Swathi Madhavan, M.Optom
Tutor, Vision Science Academy Learning Centre
PresVu eye drops, once considered a major innovation for presbyopia, have faced an unrestrained journey. Developed by Entod Pharmaceuticals, PresVu was marketed as a breakthrough in non-invasive presbyopia treatment. (1) However, issues surrounding its marketing and claims have since led to its suspension.
Regulatory Approval and Market Excitement
PresVu was initially approved by the Drug Controller General of India (DCGI) after a thorough review by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO). The approval was based on promising clinical data, with its active ingredient, pilocarpine HCl 1.25%, showing potential for presbyopia treatment. (2, 3)
Entod Pharmaceuticals marketed PresVu as an alternative to reading glasses, highlighting its Dynamic Buffer Technology, which adapts to tear pH for sustained comfort and efficacy. Clinical studies like the Virgo Phase 3 trial showed significant improvement in near vision, fuelling initial excitement about the product.
The Suspension: Unethical Practices and Misrepresentation
Despite early success, PresVu’s approval was suspended due to unethical and misleading marketing claims. Regulatory authorities, including the CDSCO, discovered that clinical data was misrepresented to exaggerate PresVu’s benefits. Claims about rapid improvement in near vision and long-lasting effects were inconsistent with actual clinical trial outcomes.
Entod Pharmaceuticals was also found to have downplayed side effects, such as ocular discomfort, eyebrow pain, and muscle spasms, in its marketing materials. The discrepancies between clinical data and marketing claims raised ethical concerns, leading to the withdrawal of the product from the market pending further investigation. (4)
Impact on the Market and Vision Care
The suspension of PresVu has had significant consequences for both healthcare professionals and patients. Many optometrists and prescribers, initially optimistic about the drug, have expressed concerns over the mismatch between the trial data and the actual product experience.
Entod Pharmaceuticals’ credibility has also suffered, as trust in their product development and marketing practices has eroded. Pharmacies and distributors have pulled PresVu from their shelves, and the drug is currently unavailable in India. The case underscores the need for ethical marketing and transparent clinical trials in the pharmaceutical industry.
Clinical Studies and Lessons Learned
The Virgo Phase 3 trial, which initially supported PresVu’s approval, was re-evaluated after the suspension. It became clear that long-term efficacy data were not as consistent as first reported, with several trial participants experiencing limited improvements or shorter durations of action than promised. This highlighted the importance of full transparency when presenting clinical trial outcomes.
Conclusion
The suspension of PresVu has brought attention to the critical need for ethical clinical practices and accurate marketing in pharmaceutical care. For optometrists and vision care specialists, this controversy serves as a reminder to scrutinise clinical data and ensure patient safety when prescribing new treatments. The future of PresVu remains uncertain, with further investigations ongoing to determine whether it will return to the market under stricter regulations.
This blog has been prepared and published solely for educational purposes.
References:
- Elets eHealth. (2024, April 11). Entod Pharmaceuticals introduces PresVu eye drops to combat presbyopia. Elets eHealth. https://ehealth.eletsonline.com/2024/04/entod-pharmaceuticals-introduces-presvu-eye-drops-to-combat-presbyopia/ [Last Accessed: 06 Nov 2024; 08:00pmAEDT]
- Meghpara, B. B., Lee, J. K., Rapuano, C. J., Mian, S. I., & Ho, A. C. (2022). Pilocarpine 1.25% and the changing landscape of presbyopia treatment. Current Opinion in Ophthalmology, 33(4), 269–274. https://doi.org/10.1097/ICU.0000000000000864CDSCO Regulatory Update
- Bhanot, P. (2023, August 23). DGCI licenses eye drop as an alternative to near vision glasses. The Indian Express. https://indianexpress.com/article/health-wellness/dgci-license-eye-drop-near-vision-glasses-9562250/ [Last Accessed: 06 Nov 2024; 08:03pmAEDT]
- Pharmaceutical Technology. (2023, December 7). India suspends Entod license for eye drops. Pharmaceutical Technology. https://www.pharmaceutical-technology.com/news/india-suspends-entod-licence-drops/ [Last Accessed: 06 Nov 2024; 08:05pmAEDT]
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