Topical Immunomodulator Approved for Vernal Keratoconjunctivitis
Santen says its new therapeutic for vernal keratoconjunctivitis, Verkazia, is a cyclosporine 0.1% emulsion that blocks release of pro-inflammatory cytokines, thereby suppressing the immune system and reducing inflammation. In clinical trials, Santen says Verkazia demonstrated improvements in corneal inflammation (keratitis score) and ocular itching. The company also noted that the most common side effects, typically occurring during instillation, were eye pain (12 percent) and ocular itching (8 percent). Read more.
Zeiss Adds SLT Functionality to Laser
Zeiss recently added a selective laser trabeculoplasty module to its Visulas Green Laser. In addition to perfoming SLT, the company says the laser incorporates the company’s “InsightView” display and “TouchControl” center switch to allow physicians to keep their eyes on the patient while changing parameters during laser therapy. Learn more.
Tarsus Announces Topline Data from Saturn-2 Phase III
Tarsus Pharmaceuticals says that TP-03 (lotilaner ophthalmic solution, 0.25%) met the primary endpoint and all secondary endpoints in the company’s Saturn-2 Phase III trial with a favorable safety profile, demonstrating its ability to resolve Demodex blepharitis cases. With these positive results, Tarsus plans to submit a New Drug Application to the FDA in the second half of 2022. Read more.
Stealth Drug Fails to Meet Primary Endpoints in ReCLAIM-2 Trial
Stealth BioTherapeutics announced that data from its Phase II ReCLAIM-2 trial evaluating elamipretide in patients with geographic atrophy secondary to dry age-related macular degeneration reveal the trial didn’t meet its primary endpoints (mean changes in low-luminance visual acuity and GA). However, it added that a secondary endpoint showed that elamipretide improved visual function for GA patients. Learn more.
Iveric Bio Presents Post Hoc Analysis from GATHER1
Iveric Bio announced a post hoc analysis evaluating the reduction in geographic atrophy lesion growth observed in patients receiving Zimura (avacincaptad pegol) compared to patients receiving sham in the completed GATHER1 clinical trial would be presented at the Retinal World Congress in Fort Lauderdale, Fla. The study analyzes the reduction in GA lesion growth, in a subset of GATHER1 patients, based on the distance of a patient’s GA lesion from the foveal center at baseline. In line with the overall results of GATHER1, a reduction of GA lesion growth in patients receiving Zimura as compared to patients receiving sham was consistently observed across all baseline distances from the foveal center, the company says. Read more.
J&J Vision Appoints Peter Menziuso as Company Group Chairman
Johnson & Johnson Vision announced the appointment of Peter Menziuso as Company Group Chairman to lead the full Johnson & Johnson Vision portfolio. This includes brands such as Acuvue contact lenses, the Tecnis family of intraocular lenses, TearScience LipiFlow and more. Learn more.
The following companies presented these findings at the Association for Research in Vision and Ophthalmology annual meeting, May 1-4, in Denver and virtually.
• Applied Genetic Technologies presented additional findings from the ongoing X-linked retinitis pigmentosa Phase I/II study of AGTC-501, including 18-month safety and efficacy data showing safety and efficacy signals similar to the study’s 12-month findings. Read more.
• Lineage Cell Therapeutics announced that data from the ongoing Phase I/IIa clinical study of RG6501 (OpRegen), a retinal pigment epithelial cell therapy in development to treat geographic atrophy secondary to age-related macular degeneration shows that the treatment has the potential to arrest GA disease progression, particularly when delivered on-target and in earlier disease. Read more.
• Johnson & Johnson Vision presented 26 poster and podium presentations focusing on myopia, cataract, dry eye, vision science and refractive research. Learn more.
• Opthea announced clinical data on the efficacy and safety of OPT-302 in combination with ranibizumab for polypoidal choroidal vasculopathy finding OPT-302 (2.0 mg) used in combination with ranibizumab (0.5 mg) achieved superior visual acuity gains and anatomic improvements compared to monthly ranibizumab monotherapy in these subjects with PCV type CNV. Read more.
• MeiraGTx presented additional clinical data from the Phase I/II trial of botaretigene sparoparvovec for the treatment of X-linked Retinitis Pigmentosa (XLRP). A poster presentation of human retinal organoid vector efficacy data was also presented at the conference, the company says. Read more.
IRIS Registry Sheds Light on Glaucoma Surgery Trends
The 2021 American Academy of Ophthalmology IRIS Registry Report shows a greater than 80-increase in glaucoma surgeries over an eight-year period from 2013 to 2021. According to the report, put out by Verana Health, more than 1 million glaucoma procedures were performed during this time. However, trabeculectomies peaked in 2015 with 14,600 procedures annually, then declined to just 9,300 per year by 2021. Over this same period, there was an increase in implantation of trabecular meshwork bypass stents, the report found. Read more.
Ocuphire Gives Trial Update
Ocuphire Pharma recently announced results from its MIRA-4 pediatric safety trial investigating its product candidate Nyxol for the reversal of pharmacologically-induced mydriasis. The company says the results demonstrated that Nyxol’s efficacy and safety in pediatric subjects 3 to 11 years of age was consistent with that shown in previous studies that enrolled both adolescents (age 12 to 17 years) and adults. Read more.
Samsara to Initiate PMA Supplemental Study of New-generation SING IMT
Samsara Vision announced that it’s initiating a PMA supplemental study to evaluate improvements in visual acuity and the safety of its SING IMT (Smaller-Incision New-Generation Implantable Miniature Telescope) in people living with late-stage AMD. Learn more.