Fact Check: Can Entod Pharma's PresVu get rid of reading glasses?

New Delhi: The recent claims made by various media reports based on the press note/conference of ENTOD pharma, stating that its product Presvu and its proprietary formula can get rid of reading glasses is Misleading. 

The Claim and its skyrocketing virality 

On 3rd September, 2024, pharma company, Entod Pharma organised a press conference where it announced the Drugs Controller General of India (DCGI) approval of the product. The press release that followed was titled " ENTOD Pharmaceuticals’ PresVu Eye Drops Approved by DCGI, Offering a Spectacular Treatment for Presbyopia, making reading possible without Spectacles" and stated that PresVu is the first eye drop in India specifically developed to reduce dependency on reading glasses for individuals affected by presbyopia, a common age-related vision condition that typically impacts those over 40.

"Presvu has also been applied for a patent for this invention in terms of its formulation and the process. The proprietary formula not only gets rid of reading glasses but also helps the patient lubricate their eyes as a side benefit. These eye drops utilise advanced dynamic buffer technology to swiftly adapt to tear pH, ensuring consistent efficacy and safety for extended use, keeping in mind that such drops will be used for years at a stretch," the press release stated

The release went on to add about the incidence and impact of presbyopia, as well as its impact. Presbyopia occurs as a natural consequence of aging when the eye’s ability to focus diminishes, leading to difficulty in focusing on close objects. This condition can significantly impact a person’s quality of life, affecting their ability to perform daily tasks and maintain their lifestyle. The release also contained quotes from Nikkhil K Masurkar, CEO of ENTOD Pharmaceuticals, who stated, “PresVu is the result of years of dedicated research and development. This DCGI approval is a major step forward in our mission to transform eye care in India. PresVu is more than just a product; it's a solution that stands to improve the lives of millions by offering them greater visual independence. We take pride in our commitment to innovation and in providing healthcare solutions that are both accessible and affordable.”

Dr. Dhananjay Bakhle, Scientific Advisor, Entod Pharma commented on the clinical potential of PresVu, stating, “The approval of PresVu is a promising development in the field of ophthalmology. For patients with presbyopia, this eye drop offers a non-invasive option that can enhance near vision without the need for reading glasses. Its rapid efficacy and safety profile, demonstrated in clinical trials, makes it a valuable addition to the treatment arsenal.”

Dr. Aditya Sethi, Ophthalmologist, was quoted in the release as stating, “Presbyopia has long been managed with reading glasses, contact lenses and surgical interventions but PresVu offers an advanced alternative that augments near vision within 15 minutes. This new treatment option is set to greatly improve the quality of life for many, allowing them to perform everyday tasks with newfound ease. It's important to monitor symptoms and seek medical advice if blurry close-up vision interferes with reading, close-up work, or other activities. Immediate medical attention is necessary for sudden blurred vision, flashes of light, or double vision.”

Following the press conference, Several media outlets reported about the eye drops claiming it as a spectacular treatment for Presbyopia and the potential to get rid of reading glasses. Times of India report was titled " Say goodbye to reading glasses: DCGI approves vision-correcting eye drops" started by stating" Imagine a world where we no longer need to reach for our reading glasses every time we pick up a book, check our phone, or at a menu. For millions of people over 40, this could soon be a reality....". Similarly, another report in ABP news was titiled," नजर का चश्मा लगाने से मिल जाएगा छुटकारा! DCGI की तरफ से इस आई ड्रॉप को मिली मंजूरी". Another report in NDTV was titled "All About PresVu, New Eye Drops That Can Remove Reading Glasses In 15 Mins. Similarly another news report in in myNation Hindi said "PressVu: गजब! सिर्फ 15 मिनट में हट जाएगा चश्मा, शानदार है ये आई ड्राप.| 

Fact check

The claim that Presvu can get rid of reading glasses is Misleading. PresVu eye drops may reduce dependence on reading glasses for certain individuals with presbyopia, but it is unlikely to fully "get rid of" the need for reading glasses in all cases. Presbyopia is a progressive, age-related condition, and while eye drops may improve near vision temporarily, they are not a cure. The phrasing in many of the news reports suggests a complete and permanent solution, which is likely overstated without long-term, conclusive clinical data. 

What Is Presbyopia

Presbyopia occurs when the eyes gradually lose the ability to focus on nearby objects. It is a natural part of aging and becomes noticeable after age 40. The word “presbyopia” is derived from Greek, meaning “old eye.” This condition occurs as the lens of the eye, located behind the iris, becomes more rigid and less flexible with age, making it difficult to focus on close-up tasks like reading or threading a needle. While presbyopia cannot be prevented or reversed, it can be managed with eyeglasses, contact lenses, medication, or surgery. Without correction, presbyopia can lead to eye strain and headaches.

What is Presvu

Presvu is a brand name of the ophthalmic drug by Entod Pharma that contains the generic molecule (pilocarpine hydrochloride ophthalmic solution) 1.25%, for topical ophthalmic use. It was initially approved in the United States in 1974 and has been used to treat glaucoma and ocular hypertension by allowing excess fluid to drain from the eye.

