The drug development process is one of research and trials, which may introduce uncertainty for timing and results. These responses reflect the current expectations held at Chakshu Research and are subject to change. Therefore, we encourage you to revisit our website periodically to view announcements and stay apprised of our progress.
Frequently Asked Questions
Chakshu Research is a privately owned company currently undergoing the FDA approval process to treat people with cataract, glaucoma and asteroid hyalosis; vision problems associated with aging.
Cataract – We have recently completed a Phase I/II trial to improve vision in patients with cataract and the FDA has approved a Phase III trial for this indication. The planning and scheduling for this trial is underway, and a definitive timeframe has not yet been established.
Glaucoma – We are currently engaged in a Phase II trial for the treatment of elevated intraocular pressure in glaucoma patients. Any plans for future trials for this indication will be dependent upon the resulting data.
Asteroid Hyalosis – Chakshu is currently in a Phase II trial for asteroid hyalosis. Based on clinical data, we plan to conduct follow-up trials.
Once definitive plans have been completed for any future trials, announcements regarding the initiation of those trials will be made on our website; and the locations for trial sites are planned to be listed at ClinicalTrials.gov.
FAQ
When will your eyedrops be available?
Many factors determine the successful outcome and timing of the introduction of a new therapy for patient use. Contingent upon the completion of a pivotal trial and FDA approval, it could be several years before the ophthalmic solution is available for patient treatment.
How can I participate in a trial?
Chakshu does not directly identify nor recruit potential patients for a trial. Several eye clinics will be identified around the country, and they will recruit patients from their geographical areas. Potential participants are screened to determine if they meet all of the criteria for trial inclusion. (Some participants will randomly receive the placebo, an inactive control treatment.)
We plan to announce the initiation of future trials on our website, and the locations are typically listed at ClinicalTrials.gov.
Is this a treatment I should consider?
Chakshu Research is not a medical group nor clinic for treating ophthalmic or other medical problems. Questions regarding potential treatments should always be discussed with your physician.
When are your trials scheduled?
Chakshu has been approved by the FDA to proceed with a Phase III trial to improve vision in patients with cataract. The planning and scheduling for this trial is underway, and a definitive timeframe has not yet been established.
Upon the conclusion of our Phase II trial for treatment of elevated intraocular pressure in glaucoma patients, the resulting data will be evaluated to determine any future trial potential.
Chakshu expects to conclude our Phase II trial for asteroid hyalosis by mid–2009. Based on clinical data, we will initiate future trials.
We encourage anyone interested to periodically visit our website to watch for news and releases regarding trial date announcements. At that time, further information regarding these trials will be located at ClinicalTrials.gov.
Do you have published trial results?
No data has yet been released. Pre-clinical and clinical results are planned to be published in peer-reviewed journals.
Are you planning to address other diseases besides cataract?
We are currently engaged in a Phase II trial for treatment of elevated intraocular pressure in glaucoma patients. Upon the conclusion of this trial, the resulting data will be evaluated to determine any future trial potential.
We also have a Phase II trial for treating asteroid hyalosis underway. Upon the conclusion of this trial and contingent upon FDA approval, we plan to conduct follow-up trials.
Could your eyedrop be effective on other ocular diseases besides cataract and glaucoma?
Claims cannot be made about the effects of a treatment until it has successfully completed pivotal trials and received FDA approval. We are currently addressing vision loss from cataract, glaucoma and asteroid hyalosis.
Is your product available for the treatment of animals?
The safety and efficacy of drugs administered to animals must also be scrutinized. Therapies to treat animals are required to follow a specified approval process. Our ophthalmic solution has not been subjected to this regulatory process.
Are you a publicly traded company?
Currently, Chakshu Research is a privately owned company with no scheduled plans to become publicly traded.