FDA grants IND for dry eye product

Article

Novagali Pharma's Investigational New Drug Application (IND) to conduct a pivotal Phase III clinical trial of its dry eye candidate, Nova22007, has been granted by the FDA.

Novagali Pharma's Investigational New Drug Application (IND) to conduct a pivotal Phase III clinical trial of its dry eye candidate, Nova22007, has been granted by the FDA.

Nova22007 is a cyclosporine A ophthalmic product developed for the treatment of patients with moderate to severe dry eye syndrome. The proprietary cationic emulsion enables penetration of the drug into tissues of the ocular surface.

The planned double-masked, randomized, vehicle-controlled study will evaluate the efficacy of Nova22007 in relieving objective and subjective dry eye symptoms.

Recent Videos
Patrick C. Staropoli, MD, discusses clinical characterisation of Hexokinase 1 (HK1) mutations causing autosomal dominant pericentral retinitis pigmentosa
Richard B. Rosen, MD, discusses his ASRS presentation on illuminating subclinical sickle cell activities using dynamic OCT angiography
ASRS 2024: Socioeconomic barriers and visual outcomes in patients with rhegmatogenous retinal detachments, from Sally S. Ong, MD
Ashkan Abbey, MD, speaks about his presentation on the the CALM registry study, the 36-month outcomes of real world patients receiving fluocinolone acetonide 0.18 mg at the annual ASRS meeting in Stockholm, Sweden.
Nikoloz Labauri, MD, FVRS, speaks at the 2024 ASRS meeting about suspensory macular buckling as a novel technique for addressing myopic traction maculopathy
Jordana Fein, MD, MS, speaks with Modern Retina about the IOP outcomes with aflibercept 8 mg and 2 mg in patients with DME through week 48 of the phase 2/3 PHOTON trial at the annual ASRS meeting in Stockholm, Sweden.
John T. Thompson, MD, discusses his presentation at ASRS, Long-Term Results of Macular Hole Surgery With Long-Acting Gas Tamponade and Internal Limiting Membrane Peeling
ASRS 2024: Michael Singer, MD, shares 100-week results from the RESTORE trial
© 2024 MJH Life Sciences

All rights reserved.