New Delhi: Amid hype over the launch of an eye drop that promises to replace reading glasses, the All India Ophthalmological Society (AIOS)—the top professional body of India’s ophthalmologists—is forming a panel to assess its safety, keeping in mind the drug’s “potential inappropriate marketing” and possible “indiscriminate use”, ThePrint has learnt.
Mumbai-based pharmaceutical firm Entod Pharmaceuticals launched the eye drop Tuesday under the brand name PresVu. Its active ingredient is pilocarpine hydrochloride 1.25 percent. The firm claims the eye drop will help people aged 40-55 with presbyopia (age-related blurry eye condition characterised by inability to focus on nearby objects) ditch reading glasses.
Pilocarpine, which is known to shrink the size of pupils, has been used to treat glaucoma (eye conditions that can lead to blindness) for decades. Last month, the Central Drugs Standard Control Organisation (CDSCO) approved the above-mentioned formulation and concentration of pilocarpine to treat presbyopia in middle-aged people.
A similar drug, sold under the brand name Vuity by Dublin-based pharmaceutical firm Allergan, an AbbeVie company, was approved by the US Food and Drug Administration (FDA) in October 2021.
However, the AIOS decided Thursday to constitute an expert group, stating that approval of the drug and its subsequent use by people may lead to a “public health challenge”.
An expert panel under AIOS is being tasked with evaluating and suggesting “measures that the Society may take to address the issues surrounding the recently approved 1.25 percent pilocarpine eye drops for presbyopia correction”.
The panel will assess the eye drop’s “safety in view of the potential inappropriate marketing and risk of dispensing without a prescription, resulting in an indiscriminate use”.
ThePrint has seen a copy of the internal order passed by the AIOS in this regard.
The panel has also been asked to suggest the need and possibility of appealing against CDSCO’s approval; create evidence-based guidelines regarding the safety profile, side-effects, relative and absolute contraindications; and measures that the AIOS must take to educate its members and the community.
ThePrint reached AIOS president Dr Samar Basak via calls. This report will be updated if and when a response is received.
Entod Pharmaceuticals CEO Nikkhil K. Masurkar had earlier told ThePrint that the eye drop was tested in 250 Indian participants in a phase 3 clinical trial and will be available across pharmacies in the country from October this year.
He added that only minor, transient side effects such as redness in eyes were observed in few participants of the clinical study.
Masurkar said that the company has made it clear that PresVu is a prescription-only medication, available only after a confirmed diagnosis of presbyopia by a registered eye specialist. He added that the decision to prescribe PresVu is entirely based on the doctor’s discretion.
“I also stressed the importance of regular eye checkups for all, regardless of age. Regrettably, some media stories have highlighted certain aspects of the story, leading to misinterpretations,” the CEO said to ThePrint.
“We would like to convey that we are not responsible for any marketing missteps or claims of improper promotion. The current media portrayal does not reflect the true message delivered during the press conference (by Entod),” he added.
Also Read: Demand soars for twice-a-year jab to lower bad cholesterol. Here’s how it works
Safety issues with pilocarpine
Pilocarpine is a plant-derived molecule that has been used for decades to treat various eye conditions and dry mouth, and reduce eye pressure, among other applications.
Dr Sreeni Edakhlon, a member of the AIOS management committee, told ThePrint that questions on the possible adverse effects of continuous and regular use of pilocarpine hydrochloride 1.25 percent for the treatment of presbyopia need to be addressed.
“Even though pilocarpine 1 and 2 percent have been indicated for glaucoma for decades, it is not a drug of choice to treat the disease in most patients now, as there are safer options available now,” Dr Edakhlon said.
Doctors ThePrint spoke to said that pilocarpine-induced miosis (contraction of pupils) begins 15 to 30 minutes after application and lasts for 4-8 hours, and hence, a single dose every morning will not be sufficient to sustain the effects till evening.
Also, patients with lenticular opacities (irregularity in ordered arrangement of lens fibres necessary to maintain lens transparency) caused by the degeneration of lens fibres, will have decreased vision in dim illumination and must be warned of the dangers of night driving if they use the eye drop in the evening.
Additionally, there can be changes in distance vision due to fluctuating myopic shifts in refraction (increase in myopia or near-sightedness) and hence, it needs to be carefully examined whether an improvement in near vision comes at the cost of compromised distance vision, Edakhlon, who is also medical director of Comtrust Charitable Trust Eye Hospital in Thalassery, Kerala, said.
Pilocarpine can alter lens permeability, potentially leading to a shift in lens cations (positively-charged ions) and water accumulation which, in turn, can cause changes in the intraocular metabolism (metabolism in eye which involves enzymes that help prevent or eliminate foreign particles in the eye).
Moreover, the use of pilocarpine may cause the lens to become more opaque, Edakhlon said. “Hence, the long-term adverse effects of the drug should be kept in mind. Pilocarpine binds to melanin (pigments that give colour to the eye) in the iris and ciliary body (ring-shaped muscle that changes shape of eye lens when it focuses on something, and forms the liquid filling the eyeball). Hence, iris colour may influence the drug’s desired response.”
Patients with darkly pigmented irides may require a higher concentration of pilocarpine to obtain maximum effect, he stressed, adding that the effect of 1.25 percent pilocarpine on Indian eyes and whether the 1.25 percent concentration suffices the desired effect on near vision, needs to be studied.
Vuity associated with retinal detachment in some cases
An ophthalmologist at Safdarjung Hospital in Delhi also maintained that careful examination of the peripheral retina (part of retina or back of the eye that provides peripheral and night vision) is mandatory before prescribing pilocarpine, and this increases the responsibility of eye doctors to perform thorough examination of the retinal periphery before prescribing the drug.
“That’s because some people are more prone to retinal detachment than others and given that even drugs that should be available only on prescription in India can be easily accessed at pharmacies—we are very concerned about people randomly using it and getting adversely affected,” the ophthalmologist, who requested anonymity, told ThePrint.
Retinal detachment is a serious condition in which a thin layer of retinal tissue pulls away from its normal position.
Though such cases were not recorded in clinical trials of Vuity, cases of retinal tear and retinal detachment, among several side effects, had been reported since it was marketed in the US.
“It is for this reason that Vuity is not prescribed for treating presbyopia in the US by most ophthalmologists,” Edakhlon said.
Data from clinical trials of PresVu have not been made public yet, but Masurkar told ThePrint earlier that the data will soon be published in a peer-reviewed medical journal.
Edakhlon, meanwhile, warned that increased permeability of the blood–aqueous barrier (in the eyeball) is another side effect of the drug which should be kept in mind.
“Long-term use will cause permanent miosis due to the loss of tone (tension) in the iris radial muscles and fibrosis (development of fibrous connective tissue to replace damaged tissue) of the pupillary sphincter (muscle located in iris that constricts pupil) and may result in posterior synechiae (condition in which iris adheres to lens), causing difficulty in dilatation (expansion) for examination of retinal periphery and adequate dilatation for cataract surgery, if the patient requires it in future,” Edakhlon said.
Dr K.V. Babu, another ophthalmologist from Kerala, sent a letter Friday to the Drugs Controller General of India (DCGI), who heads the CDSCO, pointing out that India’s Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, prohibits advertisement of certain drugs for treatment of certain diseases and disorders.
These include diseases of the optical system and therefore, presbyopia is one of the disorders for whose treatment a product cannot be publicised or advertised.
Therefore, the DCGI should examine the case for the violation of the DMR Act, the letter, viewed by ThePrint, said.
(Edited by Radifah Kabir)
Also Read: Over 60% drug cocktails used for mental illnesses in India unapproved by apex regulator, finds study