Visus Gets a Step Closer to FDA Approval for Combo Drop

■ At the ASCRS meeting in San Diego in May, Visus Therapeutics presented topline data from its phase 3 BRIO-I trial of Brimochol PF, its preservative-free eyedrop combining carbachol and brimonidine for the treatment of presbyopia. Brimochol PF met its primary and secondary endpoints, clearing a hurdle and moving closer to FDA approval. A related article can be found on page 11 of this issue.

In other news, Visus announced in April that it appointed Jehan Tamboowalla as its new senior vice president of business development and marketing. Referring to Taamboowalla’s “successful record of partnering assets, acquiring novel technologies, and launching ophthalmic medicines,” Visus cofounder and CEO Ben Bergo said in a press release, “We are pleased to welcome Jehan to the Visus leadership team as we approach exciting company milestones.”

Tamboowalla comes to Visus after stints in the pharma space overseeing ophthalmology drug development and marketing at Novartis, GlaxoSmithKline, and Bausch + Lomb, as well as product management and strategic planning at Bayer. “Visus is developing one of the best pipelines in the industry,” Tamboowalla said. “I am thrilled to join Visus at such an exciting time for the company.”

FDA Approves Twice-Daily Vuity for Presbyopia

■ Allergan has obtained FDA approval of a twice-daily dosing option for its Vuity 1.25% pilocarpine eyedrop for presbyopia. The approval comes on the heels of the company’s successful phase 3 VIRGO trial, which randomized 230 participants to receive twice-daily administration of either Vuity or a placebo, with drops given 6 hours apart.

At 14 days, 3 hours after the second drop, 35.1% of enrollees receiving Vuity gained at least 3 lines in mesopic, high-contrast, binocular distance-corrected near visual acuity with no more than a 5-letter loss in low-light, corrected distance visual acuity, compared to 7.8% receiving placebo. The difference was highly statistically significant (P<0.0001). Headache and eye irritation were the most common side effects reported, with blurred vision, vitreous floaters, and other adverse events occurring in less than 5% of treated eyes.

The VIRGO trial results augment findings from the GEMINI-1 and -2 trials, based on which the FDA initially approved Vuity for once-daily dosing in October 2021. With the newly approved dosing regimen, patients experiencing only limited benefit from Vuity may now have improved outcomes. A related article can be found on page 12 of this issue.

Rodgers in as Interim CEO at Ocuphire

■ Ocuphire announced in April that it hired Rick Rodgers as its interim CEO, following the departure of Mina Sooch. Rodgers has served for the last 3 years as a member of Ocuphire’s board as chair of the audit committee and a member of the compensation committee. With Rodgers in the interim position, Ocuphire will continue to conduct a search for a permanent CEO.

“I am honored to serve as Interim Chief Executive Officer of Ocuphire at this critical juncture in the Company’s maturation,” Rodgers said in a press release. "I look forward to working closely with the management team to seamlessly execute our near-term priorities.” Among these priorities is Nyxol, Ocuphire’s preservative-free phentolamine solution under development for reversal of drug-induced mydriasis, presbyopia, and night-vision disturbances. “We are excited to be partnered with Viatris which has selected the Nyxol portfolio of indications as a key element of its plan to create a global eye care leader,” Rodgers added, noting the collaboration with Viatris that began last year.

Cam Gallagher, Ocuphire’s board chair, said, “Rick’s experienced leadership at late-stage biopharmaceutical companies will be invaluable as we execute our strategy.”

Ndume Honored at ASCRS

■ This year’s recipient of the ASCRS Foundation Chang-Crandall Humanitarian Award is Helena Ndume, MD. Dr. Ndume lives and works in Namibia in southwest Africa, where for nearly 3 decades she has volunteered with Surgical Eye Expeditions (SEE) International, a charity that provides manual small-incision cataract surgery to treat vision loss.

“This is an honor that I have not and could not have imagined in my wildest dreams,” Dr. Ndume said in a press release. “I am receiving the honor with an overwhelming sense of joy, but in my heart, I know that this award belongs to all of those who have and continue to make the Namibian Blindness Prevention Project a success.”

The ASCRS award is one of many that Dr. Ndume has won. In 2015, she won the highly prestigious Mandela Award from the United Nations, which the NGO gives for “dedicated service to humanity, in the promotion of reconciliation and social cohesion, and in community development.” Dr. Ndume and SEE International were recently featured in Presbyopia Physician (Goldberg DF. SEEing in Africa. Presbyopia Physician, Volume: 2, Issue: December 2022, page(s): 30-33).

A Good Quarter for Eyenovia

■ In May, Eyenovia reported its first quarter financial results, which were marked by its ending the first quarter of 2023 with approximately $18.5 million in cash on hand. FDA approval of its Mydcombi fixed-dose combination spray of tropicamide and phenylephrine for mydriasis has given the New York-based company access to an additional $5 million of capital from Avenue Capital before the end of July. In addition, Eyenovia’s proprietary MicroLine pilocarpine formulation for presbyopia received positive feedback from the FDA.

“With one product approved, and line-of-sight toward a second, we have reached a true inflection point in the evolution of our company,” said Michael Rowe, Eyenovia’s CEO, in a press release. “Regarding our pre-NDA MicroLine program for presbyopia, we received clear feedback from the FDA that provides an efficient path forward for the program.”

The stock market has reacted positively to Eyenovia’s news, with the company’s stock on the NASDAQ hitting $5.85 on May 3—its biggest high since fall of last year. Overall, the stock is up nearly 100% for this year. “I am pleased with our progress to date,” Rowe said, “and look forward to initial commercial sales of Mydcombi this summer together with continued clinical and regulatory progress for us and our partners.” ■