It was approved in the US under brand name Vuity for the treatment of Presbyopia, Medical Dialogues team had reported in 2021. In 2023, Entod Pharma got the approval from the CDSCO Panel, DCGI, the drug regulator in India to study Pilocarpine Hydrochloride for Treatment of Presbyopia

Pilocarpine ophthalmic treats presbyopia by reducing the size of the pupils which helps to see objects up close.

Pilocarpine hydrochloride is a cholinergic muscarinic agonist which activates muscarinic receptors located at smooth muscles such as the iris sphincter muscle and ciliary muscle. The drug contracts the iris sphincter muscle, constricting the pupil to improve near and intermediate visual acuity while maintaining some pupillary response to light. It also contracts the ciliary muscle and may shift the eye to a more myopic state.

While the data of Presvu brand is not traceable publicly, the systemic exposure to pilocarpine was evaluated in 22 participants with presbyopia who were administered 1 drop of VUITY  in each eye once daily for 30 days. The mean Cmax and AUC0-t,ss values on Day 30 were 1.95 ng/mL and 4.14 ng·hr/mL, respectively. The median Tmax value on Day 30 was 0.3 hours postdose with a range from 0.2 to 0.5 hours postdose.

In a clinical trial published by George O Waring et. al. found the onset effect of AGN-190584 (Allergan, an AbbVie company) which is an optimized topical formulation of pilocarpine hydrochloride, 1.25% was at 15 minutes.

The most common adverse reactions (>5%) of the drug include headache and conjunctival hyperemia, while warning and precautions include the following

1. Blurred Vision: Patients should be advised not to drive or operate machinery if vision is not clear (e.g., blurred vision). Exercise caution in night driving and other hazardous activities in poor illumination.
2. Risk of Retinal Detachment: Rare cases of retinal detachment and retinal tear have been reported with miotics,Individuals with pre-existing retinal disease are at increased risk. Therefore, examination of the retina is advised in all patients prior to initiation of therapy. Patients should be advised to seek immediate medical care with sudden onset of flashing lights, floaters, or vision loss.
3. Iritis: Caution is advised in patients with iritis. 

The drug is contradicted in patients with known hypersensitivity to the active ingredient or to any of the excipients.

So, is this a breakthrough, Spectacular Drug that gets rid of Reading Glasses?

Based on the analysis of the traceable public data around the molecule, the agent is does not seem to be a breakthrough or revolutionary drug. The molecule was first approved in ophthalmic conditions in 1974 and was particularly approved in the condition of Presbyopia in 2021 by the USFDA. 

Regarding the Claim Medical Dialogues Fact check Team, spoke to Dr Ishan Kataria, who informed, "It would be incorrect to classify this drug as a breakthrough treatment for presbyopia. It contains a diluted form of pilocarpine, which provides a temporary 'pinpoint effect' by constricting the pupil and ciliary muscles, similar to looking through a keyhole where light converges to enhance near vision. While this may reduce dependency on reading glasses, it cannot fully eliminate the need for them, as presbyopia is a natural, age-related condition that typically affects those over 40. For individuals above 50, the drops might reduce the need for stronger lenses, e.g- potentially bringing a prescription of +3.0 down to +1.5, but no further. Although the drops work within 15 minutes, their effect is temporary, and without regular use, the benefits will diminish. Additionally, pilocarpine has a known history of side effects, including headaches and, in rare cases, retinal detachment, particularly when used in higher concentrations for glaucoma. Therefore, it may not be suitable for everyone."

The Aftermath of the Viral Claim

With several media reports pointing this as a "breakthrough" or "revolutionary"  drug, drug officials came out condemning the reports as false presentation of facts

The claims made by ENTOD Pharmaceuticals about its product PresVU eye drops being approved by DCGI and offering spectacular treatment for Presbyopia are unethical and false presentation of facts, said a top official source to ANI news agency. "This is unethical and false presentation of facts," said the official source. The company has been asked for an explanation for the false representation by the drug regulator, "Explanation has been asked from the company." Said top official sources.

Response of the company

In response to the queries of Medical Dialogues, ENTOD Pharmaceuticals dismissed allegations that it made unethical or false presentation of facts to the media or public about its product, PresVu eye drops.

Nikkhil K Masurkar, CEO, Entod Pharmaceuticals, said in a statement late Thursday evening, "We at ENTOD Pharmaceuticals hereby declare that we have not made any of the unethical or false presentation of facts to the media or public when it comes to PresVu eye drops. All facts disclosed to the media are strictly based on the approved indication for treatment of presbyopia in adults and the Phase 3 clinical trial data generated by us. "

The company further mentioned that the opinions and claims printed in news stories do not represent ENTOD Pharmaceuticals. "Some of the opinions and claims printed in news stories do not represent that of ENTOD Pharmaceuticals or any of its spokespeople. The widespread media interest in such a therapy has been unprecedented and has led to sensationalization of the story."

Final Verdict

The press release and the various reports are misleading as they seem to overstate the role of Pressvu as a breakthrough or a revolutionary drug that can get rid of reading glasses. While there is merit in the use of drugs in improving vision in presbyopia, this improvement is temporary and requires the reuse of drug again and again implying the solution is not permanent. Hence, the claims surrounding Presvu getting rid of reading glasses are misleading