Ace Vision Group Expands Advisory Board
• Ace Vision Group, an ophthalmic laser device company headquartered in Boston, announced in early November the appointment of 4 nationally prominent ophthalmologists to its medical advisory board. The four appointees—Cathleen McCabe, MD, of the Eye Associates in Sarasota, FL; James Katz, MD, of the Midwest Center for Sight in Des Plaines, IL; Ehsan Sadri, MD, FACS, FAAO, of the Visionary Eye Institute in Newport Beach, CA; and Dagny Zhu, MD, of NVision Eye Center in Rowland Heights, CA—will contribute to the development of Ace’s VisioLite Ophthalmic Laser System, which helps treat presbyopia by laser scleral microporation, which overcomes ocular rigidity to allow for recovery of dynamic range of focus.
“We are thrilled to welcome Dr. McCabe, Dr. Katz, Dr. Sadri and Dr. Zhu to our medical advisory board,” said AnnMarie Hipsley, DPT, PhD, CEO of Ace Vision Group, in a press release. “Their expertise and dedication to advancing eye care align perfectly with our commitment to creating innovative solutions that address age-related eye conditions. With their valuable insights, we are well-positioned to continue our mission of enhancing quality of life.”
In addition, Ace announced that it named Rob Kissling, MD, as its new chief medical officer. Dr. Kissling comes to this new role after 15 years at Bausch + Lomb, first as a marketing director but eventually as vice president for medical affairs. Dr. Hipsley stated, “Dr. Kissling’s expertise in both the clinical and commercial aspects of ophthalmology product lines make him an ideal addition to our team as we work with leading eye care professionals, building towards the next revolution in eye care.” The 5 new hires expand Ace’s C-suite beyond an expansion undertaken last year.
FDA Approves Orasis’ Presbyopia Drop
• Orasis Pharmaceuticals announced in October the FDA approval of its 0.4% pilocarpine hydrochloride ophthalmic solution (QlosiTM) for the treatment of presbyopia. This approval comes on the heels of the phase 3 NEAR-1 and NEAR-2 trials, both of which met their 8-day primary endpoint of a ≥3-line gain in best distance-corrected visual acuity (BDCVA) at 40 cm and no loss in BDCVA ≥5 letters at 4 m. Headache and instillation site pain were the most common side effects but were mild and occurred in <7% of the more than 600 patients enrolled in the 2 trials. Only 1.3% of patients reported moderate side effects, and none were severe.
“Patients experiencing age-related, blurry near vision are in need of flexible treatment options to manage their presbyopia in ways that work for them with fewer tradeoffs,” said Paul Karpecki, OD, FAAO, of the Kentucky Eye Institute and associate professor at the Kentucky College of Optometry in a press release. “In clinical trials, Qlosi demonstrated the optimal balance of efficacy, safety, and tolerability, and the FDA approval marks an exciting next step in being able to provide a new treatment for patients looking for a break from reading glasses or contact lenses.” Orasis plans to bring Qlosi to market in the first half of next year.
Alcon’s EDOF IOL Premieres in the Great White North
• Alcon launched its Clareon Vivity enhanced depth of focus (EDOF) intraocular lens (IOL) in Canada in early November, providing an option for postcataract patients who are seeking better functional near distance, as well as distance vision, from an IOL. The IOL offers EDOF using X-WAVE technology, which stretches and shifts the light going through the lens without splitting it.
“Clareon Vivity is an excellent lens option that can both improve vision, decrease spectacle dependence, and give my patients the freedom to do the activities they love,” said Ike Ahmed, MD, FRCSC, Chief Innovation Officer at Prism Eye Institute in Brampton, Ontario, in a press release. “I’m excited to offer my patients the benefits of Vivity, but now with a glistening-free material for exceptional clarity.”
The Canadian launch of Vivity follows the FDA approval last year for US release of the Clareon series of IOLs, also including Clareon Monofocal and Clareon PanOptix lenses. The IOL is also already available in Australia, New Zealand, and several European countries.
Ocuphire’s Nyxol Passes Next Milestone to Approval
• Ocuphire announced last month that its phase 3 VEGA-2 trial of Nyxol met its primary endpoint. The randomized, controlled study of the Nyxol 0.75% phentolamine solution for presbyopia had as its primary endpoint ≥15 letters of improvement in photopic binocular distance-corrected near visual acuity and <5 letters of loss in photopic binocular best-corrected distance visual acuity.
In a press release, Ocuphire CEO George Magrath, MD, MBA, MS, stated that the company’s partnership with the Canonsburg, PA-based global healthcare company Viatris will continue into the first half of next year to bring Nyxol past the remaining regulatory hurdles and to market in the United States.
This latest good news for Ocuphire comes a couple of months after FDA approval of its Ryzumvi formulation of phentolamine treatment of pharmacologically induced mydriasis produced by certain drugs, for which Viatris made a $10 million milestone payment to Ocuphire. The company is also partnered with Viatris on a Special Protocol Assessment for 0.75% phentolamine to treat night vision disturbances or dim light vision. ■