Nevakar announces formation of ophthalmic subsidiary, Vyluma

Nevakar Inc. announced on Tuesday it has formed Vyluma Inc., which will focus on the development and commercialization of therapies to treat ophthalmic diseases.

Vyluma will operate as a wholly owned subsidiary of Nevakar, a privately held biopharmaceutical company based in Bridgewater, NJ, with a portfolio of products in the ophthalmic and injectable areas.

According to the company, Vyluma will focus on ophthalmic pharmaceutical therapies, with an emphasis on refractive errors. The company noted that there currently are no pharmaceutical treatment options approved for refractive errors such as childhood myopia, presbyopia, night vision disturbance, and hyperopia.

Vyluma’s lead product candidate is NVK002, which is in late Phase III clinical development. Readouts are anticipated during the fourth quarter of 2022. 

If approved, NVK002 would be the first pharmaceutical therapy to slow the progression of myopia in children.

Vyluma's pipeline also includes programs for treatment of pediatric myopia, presbyopia, night vision disturbance, acute ocular pain, and hyperopia.

Navneet Puri, PhD, founder, chairman and CEO of Vyluma, pointed out that Nevakar has gained traction in advancing its product pipeline which includes hospital injectable and ophthalmic products.

“After validation of our ophthalmology franchise by establishing key partnerships with Zhaoke in China and Théa in Europe for NVK002, and early strong clinical data on other ophthalmic programs, it was clear we needed to separate the ophthalmic portfolio from our injectable business to bring increased focus to this area of fundamental human need,” Puri said in a statement.

“With the establishment of Vyluma, our ophthalmic portfolio will have a dedicated team of professionals focused on assuring Vyluma meets its commitment to patients, prescribers, shareholders and other key constituents,” Puri added in the statement.

In addition to Puri, Vyluma's leadership team will include Marshall Woodworth, chief financial officer; Raul A. Trillo, Jr., MD, chief commercial officer; and Houman Hemmati MD, PhD, chief medical officer.

Hemmati noted in a statement that the new company has an “opportunity to improve patient care and quality of life developing a pipeline of products focused on the biggest unmet need, myopia, as our leading pipeline candidate, followed by additional indications outside of refractive errors in the cornea and anterior segments.”

The company also noted in the statement that board of directors with a focus on ophthalmology will be appointed. One board member already announced is Tuyen Ong, MD, CEO of Ring Therapeutics and former senior vice president at Biogen, with more than 20 years of clinical and drug development experience in ophthalmology.

Zhaoke Ophthalmology, based in China, and Laboratories Théa, headquartered in Europe, are key commercial partners for Vyluma. Earlier this year, Nevkar entered into a licensing agreement with Théa for the commercialization of NVK-002.

The company further announced it has formed Nevakar Injectables Inc., also a wholly owned subsidiary of the parent company.

The newly formed company has a portfolio of products focused on critical patient care, acute pain management, long acting injectables and hospital infections.