Indian pharma sees immense relevance to US FDA norms for drug development for age-related macular degeneration

Bengaluru, March 4, 2023 :

Indian pharma sees immense relevance to the US FDA norms for drug development for age-related macular degeneration. The condition is a serious vision loss which mandated the need for new drugs.

It is here the industry is of the view that a direction from the regulatory authority on the development guidance for the Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment will speed up the process of the research and manufacture.

Tilted as the Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment, US FDA has noted that this guidance is intended to provide recommendations to sponsors regarding eligibility criteria, trial design considerations, and efficacy endpoints to enhance clinical trial data quality and to foster greater efficiency in development programs for drugs for the treatment of neovascular age-related macular degeneration.

For consideration of clinical trials, the global regulatory authority has noted that sponsors developing drugs for the treatment of neovascular age-related macular degeneration recommends parallel-group, randomized by patient, double-masked trials in which the investigational drug group demonstrates superiority over the control group.
Alternatively, FDA recommends parallel-group, randomized by patient, double-masked trials in which the investigational drug group demonstrates non-inferiority either to ranibizumab injection administered intravitreally every 4 weeks or or every 8 weeks after 3 monthly injections.

Trials should include patients older than 50 years of age from relevant demographic subsets, including both men and women and multiple racial/ethnic and eye color groups. Patients should have choroidal neovascularization documented by fundus photography, fluorescein angiography, or optical coherence tomography. For a trial designed as a superiority study, the sponsor should enroll patients with neovascularization caused by age-related macular degeneration who have had visual loss or would be expected to develop visual loss.

In general, safety and efficacy should be demonstrated in at least two adequate and well-controlled, multicenter trials utilizing different investigative sites. One eye per patient should be pre-specified as the study eye for the purposes of the efficacy analysis even if both eyes are treated. Both eyes should be followed for safety, stated the global regulatory authority.

Further, it recommends that approximately 400 or more patients using the investigational drug complete treatment with a concentration of the investigational drug at least as high as proposed for marketing and with a dosing frequency at least as frequent as proposed for marketing. Before submission of a marketing application, the sponsor should ensure that at least 300 patients have completed at least 9 months of follow-up after the initiation of treatment.

In India and globally, the prevalence and determinants of age-related macular degeneration are in the 50 years and older population. The condition is also known to manifest in the 40 years age group because of continuous computer and mobile screens. Largely ophthalmologists note that the condition is a serious vision loss cause which mandated the need for new drugs. Pharmabiz