The US FDA guidance on dry eye drug development for industry is seen by pharma industry players to bolster development programmes for drugs for the treatment of dry eye. The condition is seen as a critical one for all age groups across the world driven by environmental pollutants and addition cell phone –computer screen time.
According to the global regulator, 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 drug therapy for dry eyes.
According to a section of ophthalmologists from the Minto Ophthalmic Hospital in Bengaluru, a venue where extensive human studies take place for both Indian and global pharma, the guidance will give the much needed direction to companies to come out with the right formulation for dry eyes.
Sponsors developing drugs for the treatment of dry eye should consider both traditional environmental exposure trials and challenge-model trials utilizing a controlled chamber with regulated temperature, air flow, humidity, can be acceptable.
The regulator recommends parallel, randomized by patient, double-masked trials in which the investigational drug group demonstrates superiority over the control group. Here US FDA recommends that efficacy be demonstrated in single-day, controlled environment trials. Safety trials are to be conducted at least 6 weeks in duration if efficacy trials are of shorter duration.
Water is known to be an effective component of topically applied treatments for dry eyes. Therefore, in general, comparative clinical trials should use the investigational drug’s vehicle as a control agent. The sponsor should enroll patients with ocular complaints consistent with dry eye symptoms. Patients from relevant demographic subsets should be studied, including both men and women and multiple age, racial/ethnic, and eye color groups.
Dry eye secondary to scarring such as that seen with irradiation, alkali burns, vitamin A deficiency) represent a specific, severely affected patient population.
Symptoms of dry eye include, but are not limited to, blurred vision, light sensitivity, sandy or gritty feeling, ocular irritation, ocular pain or discomfort, and ocular itching. Efficacy for a sign and efficacy for a symptom do not have to be demonstrated in the same clinical trial, but each should be demonstrated in more than one clinical trial.
The clinical program should include enough patients to identify adverse drug events that occur at a rate of 1 per cent or greater. To accomplish this, FDA 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.
Before submission of a marketing application, the sponsor should ensure that least 300 patients have completed at least 6 weeks of follow-up after the initiation of treatment and at least 100 patients have completed 12 months of follow-up after the initiation of treatment.
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The US FDA guidance on dry eye drug development for industry is seen by pharma industry players to bolster development programmes for drugs for the treatment of dry eye. The condition is seen as a critical one for all age groups across the world driven by environmental pollutants and addition cell phone –computer screen time. |
