Clarity of vision: On eye drops for presbyopia and ‘claims’
A useful drug is undone by fantastic claims about its efficacy
The casual exaggeration of claims in medicine, unsubstantiated by science and facts, has long been a plague in the health sector. The promise of spectacular cures advertised in the media from time to time, in fact, prompted separate legislation to curb such claims: the Drugs And Magic Remedies (Objectionable Advertisements) Act. Last week, controversy over the claims over the prowess of eye drops prescribed for presbyopia (progressive loss of the near focusing ability of the eye due to ageing), led to the Central Drugs Standard Control Organisation (CDSCO) suspending a pharma company’s permission to manufacture and market the product. The CDSCO said that the company had made claims, for which it had not been authorised (that using the drops could lead to reading glasses not being needed for presbyopia). “In view of public interest, and due to the likelihood of the public being misled by these claims,” permission had been suspended. The company, ENTOD Pharmaceuticals, held that approval for the drug was based upon a valid controlled clinical trial that demonstrated efficacy and safety in 234 patients. It ladled the blame for the ‘claims’ on to media reports on the new product “which went viral and public imagination [that] led to an unusual escalation for which ENTOD Pharmaceuticals is not responsible”. Despite these protestations, the company had posted a message on X (since deleted) tagging Prime Minister Narendra Modi: “PresVu is the first DCGI-approved proprietary prescription eye drops to eliminate the need for reading glasses”.
The main ingredient in the drops, pilocarpine, works by causing the pupils to constrict, creating a pinhole effect. This would enable someone with presbyopia to see better. Pilocarpine, itself, is not a new application in ophthalmology, or even, presbyopia. It has been used to treat glaucoma, though its use waned because of the side effects, and has since been replaced by better drugs. The U.S. FDA had, in 2021 and 2023, approved pilocarpine-based eye drops for use in presbyopia. While the announcement of these approvals was publicised at the time, the communiqués mentioned the advantages of using the eye drops, along with the side effects, a measured claim about offering another option for presbyopes, in addition to glasses, contact lenses and surgery. The intervention of the CDSCO in this case, clearly is an attempt to reinforce the Drugs and Magic Remedies Act. This is a valid intervention in India today, where frequent advertisements for fantastic cures indicate the presence of an industry that thrives on cheating gullible patients. It is the duty of the government to set store entirely by scientific data, and rein in unsubstantiated claims about drugs, no matter who makes them.