Can eye drops be an alternative to your reading glasses?

If you are in your mid 40s and want to reduce your dependence on reading glasses, here’s some good news.A new eyedrop for presbyopia, a condition that impairs the ability to see things up close, was recently approved by India’s drug regulator.Mumbai-based Entod Pharmaceuticals has developed Pilocarpine Hydrochloride Ophthalmic Solution (brand name PresVu Eye Drops), which could potentially eliminate the need for reading glasses for millions of people globally affected by presbyopia.The drug-maker claims PresVu is a first-of-its-kind eye care medication in India. It received final approval from the Drug Controller General of India (DCGI) in August, based on recommendation by the Central Drugs Standard Control Organisation's (CDSCO) expert committee. However, in a new twist, the drug regulator on September 11 suspended the licence granted to the company to manufacture and market PresVu, insinuating that the manufacturer had made misleading claims.“In this regard, you are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 pc w/v is approved for the treatment of Presbyopia in adults and is not approved for such claim that these eye drop can enhance near vision without the need for reading glasses,” a DGCI order cited by news agency PTI read.Entod’s chief executive officer Nikkhil K Masurkar, however, refuted the charges and said the company will challenge the suspension in the court of law. “These are prescription eye drops. We take pride in our commitment to innovation and in providing healthcare solutions that are both accessible and affordable,” he said. A similar eye drops was approved by the US Food and Drug Administration (FDA) a few years ago. medium nocaption113418354How to use itAccording to Dr Dhananjay Bakhle, consultant pharmacologist and scientific adviser for Entod Pharmaceuticals, “PresVu drops contain an age-old product called Pilocarpine at a lower concentration of 1.25% (as compared to what was used for Glaucoma), which helps the lens to increase its convexity, allowing it to focus on the near objects, and thus the patient is able to read without glasses.”PresVu should be put as a single drop in each eye in the morning and its effect lasts up to 6-8 hours, he says. If there is a need, one more drop can be put in each eye after 6-8 hours to extend its effect. “Drops should be applied at least 15 mins before reading,” Bakhale explains.Phase 3 clinical trial of the medicine included 234 patients in the age-group of 45-55 years. While half of them were given PresVu, the other half received a matching placebo in a randomised controlled design. A placebo is a substance or treatment given to a patient during clinical trials, but it has no therapeutic value.“They [patients] put the eye drops once daily for 30 days and their ability to read without glasses under poor lighting conditions was measured. Significantly more subjects in the PresVu group had near vision improvement as compared to placebo in terms of reading 3 more additional lines on the Snellen’s chart that is used for testing near vision," Bakhale says. “Since all endpoints were met, efficacy of these drops at the end of 30 days was proven. Side effects were all mild and the incidence of these [was] also less than 3%. These side effects were eye irritation, redness, blurring & headache,” Bakhale adds.What doctors sayAccording to Dr Sujal Shah, director, Ophthalmology, Sir HN Reliance Foundation Hospital, the new eye drops work by temporarily improving the flexibility of the eye lens, which deteriorates with age. “When applied, the eye drops stimulates the muscles around the lens, helping it to change shape more easily and focus on nearby objects. However, it simultaneously also reduces pupil size and may reduce the amount of light entering the eye,” he says.PresVu is essentially diluted Pilocarpine (1.25%). Pilocarpine has been used in ophthalmology for many decades for the treatment of glaucoma (a condition that causes blindness by damaging the optic nerve), albeit in a more concentrated preparation (2%). Pilocarpine gradually lost popularity as more anti-glaucoma drugs became available in the market and also because of the risks of side effects such as pupillary constriction, induced nearsightedness and a higher risk of retinal detachment, says Dr Shah.“They [PresVu drops] can be applied about 15-20 minutes before reading or [doing] near activities. Generally, one needs to apply the drops two times a day. It is recommended for use under the supervision of an ophthalmologist, after a careful examination of the retina,” he says. medium113418698Do they have side effects?Doctors warn against long-term use of these eye drops. “Long-term use can reduce the pupillary tone, making it difficult to dilate the eyes in the future. It may precipitate acute angle closure glaucoma and can increase the risk of retinal detachments,” he says. As PresVu was launched recently, not much is known of its efficacy, safety profile and side effects, highlights Dr Shah. A similar drug has been in use in the US for about two years. However, there are reports of adverse effects such as headaches, blurring of vision, dimness of vision, redness, retinal tears, among others.Commenting on the Indian eye drops, Dr Komal Sangoi, cornea, cataract and refractive surgeon at Wockhardt Hospitals, Mumbai Central, says, “Unlike other treatments, no laser is done or implants are placed in the eye and hence it is non-invasive. Also, since it is only a drop application, it can be stopped anytime.” Although minor side effects like headaches, eye strain, light sensitivity, irritation, and stinging of eyes might happen initially, these will subside after sometime, she adds. medium113419140Avoid self-medicationDr Sangoi, however, stresses that one must get their eyes checked by an ophthalmologist to know whether it is safe for the person to use these drops. “Self-medication should be avoided,” she cautions.Dr Harshavardhan Ghorpade, an eye specialist at Fortis Hiranandani Hospital in Navi Mumbai’s Vashi, advises that individuals with high myopia or retinal weakness should use these drops with caution or avoid them altogether. “Regular retinal check-ups, or evaluations when sudden floaters or flashes occur, are also essential for those using these drops,” he says.Dr Ghorpade explains that PresVu eye drops only aid in near vision. “They cannot completely replace the use of near vision glasses as their effect is mild to moderate. “In older age-groups beyond 50, where the ciliary muscles [which contribute to a person’s ability to view objects clearly at varying distances] become even weaker, these drops may not be that effective,” he points out. The American eye dropsA similar formulation, which goes by the brand name Vuity, was launched in the US in 2022, and was subsequently approved by the country’s drug regulator. Currently, Vuity, manufactured by Abbvie, remains the only FDA-approved eye drop for treating age-related blurry vision.The recommended dosage for Vuity is one drop in each eye once daily. Studies are being carried out to evaluate multiple doses per day. Any contact lens that is being worn should be removed prior to administration of the eye drops. The solution begins to have an effect within 15 minutes and provides a sharper near image for 6 to 10 hours.DCGI’s flip-flop?In its suspension order, DCGI said the company made claims for the product for which it had not obtained approval from the Central Licensing Authority, thereby violating provisions under the New Drugs and Clinical Trial Rules, 2019.The drug regulator also said considering the various media reports, there was a likelihood of the general public being misled by the claims made by the company for which no approval was granted.Prior to that, DCGI had said that permission was granted to the company on August 20 for manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution for the treatment of presbyopia in adults. Then on September 4, the regulator had asked for an explanation from the company for the claims it made in the press, following which the drugmaker also submitted its response.Reacting to the suspension order, Entod CEO Masurkar said: “We at Entod Pharmaceuticals hereby declare that we have not made any unethical or false presentation of facts to the media or public when it comes to PresVu Eye Drops. All facts disclosed to the media were strictly on the basis of the recent DCGI approval for treatment of presbyopia in adults and the results of the phase 3 clinical trial conducted by us in India.”“Our approval by DCGI was based on a valid controlled clinical trial in 234 patients which was successful in showing efficacy and safety of these eye drops in patients of Presbyopia…Such eye drops with the same active ingredient and same concentration have been approved by the US FDA and marketed in the US for the last 3 years without any serious complications. FDA didn’t take any action on the companies marketing the same in the USA,” he claimed.