The Indian drug regulatory body, the Drugs Controller General of India (DCGI), has dealt a significant blow to PresVu, an eye drop promising to replace reading glasses, by suspending its regulatory approval before it could even reach the market. This decision, citing “unauthorised promotion” and concerns over the “unsafe use” of the eye drops, leaves the product’s future uncertain.
Entod Pharmaceuticals, the Mumbai-based manufacturer of PresVu, had made a bold claim earlier in September, positioning their product as “India’s first eye drop specifically developed to reduce dependency on reading glasses” for individuals suffering from presbyopia. This age-related condition diminishes the eye’s ability to focus on nearby objects, commonly affecting those over 40.
PresVu, containing the ingredient pilocarpine, works by reducing pupil size, thereby improving near vision. The company claimed a single drop could take effect within 15 minutes, lasting up to six hours, with the option of prolonging the effect with a second drop.
However, the DCGI intervened on Tuesday, revoking the product’s marketing and manufacturing approvals after concerns arose regarding the validity of Entod’s claims. Specifically, the DCGI found that the company’s promotional material went beyond what was authorised, despite receiving approval for PresVu Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 per cent.
The disputed claims included:
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Claim 1: “First eye drops in India designed to reduce the need for reading glasses.”
The DCGI countered that Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 per cent wv had not been approved for any claim related to reducing reading glasses dependency.*
Claim 2: “This eye drop offers a non-invasive option that can enhance near vision without the need for reading glasses.”
The DCGI asserted that while the solution is approved for treating presbyopia in adults, it is not approved for claims that it can enhance near vision without requiring reading glasses.*
Claim 3: “Pres Vu can provide an advanced alternative that augments near vision within 15 minutes.”
The DCGI reiterated that the solution’s approval for treating presbyopia does not extend to claims that PresVu can augment near vision within 15 minutes.The DCGI highlighted that Entod had failed to obtain prior approval from the Central Licensing Authority for these promotional claims. The Union Ministry of Health and Family Welfare also voiced concerns about the product being marketed like an over-the-counter drug when it was only approved for prescription use. The ministry expressed apprehension about potential unsafe use and safety hazards to the public due to unauthorised promotion in media and social media.
Entod Pharmaceuticals has responded to the suspension by announcing its intention to challenge the CDSCO’s decision in court. The company’s CEO, Nikkhil K Masurkar, insists that Entod has not misrepresented facts to the media or public. He emphasizes that Entod disclosed all information to the DCGI during a successful phase 3 clinical trial involving 234 patients, which demonstrated the eye drops’ efficacy and safety in presbyopia patients.
Masurkar further points out that eye drops with the same active ingredient and concentration have been approved by the US FDA and marketed in the US for the past three years without serious complications, and that the FDA did not take any action against the company’s marketing practices in the US.
Entod maintains that their fight is not just about PresVu, but about encouraging innovation and research within the Indian pharmaceutical sector, particularly within the MSME sector. Their challenge of the suspension aims to ensure that innovative medicines reach the Indian market without encountering similar obstacles.
The saga of PresVu serves as a reminder of the stringent regulatory environment surrounding new medications and the importance of transparency and evidence-based claims in the pharmaceutical industry.
