Topline Data for Lenz Presbyopia Drops Greenlight NDA Submission
• Lenz Therapeutics announced in April topline data from its phase 3 CLARITY trial of its 1.75% aceclidine eye drop (LNZ100) to treat presbyopia. Three key outcomes were demonstrated in the data. Equal percentages of enrollees in the trial achieved at least 3 lines of improvement in best-corrected distance visual acuity at 3 hours, meeting the primary endpoint, and achieved a 3-line improvement at 30 minutes, demonstrating rapid onset. Additionally, 40% of participants retained their 3-line improvements at 10 hours, showing the long duration of aceclidine.
“We believe these data support LNZ100 as a potential best-in-class therapy for the treatment of presbyopia,” said Lenz president and CEO Eef Schimmelpennink in a press release. “The high responder rate, rapid onset and long duration across a broad range of presbyopes ranging from 45 to 75 years of age and having a refractive range from -4.0 to +1.0D SE are consistent with features that patients are expecting from an effective treatment option.”
On the basis of these data, Lenz intends to submit a New Drug Application submission to the FDA by midyear, with hopes for approval by the same time next year.
WCO Releases New Standard of Care
• April was Presbyopia Awareness Month. To mark the month, the World Council of Optometry (WCO) and the Paris- and Milan-based eyewear company EssilorLuxottica collaborated on a new standard of care for presbyopia. They announced the standard’s release on April 29.
The new standard of care is centered around the 3 principles of mitigating, measuring, and managing presbyopia. It also emphasizes the importance of public education and frequent patient discussions so patients know what to expect as they age. “Taking time to address presbyopia by emphasizing to our patients that they have options that suit their lifestyle and needs, while at the same time ensuring proper care for the health of their eyes as they grow older, is a perfect goal for our partnership,” said WCO President Sandra Block, OD, in a press release.
The collaboration between the WCO and EssilorLuxottica dates from 2015, when the two entities first partnered in hosting that year’s World Congress of Optometry. “We look forward to working together with WCO to provide more evidence-based resources through this collaboration,” said Olga Prenat, Head of Medical and Professional Affairs at EssilorLuxottica.
Readers can download the new standard of care at the WCO website: https://worldcouncilofoptometry.info/wp-content/uploads/2024/04/Presbyopia-Standard-of-Care-Resolution.pdf.
New PanOptix Data Presented at ASCRS
• At the annual meeting of the American Society of Cataract and Refractive Surgeons (ASCRS), held in April in Boston, new evidence was presented on Alcon’s PanOptix trifocal intraocular lens (IOL). Sateesh Modi, MD, FRCS(C), presented the findings of a prospective, randomized, double-blind study comparing range of vision and other outcomes reported in patients implanted with the PanOptix in one eye and Johnson & Johnson’s Tecnis Synergy IOL in the other eye. Dr. Modi’s findings were that the PanOptix provided a similar range of vision to the Tecnis Synergy from distance to near (33 cm) under bright and dim conditions with fewer visual disturbances and high patient satisfaction.
In another presentation, Dagny Zhu, MD, reported the results of a meta-analysis and systematic review of visual disturbances after bilateral implantation of PanOptix, with the risks of severe and very bothersome visual disturbances being only ~5% and 3%, respectively.
“All research and advancements we are bringing to ASCRS share one underlining theme: Alcon’s eye care innovations empower surgeons to achieve optimal outcomes for their patients,” said Sergio Duplan, President of North America at Alcon, in a press release. “Not only are we excited to display the unmatched breadth of our eye care innovation portfolio, but perhaps most importantly, to demonstrate the real-life impact these innovations have on the lives of eye care patients around the world.”
Staar Celebrates 3 Million Milestone
• In the lead-up to ASCRS, Staar Surgical, a sponsor of several events at the annual meeting, announced that its 3 millionth EVO implantable contact lens (ICL) had been sold. The EVO ICL, which treats presbyopia, as well as myopia and astigmatism, was approved by the FDA in March 2022, so it has sold approximately 1.5 million units per year since then.
To raise awareness of the ICL, Staar has partnerned with Tennessee Titans quarterback Will Levis, who shared his own experiences as an EVO ICL implantee during a Staar-sponsored event at ASCRS. Paired with this meet and greet was a presentation by Taj Naseer, MD, who presented the outcomes of 229 consecutive implantations of the EVO ICL.
“EVO ICL is the next logical step in refractive innovation,” said Staar CEO and President Tom Frinzi. “While adoption of any new technology takes time, EVO ICL’s adoption rate has been steadily rising since launch—achieving market leadership in key markets—and proving the viability of a global paradigm shift in refractive surgery that both expands the channel, and grows patient adoption within it.
Ocuphire Reports Financials, Updates Investors
• In early May, Ocuphire Pharma announced its final results for its quarter ending March 31. The company reported $47.2 million in cash and cash equivalents, sufficient to fund the company into the first half of next year. Ocuphire also reported licensing and collaborations revenue of $1.7 million for the first quarter, largely derived from its licensing deal with Viatris for its phentolamine ophthalmic solution (Ryzumvi).
“The recent commercial launch of Ryzumvi by our partner Viatris, Inc., was a major milestone,” said George Magrath, MD, MBA, MS, CEO of Ocuphire. “Viatris now has the opportunity to create further value as it pursues additional indications for phentolamine ophthalmic solution, including the treatment of decreased low contrast visual acuity under low light conditions as well as presbyopia.”
Ocuphire also announced 2 new C-suite appointments. Nirav Jhaveri, CFA, MBA, has joined the company as chief financial officer, coming from stints as CFO for other biotech concerns. In addition, Ashwath Jayagopal, PhD, MBA, has joined Ocuphire as chief scientific and development officer, having spent the previous 4 years as vice president and then president of the Association for Ocular Pharmacology and Therapeutics.
