Phase 3 Results for MicroLine Bring Eyenovia Closer to the Finish Line
• Eyenovia obtained positive results from its phase 3 VISION-2 study of MicroLine, its pilocarpine ophthalmic solution administered in a topical spray form using the company’s Optejet delivery system. The drug, intended for on-demand improvement of near vision in people with presbyopia, resulted in a statistically significant proportion of the 140 enrolled subjects experiencing an improvement in distance-corrected near vision acuity of 15 letters or more while losing fewer than 5 letters in distance vision. The study participants experienced few adverse events (<3% of enrollees).
“We are very pleased with these Phase 3 study results which again demonstrate the benefits of our proprietary Optejet device that underpins MicroLine as a potential on-demand treatment for presbyopia,” stated Michael Rowe, CEO of Eyenovia in a press release. “MicroLine, if approved, would be the only option that is designed to provide the ease-of-use, convenience, and reduced exposure to drug and preservatives that we believe are significant benefits of the Optejet device.”
Eyenovia will follow VISION-2 with a second required phase 3 trial for FDA approval. The company has also developed a treatment for pediatric myopia progression and an agent for pharmacologic mydriasis using Optejet and has signed licensing agreements with companies in China and South Korea.
Ocuphire Inks Global Licensing Agreement
• Ocuphire has concluded a $35 million licensing agreement with FamyGen Life Sciences, Inc., a drug-development company based in Las Vegas, to market its Nyxol 0.75 phentolamine eye drop globally for 3 indications: for the treatment of presbyopia and night vision disturbances, and to reverse pharmacologically induced mydriasis. Among other markets, the agreement will focus on markets in the United States, Europe, Japan, India, and China as the drugs move through the FDA approval process.
Canonsburg, PA-based global healthcare company Viatris, Inc., will commercialize Nyxol once regulatory approval is given. Ocuphire intends to submit a New Drug Application to the FDA in the coming months for Nyxol in the reversal of mydriasis.
“This partnership provides a clear pathway to completing development and regulatory activities and executing a successful US and global commercial launch of Nyxol through Viatris,” said Mina Sooch, MBA, founder, and CEO of Ocuphire in a press release. “With its strategic commitment to ophthalmics and its global commercial infrastructure, we believe Viatris provides a great opportunity for all of the Nyxol indications to realize their full commercial potential in their respective markets.”
Lenz Therapeutics Gains With INSIGHT
• Lenz Therapeutics has gained positive topline data from its phase 2 INSIGHT trial of its compounds LNZ100 and LNZ101. The two eye drops – aceclidine monotherapy or a combination of aceclidine with brimonidine – are both under development for the treatment of presbyopia. The two drugs both demonstrated improvements in near visual acuity of 3 lines or more without losing 1 or more lines in distance visual acuity at 1 hour.
Compared to 6% of control participants, 71% and 56% of participants treated with LNZ100 and LNZ101, respectively, showed optimal responses, with 37% and 48% maintaining these gains out to 10 hours. Pupil size remained diminished to 1.5-2 mm for this duration as well, demonstrating aceclidine’s mechanism of action of narrowing the pupil size to improve visual acuity.
“We know that the majority of presbyopia patients are looking for a product that is highly effective in improving near vision for their full workday,” said Eef Schimmelpennink, president and CEO of Lenz, in a company press release. “Our best-in-class results clearly reflect this ideal profile, with 10-hour efficacy, and further extends our potential for category leadership.” Phase 3 trials will be next for Lenz.
STAAR Surgical Reports Substantial 3Q Growth
• STAAR Surgical issued its third-quarter financial results on November 2, reporting net sales of $76 million – a 30% increase over the prior year quarter. In addition, the company reported sales of its EVO implantable collamer lens (ICL) of $72 million over last year’s figures. The company’s third quarter ended on September 30.
“In the third quarter, global ICL unit growth was up 40% year over year, highlighted by unit growth in China up 52%, the U.S. up 63%, Japan up 40%, South Korea up 49% and Asia Pacific distributor markets up 47%,” said Caren Mason, president and CEO of STAAR Surgical, in a press release. “We advanced our patient awareness, engagement and market building initiatives for EVO in the U.S. during and subsequent to the third quarter.”
These gains come even as the company simultaneously announced that it will no longer be able to support its low-margin business in cataract intraocular lenses (IOLs), IOL injectors, and injector parts, citing supply chain issues. STAAR Surgical will support these products until the end of 2023.
Novartis Drops UNR844 but Raises Revenue
• Novartis announced at the end of October that it is stopping development of UNR844 (lipoic acid/choline ester chloride), its investigational presbyopia compound, after phase 2B study results failed to show a statistically significant dose response after 3 months of treatment. The company had acquired rights to UNR844 as part of its $375 million buyout of Encore Vision 5 years ago. “Interim analysis of the Ph2b dose ranging study evaluating safety and efficacy in patients aged 45-55 years with presbyopia did not meet its primary endpoint of demonstrating a statistically significant dose response at Month 3,” the company stated in its third-quarter report. “Based on these results, Novartis has taken the decision to discontinue the Ph2b study and UNR844 program. In that third quarter report, the company reported $12.54 million in net sales, constituting a 4% increase in constant currency over the previous quarter and resulting in 5% overall growth so far this year. CEO Vas Narasimhan, MD, said, “Looking ahead, we are confident in delivering growth and margin expansion through our new focused ‘pure-play’ Innovative Medicines strategy, underpinned by our five core TAs, technology platforms, priority geographies, and a deep, value-oriented pipeline.” ■