Eyenovia Earnings Call Provides Drug Updates
■ Eyenovia announced its second quarter earnings for 2023 in a conference call on August 13, also providing an update on its proprietary MicroLine pilocarpine spray formulation for presbyopia. The company said the formulation’s new intended brand-name for the formulation is Apersure, and stated that their research suggests this could be a nearly $1 billion annual market in the U.S. alone. Production of Apersure will begin in the fourth quarter of this year, with the New York-based Eyenovia intending to file a New Drug Application with the FDA late next year.
Describing the testing process for Apersure, Michael Rowe, Eyenovia’s CEO, spoke about how Apersure could substitute for the wearing of glasses when desired. “We tested this concept with 100 optometrists,” Rowe said, “who found that Apersure would meet the needs of both themselves and their patients better than any other pharmaceutical option that they have or believe will have available. These doctors estimated that Apersure ophthalmic spray could capture as much as one-third of the presbyopia pharmaceutical market.”
The company also updated callers on its licensing arrangements. “To date,” said John Gandolfo, Eyenovia’s CFO and secretary, “our license agreements have generated approximately $16 million in license fees with the potential to earn an additional $60 million in net license and development milestones as well as reimbursable expenses over the next 4 years.”
Since the August 13 call, the company has also announced its acquisition of U.S. rights for APP13007, a drug for postoperative ocular inflammation and pain, from Formosa Pharmaceuticals in Taiwan. APP13007 is currently under FDA review.
B+L Launches New Multifocal Contact Lens
■ Bausch + Lomb announced in June the launch of its Infuse multifocal silicone hydrogel daily disposable contact lens. Aiming to address an unmet need among patients with presbyopia, the lens offers 3 zones of vision in a progressive design for near, intermediate, and distance vision.
“With the prevalence of presbyopia estimated to be nearly 80% by age 45-55 in North America,” said Yang Yang, senior vice president of vision care at Bausch + Lomb, in a press release, “we are proud to use our latest science and contact lens technologies to provide eye care professionals and their patients with this new innovative multifocal lens option.”
In addition to its 3-zone design, the Infuse lens’s silicone hydrogel composition is claimed to allow the lens to maintain 96% of its moisture over 16 hours. The lens was developed using B+L’s trademarked ProBalance technology, which the company says helps to maintain ocular surface homeostasis and minimize lens dryness.
A 3-week study that B+L conducted among nearly 300 subjects using the Infuse lens found that 90% of subjects agreed that the lens helped them “effortlessly move from various tasks throughout the day,” and 99% of lens wearers had easy fitting procedures.
Finally, the press release from B+L reminded readers of its ongoing One by One recycling program. More information about the program can be found at www.bauschrecycles.com .
Atia’s OmniVu Reports Positive Data
■ Atia Vision, a medical device company based in Campbell, CA, recently announced the first clinical data on its OmniVu IOL System. The OmniVu IOL, which Atia developed primarily for cataract patients, consists of a shape-changing, fluid-filled accommodating base and a fixed power front optic. The base provides clear vision from far to near, while the front optic is set by the healthcare provider at the patient’s target refraction. The IOL is implanted with the base first via a 55-mm capsulotomy into the capsular bag, followed by installation of the front optic.
George O. Waring IV, MD, founder and medical director of the Waring Vision Institute in South Carolina, presented the results, which included mean monocular BCDVA of 20/19, DCIVA of 20/20, DCNVA of 20/33, and stable refraction within ±0.5 D in 89% of patients implanted with the OmniVu. “There has long been an unmet need for a solution that reliably delivers a full range of vision to patients with cataracts and presbyopia without visual disturbances,” Dr. Waring said in a press release. “I am extremely encouraged by these early findings and look forward to the results of additional studies.”
“We are extremely pleased with these early clinical findings related to the performance of our next-generation lens,” said Mariam Maghribi, Atia’s president and CEO in a press release. “We are excited about the possibilities this innovative technology may offer to eye care professionals and their patients seeking an alternative solution for cataract surgery that facilities a full range of vision.” More about this lens can be found later in this issue.
Nyxol to Get FDA Green Light
■ While announcing last month its earnings for its second quarter ending June 30, Ocuphire also provided updates on its product line, including its Nyxol (phentolamine mesylate 0.75%) eye drop for presbyopia. Nyxol, which Ocuphire is developing in partnership with Viatris, Inc., is currently in phase 3 testing for indications in presbyopia and night-vision disturbances. However, for the initial indication of reversal of drug-induced mydriasis, a date has been set with the FDA under the Prescription Drug User Fee Act (PDUFA) for September 28. Ocuphire expects to report topline results from the phase 3 VEGA-2 Nyxol trial in its fourth quarter.
Ocuphire reports that, at the end of Q2, it has cash or cash equivalents of $40 million, which it believes will be sufficient to continue to fund its operations for another 2 years. The company further reports that it has no debt. Over the first 2 quarters of 2023, the company’s license and collaborations revenues were $3.7 million and $5.4 million for Q1 and Q2, respectively—a massive increase over these quarters last year, when the company reported no such revenues. The company chalks up the revenue to reimbursement for R&D funding for Nyxol.
Ocuphire also has drugs to treat age-related macular degeneration and diabetic retinopathy under development, with additional FDA meetings scheduled later this year to move those drugs further along the pipeline. Assisting in this development will be a newly announced common share purchase agreement with Lincoln Park Capital Fund, a Chicago investment management firm. ■