Entod Pharmaceuticals Gets CDSCO Panel Nod To study Pilocarpine Hydrochloride for Treatment of Presbyopia
New Delhi: Entod Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of Pilocarpine Hydrochloride Solution USP 1.25%w/v for the treatment of presbyopia in adult.
However, the approval came with conditions including that the firm should amend “Subject” instead of “Patient” throughout the clinical trial protocol.
In addition, the expert panel stated that in the inclusion criteria age group should be mentioned as 45 to 55 yrs (subgrouped into 40-45 and 50-55 years) instead of 40 to 55 yrs and female subjects with Menopause or surgically sterile should be included in the trial.
This came after the firm presented the proposal for manufacture and marketing permission of Pilocarpine Hydrochloride Solution USP 1.25%w/v for the treatment of presbyopia in adults along with Phase III clinical trial protocol, before the committee.
Presbyopia is the loss of clear close-up vision that happens when the eye’s lens becomes less flexible. Symptoms include blurry close-up vision, headaches, and eye strain.
Pilocarpine is in a class of medications called miotics. Pilocarpine ophthalmic treats glaucoma and ocular hypertension by allowing excess fluid to drain from the eye. Pilocarpine ophthalmic treats presbyopia by reducing the size of the pupils which helps to see objects up close.
Pilocarpine directly stimulates cholinergic receptors, acting on a subtype of muscarinic receptor (M3) found on the iris sphincter muscle, causing the muscle to contract and produce miosis.
Pilocarpine directly stimulates cholinergic receptors, acting on a subtype of muscarinic receptor (M3) found on the iris sphincter muscle, causing the muscle to contract and produce miosis. This effect is important in the short-term management of some angle-closure glaucoma.
At the recent SEC recent Ophthalmology held on 21st June 2023, the expert panel reviewed the proposal presented by Entod Pharmaceuticals for the manufacture and marketing permission of Pilocarpine Hydrochloride Solution USP 1.25%w/v for the treatment of presbyopia in adults along with Phase III clinical trial protocol.
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase III clinical trial as per the protocol presented subject to the following condition:
1. The firm should amend “Subject” instead of “Patient” throughout the clinical trial protocol.
2. In the inclusion criteria age group should be mentioned as 45 to 55 yrs (sub-grouped into 40-45 and 50-55 years) instead of 40 to 55 yrs.
3. Female subjects with Menopause or surgically sterile should be included in the trial.
4. No subject with any visually significant cataract should be included in the study.
5. Possible adverse reactions of Pilocarpine should be included in the ICD for awareness of the subjects.
Accordingly, the expert panel stated that the firm should submit the revised clinical trial protocol to CDSCO for approval.
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