Caplin Point Labs gains as arm gets USFDA nod for eye infection treatment drug

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Caplin Point Laboratories Ltd shares gained over 2% on Tuesday after the company said that its subsidiary Caplin Steriles Ltd has received final approval from the United States Food and Drug Administration (USFDA) for an eye infection treatment drug.

The company, in a stock exchange filing, said that its subsidiary has received approval from the US drug regulator for Ofloxacin Ophthalmic Solution, used in treating eye infection.

The company has received the Abbreviated New Drug Application (ANDA) Ofloxacin Ophthalmic Solution USP 0.3%, a commonly used eye drop.

This clearance positions Caplin as a player in the generic therapeutic equivalent market, offering an alternative to the branded version, OCUFLOX Ophthalmic Solution of Allergan Inc, Caplin Point Labs said in a stock exchange filing.

Ofloxacin Ophthalmic Solution USP 0.3% is indicated for the treatment of eye infections, especially conjunctivitis and corneal ulcers.

With this approval, Chennai-based Caplin aims to provide patients with effective treatment options.

According to IQVIATM (IMS Health), Ofloxacin Ophthalmic Solution USP 0.3% recorded significant sales in the US, with approximately $52 million in revenue for the 12-month period ending December 2023.

This shows the market demand and potential for Caplin’s generic version.

Caplin Steriles has developed and submitted 41 ANDAs in the United States, both autonomously and in collaboration with partners, resulting in 27 successful approvals to date. Additionally, the company is actively engaged in developing a diverse portfolio of over 40 simple and complex Injectable and Ophthalmic products, slated for submission over the course of the next four years.

Furthermore, Caplin Steriles has numerous products currently under review and approved in various international markets outside the US, including Mexico, Australia, Canada, South Africa, among others.

In February, Caplin Point Laboratories announced that it expects the introduction of four new products in the ophthalmic injectables sector in the US, which are poised to significantly contribute to the company’s growth in the American market.

Shares of Caplin Point Laboratories were trading 1.35% higher at ₹1,318 apiece on the NSE at 2.48 PM.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow