Visus Therapeutics Initiates Phase 3 Pivotal Trials of BRIMOCHOL PF for the Treatment of Presbyopia
Visus Therapeutics has announced the launch of the first of two pivotal Phase 3 trials (BRIO-I and BRIO-II) for its lead asset, BRIMOCHOL PF, a preservative-free topical ophthalmic solution for the treatment of presbyopia. The initiation of the BRIO trials follows compelling topline data from the company’s Phase 2 VIVID clinical study, which demonstrated two preservative-free formulations, BRIMOCHOL PF and Carbachol PF, were well tolerated and met clinical outcomes to support advancement into pivotal trials. Following encouraging results from the recently completed Phase 2 trial, the company seeks to demonstrate that BRIMOCHOL PF, a proprietary, preservative-free, fixed-dose combination of carbachol (a cholinergic miotic agent) and brimonidine tartrate (an alpha-2 agonist), is a safe and effective once-daily eye drop to correct the loss of near vision associated with presbyopia. The primary efficacy endpoint is the percentage of patients who gain three lines of improvement in binocular near visual acuity without losing one line of distance vision. The first read out of this study is anticipated in Q4 2022. More information can be found at https://www.biospace.com/article/ releases/visus-therapeutics-initiates-phase-3-pivotal-trials-of-brimochol-pf-for-the-treatment-of-presbyopia/.
Allergan Announces Positive Topline Phase 3 Results of Twice-daily VUITY for Presbyopia
Allergan has announced that the Phase 3 VIRGO trial evaluating the safety and efficacy of investigational twice-daily administration of VUITY (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia met its primary efficacy endpoint, improving near vision without compromising distance vision at Hour 9 (3 hours after the second drop) on Day 14. Additional details of this trial will be presented at future medical congresses and will serve as the basis for a supplemental New Drug Application submission for an optional twice-daily administration to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022. The safety profile was similar to that observed in studies with once-daily administration of VUITY; the most common adverse events occurring at a frequency of >5% were headache and eye irritation. The twice-daily use of VUITY is not approved, and its safety and efficacy have not been evaluated by the FDA. More information can be found at https://news.abbvie.com/article_display.cfm?article_id=12425.
Orasis Pharmaceuticals Concludes Phase 3 Clinical Trials for Presbyopia Candidate
Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on developing a unique eye drop for treatment of presbyopia, has completed its NEAR-1 and NEAR-2 Phase 3 clinical studies. CEO Elad Kedar said, “Completion of this clinical trial milestone is exciting because it puts Orasis in position to be next in market. We look forward to sharing topline results in the coming months and advancing CSF-1 toward commercialization.” More information can be found at https://www.orasis-pharma.com/orasis-pharmaceuticals-concludes-phase-3-clinical-trials-for-presbyopia-candidate/.
PanOptix Trifocal IOL Surpasses One Million Implants Worldwide
Alcon has announced that the AcrySof IQ PanOptix trifocal intraocular lens (IOL) has surpassed more than one million implants worldwide. To mark this milestone, Alcon is launching a new “One Million Moments – Thank You” ad campaign that recognizes the positive impact eye care professionals (ECPs) have made on their patients who have been implanted with PanOptix. The campaign will show “thank you moments” between a patient and ECP. The PanOptix lens was recently recognized with Alcon receiving the “Best Medical Technology” award for the 50th Prix Galien USA and previously won the “Business Intelligence Group (BIG) Innovation” award. The PanOptix IOL utilizes advanced ENLIGHTEN optical technology, a proprietary design that optimizes intermediate vision without compromising exceptional near and distance vision. The company says this allows people to see better in both bright and dim conditions by providing a meaningful high total light utilization. More information can be found at https://www.alcon.com/media-release/panoptix-trifocal-iol-surpasses-one-million-implants-worldwide.
Eyenovia Reports Fourth Quarter and Full Year 2021 Financial Results
Eyenovia has announced its financial results for the fourth quarter ended December 31, 2021. Net income for the quarter was approximately $3.0 million, or $0.11 per share ($0.10 per share on a diluted basis), compared to a net loss of approximately $4.2 million, or $0.17 per share in the fourth quarter of 2020. For the full year ended December 31, 2021, net loss was approximately $12.8 million, or $0.49 per share. This compares to a net loss of approximately $19.8 million, or $0.94 per share for the full year 2020. Total license revenue was approximately $10.0 million for the fourth quarter and approximately $14.0 million for the full year 2021 as compared to $2.0 million for the fourth quarter and full year 2020. As of December 31, 2021, the company’s cash and cash equivalents were approximately $27.3 million, including $7.9 million of restricted cash, compared to $28.4 million as of December 31, 2020. More information can be found at https://www.globenewswire.com/news-release/2022/03/28/2411374/0/en/Eyenovia-Reports-Fourth-Quarter-and-Full-Year-2021-Financial-Results.html.
Ocuphire Announces Financial Results for Fourth Quarter and Full Year 2021
Ocuphire Pharma has announced financial results for the fourth quarter and year ended December 31, 2021. As of December 31, the company had cash and cash equivalents of approximately $24.5 million. Based on current projections, management believes the current cash on hand will be sufficient to fund operations into the second quarter of 2023. Net cash used in operating activities for the quarter and year ended December 31, 2021 was $5.6 million and $19.4 million, respectively. No collaboration revenue was recorded in the fourth quarter. Collaborative revenue was $0.6 million for the year ended December 31, 2021. Revenue was derived from the collaboration and license agreements with Processa and Biosense related to certain Rexhan products and technology transfers. There was no collaboration revenue recognized during the comparable prior year periods. Net loss for the quarter ended December 31, 2021 was $6.3 million, compared to $18.7 million for the quarter ended December 31, 2020. Net loss for the year ended December 31, 2021 was $56.7 million, compared to $24.6 million for the year ended December 31, 2020. More information can be found at https://www.ocuphire.com/news-media/press-releases/detail/366/ocuphire-announces-financial-results-for-the-fourth-quarter.