Glaukos Corporation (GKOS Quick QuoteGKOS - Free Report) announced positive top-line data from two pivotal studies evaluating its targeted injectable implant candidate — iDose TR — in glaucoma patients. Data from the studies showed that the slow-release iDose TR achieved excellent tolerability and a favorable safety profile. The candidate achieved non-inferior reductions in intraocular pressure (IOP) in three months from baseline compared to the timolol ophthalmic solution.

Price Performance

Shares of Glaukos rallied 18.5% on Sep 7, following the data readout. Shares of the company have gained 28.2% so far this year against the industry’s 32.4% fall and the S&P 500's 18.7% decline.

Based on these data, the company is planning to file a new drug application (NDA), seeking approval for iDose TR from the FDA by the end of 2023.

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Study Data

Two phase III studies — GC-010 and GC-012 — evaluated both fast- and slow-release iDose TR in two separate arms for a reduction in IOP in patients with open-angle glaucoma (OAG) or ocular hypertension. Data from the studies showed that both fast- and slow-release iDose TR achieved the pre-specified primary efficacy endpoint of non-inferiority to the active comparator arm.

The slow-release iDose TR achieved 6.6-8.5 mmHg and 6.7-8.4 mmHg reductions in IOP from baseline in GC-010 and GC-012 studies compared with timolol’s reduction of 6.6-7.7 mmHg and 6.8-7.2 mmHg, respectively, in three months.

Moreover, 93% of the patients treated with slow-release iDose TR remained well-controlled on the same or fewer IOP-lowering topical medications at 12 months compared to 67% of the patients receiving timolol. Among patients treated with slow-release iDose TR, 81% were completely free of IOP-lowering topical medications at 12 months.

Based on the data from the two studies, Glaukos believes that iDose TR can be a transformative novel technology that will be able to fundamentally improve the glaucoma treatment paradigm for patients. Per the company, there is an important unmet clinical need within this ophthalmic community for safe, effective and sustained dropless pharmaceutical alternatives to traditional topical medications. This will likely result in strong demand for treatments like iDose TR.

Glaukos Corporation Price

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Glaukos plans to file the NDA for the slow-release iDose TR model.

iDose TR is a novel formulation of travoprost, a prostaglandin analog used to reduce IOP. iDose TR is designed in a way that it can be replaced with a new unit following the release of the travoprost contained in the device. The company is developing the device as an alternative to daily eye drop treatment.

Zacks Rank & Key Picks

Currently, Glaukos carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the broader medical space are AMN Healthcare Services, Inc. (AMN Quick QuoteAMN - Free Report) , ShockWave Medical, Inc. (SWAV Quick QuoteSWAV - Free Report) and McKesson Corporation (MCK Quick QuoteMCK - Free Report) .

AMN Healthcare, sporting a Zacks Rank #1 (Strong Buy) at present, has an estimated long-term growth rate of 3.2%. AMN’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average beat being 15.7%.

You can see the complete list of today’s Zacks #1 Rank stocks here.

AMN Healthcare has lost 10.1% compared with the industry’s 37.4% fall in the past year.

ShockWave Medical, sporting a Zacks Rank #1 at present, has an estimated growth rate of 33.1% for 2023. SWAV’s earnings surpassed estimates in all the trailing four quarters, the average beat being 180.1%.

ShockWave Medical has gained 20.1% against the industry’s 34.1% fall over the past year.

McKesson, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 9.9%. MCK’s earnings surpassed estimates in three of the trailing four quarters and missed the same in one, the average beat being 13%.

McKesson has gained 75% against the industry’s 16.3% fall over the past year.