First Subject Dosed in Nevakar’s Phase III Trial of NVK-002 for Myopia in Children

November 24, 2017: By Jon Swedien

Nevakar announced Nov. 21 that the first subject has been dosed in its Phase III clinical trial of NVK-002 for myopia in children.

NVK-002 is a topical ophthalmic solution intended to slow the progression of myopia in children. If it receives US FDA approval, NVK-002 would be the first pharmacologic eye drop for this patient population, Nevakar said.

The Phase III trial will enroll about 500 subjects ages 3 to 17 who have myopia spherical equivalent refraction (SER) of at least -0.50 diopters and no greater than -6.00 diopters in each eye. The three-arm, randomized, multicenter, double-masked, placebo-controlled trial will be conducted in two stages.

The first will evaluate the safety and efficacy of two concentrations (low dose and high dose) of NVK-002 compared with placebo for slowing progression of myopia over a three-year period. The second stage will be a randomized cross-over phase of one year in duration.

Need Deeper Analysis? Sign up for Market Scope's monthly newsletter to get in-depth coverage of the ophthalmic market, including quarterly procedure volumes based on survey data and meeting coverage from around the world.

Recent Ophthalmic News

US FDA Approves Icon Bioscience’s DEXYCU for Post-Cataract Surgery Inflammation

FDA’s Gottlieb Appears to Soften Stance on Compounding for Office Use

Genentech’s RG7716 Outperformed Ranibizumab in Phase II Study in Diabetic Macular Edema

Santen Reports Promising Data in Phase I/II Study in Refractory Wet AMD

Q Biomed Signs Agreement with Washington University for Novel Biomarker for Monitoring Glaucoma

pSivida’s Durasert for Posterior Segment Uveitis Yields Positive 12-Month Results in Second Phase III Study

Foundation Fighting Blindness Provides $7.5 Million to Help Develop ProQR’s Candidate for Usher Syndrome

Presbia Names Casey Lind as Chief Operating Officer, Magda Michna, MD, PhD, as Chief Clinical Officer

Astellas Acquires Universal Cells

Pixium Vision Completes Two Successful PRIMA Implantations in Atrophic Dry AMD Patients

Omeros Loses Pass-through Status for Omidria

USC Donations Drop $100 Million after Puliafito Scandal, Report Says

Regeneron’s US Eylea Sales Increase 14 Percent in Q4-2017

Allergan’s Net Sales Climb 12 Percent in Q4-2017; Restasis Sales Grow Nearly 1 Percent

Lucentis’ US Sales Drop 11 percent in Q4-2017, Grow 1 Percent for Full 2017

EyeGate’s EGP-437 for Post-Cataract Pain, Inflammation Produces Mixed Results in Phase IIb Trial

Second Sight Reports Record Number of Argus II Implants in Q4-2017, First Orion Implant in Human

Allergan Appoints Matthew Walsh as CFO

Ocunova Secures $500 Thousand From Two Firms to Pursue Dry Eye Treatment for Diabetic Patients

ReVision Optics Closes Doors; Raindrop Corneal Inlay No Longer Available

Coming soon

2018 Retinal Surgical Devices Report: A Global Market Analysis for 2017 to 2023