Presbyopia Physician - November 11, 2022

Newsletter

November 11, 2022

Ocuphire Enters into Global License Agreement for Development and Commercialization of Nyxol Eye Drops

Ocuphire Pharma has concluded an exclusive license agreement with FamyGen Life Sciences for the development and commercialization of Nyxol across three indications (reversal of mydriasis, presbyopia, and night vision disturbances) in the U.S., Europe, Japan, India, China, and other global markets. In connection with its separately announced transaction with Famy, Viatris Inc. has agreed to commercialize Nyxol following each regulatory approval. Under the terms of the license agreement, Ocuphire will receive an upfront cash payment of $35 million. Famy will fund Nyxol development through FDA approvals, that will be managed by Ocuphire, including clinical, manufacturing, and regulatory activities required for FDA approval of all three Nyxol indications, including Nyxol+low-dose pilocarpine. In addition to funding Ocuphire’s development of Nxyol in the U.S., Famy will undertake development in the non-U.S. markets. Upon commercialization, Ocuphire will receive tiered double-digit royalties on worldwide net sales through 2040 and is eligible to receive sales milestone payments upon achievement of certain annual sales thresholds. More information can be found at https://www.globenewswire.com/news-release/2022/11/07/2550236/0/en/Ocuphire-Pharma-Enters-into-a-Global-License-Agreement-for-Development-and-Commercialization-of-Nyxol-Eye-Drops-for-Reversal-of-Mydriasis-Presbyopia-and-Night-Vision-Disturbances.html.

Eyenovia Announces Positive Results from VISION-2 Phase 3 Study of MicroLine for Presbyopia

Eyenovia has announced positive results from its VISION-2 Phase 3 study of MicroLine as a potential topical, on-demand treatment for presbyopia. The VISION-2 study evaluated the safety and efficacy of Eyenovia’s 2% pilocarpine micro-array print (MAP) formulation versus placebo, all administered via the company’s proprietary Optejet device. VISION-2 is the fourth Phase 3 study demonstrating the utility of the company’s MAP technology in improving the therapeutic index of topical ophthalmic drugs. According to a press release, the study showed that in a modified per-protocol analysis of evaluable patients, excluding a non-study related adverse event impacting pupil size and reactivity (new onset anisocoria), VISION-2 met its primary endpoint with a statistically significant proportion of subjects treated with MicroLine showing a 15-letter or more improvement in distance corrected near visual acuity with less than a 5-letter loss in distance acuity versus placebo in low light conditions at two hours post-treatment. The study also achieved all secondary endpoints at a statistically significant level. MicroLine was very well tolerated, with adverse events reported in fewer than 3% of patients, all of which were mild and/or transient. More information can be found at https://www.globenewswire.com/en/news-release/2022/10/20/2538243/0/en/Eyenovia-Announces-Positive-Results-from-VISION-2-Phase-3-Study-of-MicroLine-as-a-Potential-On-Demand-Treatment-for-Presbyopia.html.

LENZ Announces Positive Topline Data from Phase 2 INSIGHT Trial of LNZ100 and LNZ101 for Presbyopia

LENZ Therapeutics has reported positive topline results from its Phase 2 INSIGHT clinical trial of two investigational formulations of aceclidine to treat presbyopia. According to a press release, both LNZ100 (aceclidine), and LNZ101 (aceclidine + brimonidine) achieved the primary endpoint of three-line or greater improvement in near visual acuity, without losing one-line or more in distance visual acuity at one hour, 71% and 56% of treated subjects respectively, compared to 6% of vehicle-treated. The release says both LNZ100 and LNZ101 maintained statistical significance of three-line or greater improvement compared to vehicle for all time points including the last measured at 10 hours, 37% and 48% respectively. Both formulations maintained an average pupil size of 1.5-2mm for 10 hours, which is a biomarker of efficacy. Additionally, patient feedback indicated both formulations were well tolerated and there were no serious drug related adverse events. Based on these positive outcomes, the company plans to initiate Phase 3 trials shortly. More information can be found at https://www.businesswire.com/news/home/20221018005258/en/LENZ-Therapeutics-Announces-Positive-Topline-Data-from-Phase-2-INSIGHT-Trial-of-LNZ100-and-LNZ101-to-Treat-Presbyopia.

Ocuphire Announces Financial Results for Third Quarter and Provides Corporate Update

Ocuphire Pharma has announced financial results for the third quarter ended September 30, and provided a corporate update. According to a press release, the company will initiate the VEGA-2 Phase 3 trial in Q4 2022 investigating Nyxol alone and Nyxol with 0.4% low-dose pilocarpine (LDP) as adjunctive therapy, for treatment of presbyopia patients. In addition, VEGA-3 (2nd Phase 3) and LYRA-1 (1-year safety) trials are planned to begin in 2023. The company plans to submit a New Drug Application (NDA) with the FDA for Nyxol for a reversal of mydriasis indication in Q4 2022, with potential approval and commercial launch as the first dilation reversal drop in 2023. The press release says that as of September 30, 2022, Ocuphire had cash and cash equivalents of approximately $13.9 million. Based on current projections, management believes the current cash on hand will be sufficient to fund operations into the fourth quarter of 2023. Net cash used in operating activities in the third quarter of 2022 was $4.5 million, with a cumulative total for the nine months ended September 30, 2022, of $14.5 million. More information can be found at https://www.globenewswire.com/news-release/2022/11/04/2549078/0/en/Ocuphire-Pharma-Announces-Financial-Results-for-Third-Quarter-2022-and-Provides-Corporate-Update.html.

STAAR Surgical Reports Financial Results for Q3 2022

STAAR Surgical has reported financial results for the third quarter ended September 30, 2022. In a press release, president and CEO Caren Mason said one of the highlights of the quarter was the introduction of the company’s presbyopia lens, EVO Viva, to surgeons at an Experts Meeting preceding the annual congress of the European Society of Cataract and Refractive Surgeons. The press release said the company had net sales of $76.0 million for the third quarter of 2022, up 30% compared to $58.4 million reported in the prior year quarter, and that the sales increase was driven by ICL sales and unit growth of 33% and 40%, respectively, as compared to the prior year period. Gross profit margin for the third quarter of 2022 was 79.5% compared to the prior year quarter of 77.6%, and cash, cash equivalents, and investments available for sale ended the quarter at $224.7 million. More information can be found at https://www.businesswire.com/news/home/20221102005910/en/STAAR-Surgical-Reports-Third-Quarter-Net-Sales-of-76-Million-Up-30-YY.

Novartis Discontinues Development of UNR844 for Presbyopia

Novartis has reported financial results and updates from Q3 2022. The report says the company has decided to discontinue their program with UNR844 for presbyopia, and the Ph2b dose ranging study. The decision was based on the results of an interim analysis of the Ph2b study, evaluating safety and efficacy in patients aged 45-55 years with presbyopia, which did not meet its primary endpoint of demonstrating a statistically significant dose response at Month 3. More information can be found at https://www.novartis.com/news/media-releases/novartis-maintains-growth-momentum-and-confirms-fy22-group-guidance.