BRIDGEWATER, N.J.—Nevakar Inc., a privately held biopharmaceutical company, announced the establishment of Vyluma Inc., a newly formed company with a focus on the development and commercialization of therapies to treat ophthalmic diseases. At inception, Vyluma will operate as a wholly owned subsidiary of Nevakar Inc. Vyluma will focus on first-in-class and best-in-class ophthalmic pharmaceutical therapies, with an emphasis on refractive errors. Currently, there are no pharmaceutical treatment options approved for refractive errors such as childhood myopia, presbyopia, night vision disturbance, and hyperopia.

NVK002 is Vyluma’s lead product candidate in late Phase III clinical development with readouts anticipated in the fourth quarter of 2022. If approved, it would be the first pharmaceutical therapy to slow the progression of myopia in children, the announcement said.

“Founded on the principle of improving patients’ quality of life and health care outcomes, Nevakar has gained significant traction in advancing its product pipeline which includes hospital injectable and ophthalmic products," said Navneet Puri, PhD, founder, chairman and CEO of Vyluma. “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.

"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.”

In addition to Puri, Vyluma’s leadership consists of Marshall Woodworth, MBA chief financial officer; Raul A. Trillo, Jr., MD, MBA, chief commercial officer; and Houman Hemmati MD, PhD, chief medical officer.

“We have an incredible 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," said Dr. Hemmati.

An ophthalmology-focused board of directors will be appointed, including Tuyen Ong, MD, MBA, CEO of Ring Therapeutics and former senior VP 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. Vyluma’s pipeline includes programs for treatment of pediatric myopia, presbyopia, night vision disturbance, acute ocular pain, and hyperopia.

Nevakar Inc., founded in 2015, is a privately held, late-stage biopharmaceutical company with an extensive portfolio of products in the ophthalmic and injectable areas.