Swathi Madhavan, M.Optom
Tutor, Vision Science Academy Learning Centre
Introduction
According to recent updates, in April 2024, the field of eye care officially witnessed an innovation in a treatment approach. PresVu, a novel therapeutic intervention developed by Entod Pharmaceuticals, has been claimed to offer an advanced pharmacological solution for presbyopia management. (1) This discovery is believed to replace the alternative conventional treatment approaches to presbyopia such as, reading glasses and multifocal lenses. Its innovative formulation and rapid onset of action are believed to make it a breakthrough, especially for the pre and presbyopic population.
Composition and Mechanism of Action
The active ingredient in PresVu is pilocarpine HCl 1.25%, a muscarinic receptor agonist, with well-documented effects on pupillary dynamics and lens accommodation. (2)
The therapeutic effects of this drug combination are achieved through two mechanisms – miosis and lens accommodation.
- Miosis: Pilocarpine induces contraction of the sphincter pupillae, resulting in pupil constriction (miosis). This eventually enhances near-vision clarity by improving the depth of field and reducing peripheral aberrations.
- Lens Accommodation: The drug also stimulates the ciliary muscle leading to accommodation. This effect is particularly beneficial in counteracting the accommodative decline seen in presbyopia.
Another unique feature of PresVu is its Dynamic Buffer Technology. It is claimed to enable the formulation to adapt to the physiological pH of the tear film, enhancing comfort and ensuring the consistency of the drug’s efficacy over prolonged usage. (3) As pH imbalance can lead to ocular discomfort, this technology can help maintain the balance, promote better tolerability and patient adherence.
Efficacy and Duration of Action
The efficacy of PresVu has been validated through multiple clinical studies, notably the Virgo Phase 3 trial, which demonstrated statistically significant gains in mesopic, high-contrast, binocular distance-corrected near visual acuity (DCNVA). The therapeutic effects typically last between four to six hours, necessitating twice-daily administration for sustained visual improvement in some patients. (4)
Safety Profile and Side Effects
As with all pharmacological treatments, PresVu is reported to carry a risk of side effects, albeit minor. Reported adverse events include ocular discomfort, conjunctival hyperaemia, eyebrow pain, and transient spasms of the ciliary muscle. These side effects are generally mild and self-limiting, but practitioners should monitor patients for tolerance and efficacy over time. (5, 6)
Though this innovative advancement is a breakthrough in presbyopia management, there is more to its journey into practical eye care. As eye care professionals, it is our duty to learn about these aspects and stay updated. The approval of the PresVu and its release into the market have presented a few serious and unexpected complications which are to be studied further.
For more on the regulatory aspects and market impact of PresVu, refer to our second blog, “From Approval to Market Impact: The Journey of PresVu Eye Drops”
This blog has been prepared and published solely for educational purpose.
References:
- Express Pharma. (2023, April 9). Entod Pharma gets CDSCO approval for eye drops to treat presbyopia. Express Pharma. https://www.expresspharma.in/entod-pharma-gets-cdsco-approval-for-eye-drops-to-treat-presbyopia/ [Last Accessed: 06 Nov 2024; 07:50pmAEDT]
- 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
- 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; 07:55pmAEDT]
- NDTV. (2023, March 26). All about PresVu: New eye drops that can remove reading glasses in 15 mins. NDTV. https://www.ndtv.com/india-news/all-about-presvu-new-eye-drops-that-can-remove-reading-glasses-in-15-mins-6488271 [Last Accessed: 06 Nov 2024; 07:45pmAEDT]
- CivilsDaily. (2023, March 27). PresVu: India’s first eye drop for presbyopia. CivilsDaily. https://www.civilsdaily.com/news/presvu-indias-first-eye-drop-for-presbyopia/[Last Accessed: 06 Nov 2024; 07:48pmAEDT]
- The Hindu. (2023, March 29). DCGI gives approval for Indian eye drops developed to reduce dependency on reading glasses. The Hindu. https://www.thehindu.com/sci-tech/health/dcgi-gives-approval-for-indian-eye-drops-developed-to-reduce-dependency-on-reading-glasses/article68601139.ece [Last Accessed: 06 Nov 2024; 07:49pmAEDT]
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