of lens damage, while the beveled tip of the system helps enable consistent lens folding, the company says.
Kala Gets FDA Nod for Eysuvis
Kala Pharmaceuticals announced the FDA approval of Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye. Eysuvis uses Kala’s Ampplify mucus-penetrating particle drug delivery technology to enhance penetration of the drug into target tissues on the ocular surface. The FDA granted approval to Eysuvis based on results from four clinical trials. Kala says it plans to launch Eysuvis in the United States by the end of 2020. Read more.
New Norlase Headset Debuts
Norlase recently received 510(k) clearance from the FDA to launch Lion, a green laser photocoagulator that’s fully integrated into a Keeler indirect ophthalmoscope. The company says that, unlike other laser indirect ophthalmoscopes that require a fiber optic connection to a laser source, Lion has no fiber tether, is powered by a battery and uses an advanced wireless interface with optional voice control of laser parameters. Added together, Norlase says that these features result in a lightweight, portable laser treatment solution that can be used in many different settings. Read more.
First Patient Receives Gyroscope’s Investigational Gene Therapy
Gyroscope Therapeutics announced the first patient in its Phase I/II FOCUS trial of its proprietary Orbit Subretinal Delivery System underwent surgery to deliver the company’s investigational gene therapy, GT005, for the treatment of geographic atrophy secondary to dry age-related macular degeneration. Read more.
UCI Study: Restoration of Retinal & Visual Function Post-gene Therapy
In a study at the University of California, Irvine, mice engineered to have inherited retinal disease had their retinal and visual functions restored with a new generation of CRISPR genetic technology. The study, whose findings were published in Nature Biomedical Engineering, applied the new CRISPR approach, called “base editing,” to inherited retinal diseases. Using a Leber’s congenital amaurosis mouse model harboring a clinically relevant pathogenic mutation in the Rpe65 gene, the UCI team successfully demonstrated the therapeutic potential of base editing for the treatment of LCA and potentially other inherited blinding diseases. The treatment also restored retinal and visual function in LCA mice to near-normal levels, the researchers say. Read more.
Nicox Selects NO-mediated, IOP-lowering Agent as Development Candidate
Nicox says it’s selected a new development candidate, NCX 1728, from its proprietary research program focused on nitric oxide-mediated intraocular pressure-lowering agents. The company says an analog of this molecule demonstrated positive results in ocular hypertensive non-human primates compared with travoprost 0.1%, a prostaglandin analog. Read more.
AIVITA’s Stem Cells Found to Help Visual Function in Rats
AIVITA Biomedical announced publication of a study in Investigative Ophthalmology & Visual Science that found retina organoid transplantations with 3D-retina organoids generated from human stem cells demonstrated significant improvement in visual function in RCS rats with retina pigment epithelium dysfunction compared with non-surgery and sham surgery controls. The study was supported by funding from the California Institute for Regenerative Medicine and National Institutes of Health, and led by researchers at AIVITA and the Sue & Bill Gross Stem Cell Research Center of the University of California, Irvine. Read more.
Tarsus Announces IPO
Tarsus Pharmaceuticals announced the closing of its initial public offering of 6,325,000 shares of its common stock at a price to the public of $16.00 per share. All of the shares were offered by Tarsus. The shares began trading on The Nasdaq Global Select Market on October 16, 2020 under the symbol “TARS.” Read more.
Allergan Announces Phase III Topline Results for its Presbyopia Drop
Allergan, an AbbVie company, announced that the Phase III GEMINI I and II clinical trials evaluating the efficacy, safety and tolerability of investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of symptoms associated with presbyopia, met their primary efficacy endpoints. Additional details will serve as the basis for the FDA New Drug Application submission in the first half of 2021. Read more.
Orasis Initiates Phase III Studies of Novel Eye Drop Candidate for Presbyopia Treatment
Orasis Pharmaceuticals announced the initiation of NEAR-1 and NEAR-2 Phase III clinical studies evaluating its eye-drop candidate designed to improve near vision for people with presbyopia. The NEAR-1 and NEAR-2 Phase III studies are multicenter, double-masked, parallel-group clinical trials in the United States enrolling approximately 600 participants. Read more.
Novartis Acquires Vedere Bio, Adding Novel Optogenetic Gene Therapy
Novartis announced it acquired Vedere Bio, adding a new platform for adeno-associated virus (AAV)-based delivery of gene therapies and an optogenetics program for the treatment and prevention of vision loss. The technologies acquired include light-sensing proteins that can be delivered to cells in the retina and unique, AAV delivery vectors that enable treatment via intravitreal injection. Read more.
Aerie Initiates Phase IIb Trial of AR-15512 for DED Treatment
Aerie Pharmaceuticals announced the start of COMET-1, a Phase IIb clinical trial of AR-15512 (TRPM8 agonist) ophthalmic solution for the treatment of patients with dry eye. Topline results from COMET-1 are expected in the third quarter of 2021. Read more.