Presbyopia Physician - April 28, 2023

Newsletter

April 28, 2023

Ocuphire Appoints Interim CEO

Ocuphire Pharma has appointed Rick Rodgers as interim chief executive officer and president. Mr. Rodgers is succeeding Mina Sooch. A press release says Ocuphire has retained an executive search firm to assist in identifying a permanent CEO. According to the release, Mr. Rodgers is a seasoned operating executive with 20 years of experience in biopharmaceutical management. He has served on the Ocuphire board as Chair of the Audit Committee and member of the Compensation Committee since the merger with Rexahn Pharmaceuticals Inc. in 2020. From 2010 to 2013, he was co-founder, executive vice president, chief financial officer, secretary, and treasurer of TESARO, Inc., a biopharmaceutical company that was acquired in December 2018 by GSK. From 2009 to 2010, Mr. Rodgers served as the chief financial officer & senior vice president of Abraxis BioScience, Inc., a biotechnology company that was acquired by Celgene. From 2004 to 2008, Mr. Rodgers served as senior vice president, controller and chief accounting officer of MGI PHARMA, Inc., a biopharmaceutical company that was acquired in January 2008 by Eisai. More information can be found at https://www.ocuphire.com/news-media/press-releases/detail/400/ocuphire-appoints-rick-rodgers-as-interim-chief-executive.

FDA Approves Twice-Daily Dosing of Vuity

The FDA has approved a twice-daily dosing option of VUITY (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia. A second dose (one additional drop in each eye) may be administered 3 to 6 hours after the first dose. According to a statement from AbbVie, the duration of effect of VUITY may be extended for up to 9 hours with the approval of twice-daily dosing. This approval is based on results from the double-masked Phase 3 VIRGO trial. The primary endpoint of VIRGO—the proportion of participants gaining three lines or more in mesopic, high contrast, binocular Distance Corrected Near Visual Acuity with no more than 5-letter loss in low light Corrected Distance Visual Acuity at Day 14, Hour 9 (3 hours after the second drop) versus placebo—was met. The most common adverse reactions reported in >5% of participants were headache and eye irritation. Ocular adverse reactions reported in 1-5% of participants were visual impairment, eye pain, blurred vision, and vitreous floaters. Full prescribing information can be found at http://www.vuity.com.

Visus Announces Positive Topline Data from Phase 3 Pivotal BRIO-I Trial of BRIMOCHOL PF for Presbyopia

Visus Therapeutics has reported positive topline results from its Phase 3 pivotal BRIO-I trial. According to a press release, BRIO-I met the pre-specified primary study endpoints agreed upon with the U.S. FDA and the EMA/MHRA, demonstrating contribution of elements for the once-daily, fixed-dose combination, BRIMOCHOL PF, over both active comparators carbachol and brimonidine monotherapies. The release says BRIMOCHOL PF demonstrated highly statistically significant improvements in near and distance binocular visual acuity at multiple timepoints over carbachol and brimonidine, and clinically and statistically significant reductions in pupil size were also observed out to 10 hours. BRIMOCHOL PF was well tolerated with no treatment related serious adverse events. Further details will be presented at upcoming meetings, including the Eyecelerator meeting in San Diego, CA. More information can be found at https://www.businesswire.com/news/home/20230419006081/en/Visus-Therapeutics-Announces-Positive-Topline-Clinical-Data-from-Phase-3-Pivotal-BRIO-I-Trial-of-BRIMOCHOL-PF%E2%84%A2-for-the-Treatment-of-Presbyopia.

LENZ Announces $83.5 Million Series B Financing to Advance its Presbyopia Treatments

LENZ Therapeutics has raised $83.5 million in an oversubscribed Series B financing. According to a press release, new investor Sectoral Asset Management led the financing and was joined by Alpha Wave Ventures and Point 72, as well as existing investors RA Capital Management, Versant Ventures, RTW Investments, and others. In conjunction with the financing, Stefan Larson, PhD, Partner at Sectoral Asset Management, and Chris Dimitropoulos, Managing Director, Alpha Wave Global, joined the LENZ board of directors. In the release, LENZ also announced that it has started its Phase 3 CLARITY program in December 2022. The CLARITY trials, I, II, and III, are double-masked, randomized, U.S.-based, multi-center, safety and/or efficacy trials enrolling a broad population of patients suffering from loss of near vision associated with presbyopia. LENZ is running the three trials in parallel and aims to demonstrate that its product candidates LNZ100 and LNZ101 are both safe and effective once-daily eye drops to correct vision loss. The primary efficacy endpoint is the percentage of patients who gain three lines of improvement in near visual acuity without losing one line of distance vision. More information can be found at https://www.businesswire.com/news/home/20230307005527/en/LENZ-Therapeutics-Announces-83.5-Million-Series-B-Financing-to-Advance-its-Presbyopia-Treatments-LNZ100-and-LNZ101-and-Provides-Update-on-Ongoing-Phase-3-Studies.

BioAdaptives Signs License for Eye Health due to Myopia and Presbyopia

BioAdaptives has announced the signing of a second non-exclusive license agreement with LY Research Corporation to market a patented product (Patent No. US 9,622,970 B2) for eye health due to myopia and presbyopia. A press release explains this patent is a liposome and sustained release polymeric micelles preparation that improves the solubility of lutein. The patent is valued at $570,000,000 by Grant Thornton. BioAdaptives CEO Edward Jacobs, MD, said in the release, “We are very excited to be working on a second product with Dr. Yaguang Liu, LY Research, focusing on eye health due to myopia and presbyopia.” More information can be found at https://www.globenewswire.com/news-release/2023/03/30/2637586/0/en/BioAdaptives-Inc-Announced-Today-the-Signing-of-a-License-for-Eye-Health-due-to-Myopia-and-Presbyopia-a-Patent-Valued-at-US-570-000-000.html.